Comparing the maternal and neonatal outcomes in vaccinated and unvaccinated pregnant women against COVID-19: a retrospective cohort study

Comparing the maternal and neonatal outcomes in vaccinated and unvaccinated pregnant women against COVID-19: a retrospective cohort study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Comparing the maternal and neonatal outcomes in vaccinated and unvaccinated pregnant women against COVID-19: a retrospective cohort study Zahra Gholami, Maryam Mohseni, Pouran Allahbakhshi Nasab This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5349935/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 28 Mar, 2025 Read the published version in BMC Pregnancy and Childbirth → Version 1 posted 4 You are reading this latest preprint version Abstract Background After the emergence of the COVID-19 disease due to the limited number of studies on vaccination of pregnant mothers and the fact that the vaccine used in Iran has been different from the ones employed in other countries, this study aimed to compare maternal and neonatal outcomes in vaccinated and unvaccinated women against COVID-19. Methods This retrospective cohort study was done in the comprehensive healthcare centers of Rafsanjan city. First, the contact information of expectant mothers who were pregnant from 22th June 2021 to 22th December 2021 was extracted using Iran's integrated health care system (SIB); then during a phone call, the required information in was registered in a checklist. Out of 969 pregnant women, after checking the inclusion and exclusion criteria, only 610 subjects were included in the study. Out of this number, 330 had not been vaccinated, while the rest had received inactivated COVID-19 vaccine before or during pregnancy. The maternal and neonatal outcomes were compared between vaccinated and unvaccinated women. The data were analyzed using SPSS 26 software and one-way analysis of variance (One-way ANOVA), Tukey multiple comparison, Fisher's exact test or Chi-square test, and multiple logistic regression. Results The results of this study revealed that vaccination against COVID-19 in pregnant women significantly increased the probability of jaundice in the neonate (P < 0.05), but the miscarriage rate in these women was significantly lower (P < 0.05). No adverse outcomes were observed such as high blood pressure, gestational diabetes, maternal hospitalization, maternal infection with COVID-19, premature delivery, premature rupture of the amniotic sac, perinatal death, admission to the neonatal intensive care unit, and low birth weight. Conclusions COVID-19 vaccination among pregnant women is recommended to prevent from adverse neonatal and maternal outcomes. COVID-19 vaccination neonatal and maternal outcomes miscarriage neonatal jaundice pregnant women Figures Figure 1 Background Acute respiratory syndrome coronavirus 2 (SARS-COV-2) 1 is a type of pandemic-inducing coronavirus that, like the other two members of this family, MERS-COV and SARS-COV, belongs to beta-coronavirus species ( 1 ). Pregnancy is one of the most important stages of a woman's life ( 2 , 3 ), and the physiological changes during this period have a significant impact on the immune system. Through reducing the capacity of the lungs, the mother becomes susceptible to lung infection or pneumonia, and as such it is natural that the risk of lung infection grows with the presence of SARS-COV-2. This is because with the weakening of the immune system, the mother would become more susceptible to the infection of COVID-19 ( 1 , 4 – 9 ). Since pregnant women were at risk of severe COVID-19 disease, compared to non-pregnant women of childbearing age, they were more likely to be admitted to the ICU 1 , receive invasive ventilation (such as endotracheal intubation and ECMO 3 ) and lost their lives ( 10 – 12 ). According to studies, COVID-19 in pregnancy was associated with an increased risk of pregnancy-specific complications such as pre-eclampsia, premature birth, cesarean section, and stillbirth ( 10 , 11 , 13 – 19 ). Meanwhile, the medical treatment of COVID-19 in pregnancy faced threatening challenges due to the presence of the fetus and placenta ( 5 ), and at the same time, pregnant women were often absent in the experimental vaccination populations ( 20 ). Considering the lack of an effective and efficient medicine for the treatment of COVID-19, it seemed that the vaccine was the only hope to save the world from the pandemic ( 21 ). However, due to the lack of sufficient information on the consequences of vaccination in pregnant women, pregnant women were excluded at the start of vaccination against COVID-19 ( 20 ). The epidemic of COVID-19 urgently required the development of vaccine strategies optimized for pregnant women and their babies, since both populations were at risk of severe disease ( 12 , 22 , 23 ). Also, considering the vulnerability of this group, infection with COVID-19 could be associated with a high rate of mortality in these people, so pregnant women were also included in the vaccination program ( 24 ). As of July 2021, 184 preclinical, 105 clinical, and 18 emergency use vaccines had been approved by at least one regulatory authority ( 25 ). Most of the vaccines were protein subunit (PS) vaccines, which are also called peptide vaccines. Ribonucleic acid (RNA) vaccines have also become popular, together with inactivated viral (IV), non-replicating viral vector (VVnr), deoxyribonucleic acid (DNA), and recombinant protein vaccines. Inactivated vaccines contain viruses whose genetic material has been degraded using heat, chemicals, or radiation. Thus, they cannot infect cells and replicate, yet they can still stimulate an immune response. Sinopharm vaccine has been created using this technology ( 25 , 26 ). Vaccines made from inactivated virus, such as Sinopharm, have been the most widely used COVID-19 vaccines in the world ( 26 ). In Scotland, a study indicated that the rate of infection with COVID-19 in pregnancy has a pattern similar to that of women of reproductive age. The highest rate of COVID-19 infection was observed in pregnant women compared to older women, in disadvantaged areas and younger women. In this study, by examining three vaccines, Pfizer, Moderna, and AstraZeneca, they reported that all perinatal deaths had occurred in unvaccinated women with COVID-19 ( 11 ). A study in the country Israel investigated the outcomes of the Pfizer vaccine. In this study, the vaccine was not associated with adverse maternal and neonatal outcomes, but the risk of amniotic fluid contamination with meconium had been reduced in the vaccinated group ( 27 ). In a systematic review study seeking to examine perinatal outcomes following COVID-19 vaccination, no increase in outcomes was observed and the rate of stillbirths was significantly reduced ( 28 ). The COVID-19 vaccination program in Iran for pregnant mothers started in August 2021 with Sinopharm vaccine. In this program, first, pregnant mothers over 18 years of age and after 12 weeks of pregnancy were targeted, and vaccination was prioritized in women with a gestational age of 28 weeks and more. In the revised guidelines in December 2021, there was no contraindication for injecting vaccination in the first 12 weeks of pregnancy nor for injecting the second round of AstraZeneca vaccine for people who had the first round of AstraZeneca before pregnancy or at the beginning of pregnancy due to an unplanned pregnancy ( 29 ). Although many studies have been conducted on the impact of the COVID-19 disease on pregnancy outcomes ( 3 , 5 , 30 – 32 ), there are very limited studies on the effect of the vaccine on maternal and neonatal outcomes. Due to the lack of accurate and complete information as well as very few Iranian studies in this field, together with the different vaccines used in the studies on the effect of vaccination of pregnant women against COVID-19 on maternal and newborn outcomes in other countries (they have measured Pfizer and Moderna vaccines which are based on Messenger RNA (mRNA 4 ) technology), this study was conducted to compare the maternal and neonatal outcomes of COVID-19 vaccine among pregnant women in two groups of women, vaccinated and unvaccinated, in order to help resolve the current ambiguities. Implementation This study was a retrospective cohort study starting in 2023 in Rafsanjan city, which was registered with the ethics code IR.RUMS.REC.1402.064 once the project was approved by the Research Committee of Rafsanjan University of Medical Sciences. After presenting the letter of introduction to the researcher, first through the Integrated Health System of Iran (SIB) in Rafsanjan city, contact information, job, education, history of vaccination against COVID-19, being Iranian or non-Iranian, and LMP 5 were extracted within a period of 6 months (22nd June 2021–21 December 2021). The initial number of people in this sampling was 969 subjects (Fig. 1 ). During a phone call with the samples, after introducing and stating the purpose of the study and assuring the confidentiality of the information, checking the entry criteria, and obtaining informed consent, checklist questions were asked from the mothers. Those who did not respond to the first call were sent an SMS containing the introduction of the researcher and the purpose of the study, and were contacted again. If the person did not answer his or her phone call, they would be excluded from the study. Due to not remembering the exact date of vaccination or vaccine injection during pregnancy or before and after it, as well as the type of vaccine injected, these cases were checked from the SIB system. Also, in cases where their LMP did not match the gestational age at the time of delivery as stated by the mother, the first recorded ultrasound of the pregnant mother was checked in the system. In the end, once the calls were completed, we had a sample of 610 with complete data. Next, the pregnant mothers were divided into two groups, vaccinated and unvaccinated based on vaccination or non-vaccination, where the subjects of both groups were numbered, and the final information of each person was entered into SPSS 26 program. Finally, maternal and neonatal outcomes (blood pressure disorders, gestational diabetes, hospitalization of mothers, contracting COVID-19, premature rupture of the amniotic sac, premature birth, cesarean section, abortion, maternal death, stillbirth, perinatal mortality, low birth weight, jaundice, hospitalization in NICU, and sepsis) in these two groups were compared with each other according to the type, number of vaccine doses, and time of vaccination in pregnancy. One-way ANOVA was employed to explore the relationship between age and vaccination type, while Fisher's exact test was utilized to investigate the relationship between occupation plus education level and vaccination type. In order to evaluate the relationship between the type of vaccination, the number of doses of the vaccine, as well as the time of vaccination and maternal outcomes (type of delivery, abortion, hospitalization, infection with COVID-19, blood pressure disorders, gestational diabetes, premature delivery, and premature rupture of the amniotic sac) and neonatal outcomes (perinatal mortality, NICU admission, jaundice, and low birth weight), multiple logistic regression was applied, and the effect of confounding variables was also adjusted. The results of logistic regression analysis were presented in the form of odds ratio (OR) and 95% confidence interval, and P value less than 0.05 was considered significant. Results In the present study, which was conducted on 610 mothers, the mean and standard deviation of the age of the referring pregnant women was 29.99 ± 5.47 years with an age range of 16 to 44 years. The education level of the majority of the samples (52.6%) was higher than diploma; 89 subjects (14.6%) were below diploma, 171 people (28%) had diploma, and 29 people (4.8%) had not been registered. Also, 427 people (70%) were housewives, 77 people (12.6%) were employed, and the jobs of 106 people (17.4%) had not been registered (Table 1 ). The results of the present study indicated that more than half of the pregnant women who referred to the comprehensive health centers of Rafsanjan city in 2021 did not receive any vaccine at all. Most of the vaccinated women received Sinopharm. Less than one third of the investigated women received at least one dose of the vaccine in the first trimester of pregnancy. Among the people admitted to the hospital, which was only 15% of the total number of mothers, 2% were hospitalized due to COVID-19. The most common neonatal outcome observed in more than half of the deliveries was neonatal jaundice. Perinatal mortality was observed in less than 7% cases. There were no cases of maternal death and only one case of sepsis was observed. As reported in Table 1 , one-way analysis of variance revealed that the mean age of pregnant women in terms of the number of vaccine doses during pregnancy has a statistically significant difference from each other (P < 0.001), so that the test Tukey's multiple comparisons test revealed that the mean age of women who received three doses of vaccine during pregnancy has been significantly higher than the mean age of other women (P < 0.05). As outlined in Table 1 , the groups shown with distinct English letters have a statistically significant difference in the mean age (P < 0.05). Table 1 The relationship between the demographic characteristics of age, occupation, as well as education level and the number of vaccination doses during pregnancy in pregnant women referring to comprehensive health service centers (n-610) The number of vaccine Variable Unvaccinated** (n-364) One dose (n-91) Two dose (n-139) Three dose (n-16) Statistical test statistic P value Age (years) 29.26 ± 5.34 a 30.66 ± 5.49 a 30.91 ± 5.41 a 34.94 ± 5.20 b 8.593 < 0.001* Job Housewife Employed Not registered 258 (70.9) 41 (11.3) 65 (17.9) 62 (68.1) 8 (8.8) 21 (23.1) 94 (67.6) 26 (18.7) 19 (13.7) 13 (81.3) 2 (12.5) 1 (6.3) 10.141 0.119 † Education level Under diploma Diploma Above diploma Not registered 45 (12.4) 107 (29.4) 192 (52.7) 20 (5.5) 18 (19.8) 27 (29.7) 41 (45.1) 5 (5.5) 23 (16.5) 33 (23.7) 80 (57.6) 3 (2.2) 3 (18.8) 4 (25.0) 8 (50.0) 1 (6.3) 9.414 0.400 †† The data in the table are reported as "standard deviation ± mean" for quantitative variables and as "(percentage) number" for qualitative variables. * One-way analysis of variance, ** includes unvaccinated and pre-pregnancy vaccine. † Chi-square test, †† Fisher's exact test According to the study results, with regards to maternal outcomes, there was no statistically significant relationship between the type of vaccination, the number of vaccine doses, as well as the time of vaccination and blood pressure disorders, premature birth, cesarean section, contracting COVID-19, diabetes, premature rupture of the amniotic sac, and hospitalization in the hospital during pregnancy (P < 0.05) (The tables are in the additional file). According to Table 2 , the relationship between the type of vaccination and miscarriage in the investigated women is statistically significant (P = 0.003); the women who received the Sinopharm vaccine, when compared to the women who did not receive the vaccine, had a significantly lower chance of miscarriage (since the confidence interval established for the Sinopharm odds ratio does not cover the number 1). Also, the relationship between the number of vaccine doses in pregnancy and miscarriage in the examined women is statistically significant (P = 0.019); the women who received two doses of the vaccine in pregnancy, as compared to unvaccinated women, had a significantly lower chance of miscarriage. In addition, the relationship between the time of vaccination in pregnancy and miscarriage in the investigated women is statistically significant (P = 0.031); women who received at least one dose in the second trimester of pregnancy, when compared to unvaccinated women, had a significantly lower chance of miscarriage. In other words, receiving Sinopharm vaccine during pregnancy, receiving two doses of vaccine during pregnancy, and receiving at least one dose in the second trimester of pregnancy significantly lowered the chance of miscarriage (P < 0.05). Table 2 The relationship between the type of vaccination, the number of vaccine doses, as well as the time of vaccination and miscarriage in pregnant women referring to comprehensive health service centers (n-610) Miscarriage Variable Not occurred occurred Odds ratio* (confidence interval 95%) P value vaccination type Unvaccinated (n-330) Sinopharm (n-225) Other vaccines (n-21) Pre-pregnancy vaccine (n-34) 291 (88.8) 213 (94.7) 20 (95.2) 27 (79.4) 39 (11.8) 12 (5.3) 4 (4.8) 7 (20.6) 1.000 0.376 (0.188–0.750) 0.320 (0.041–2.491) 2.266 (0.899–5.712) 0.003 number of vaccine doses during pregnancy Unvaccinated (n-364) One dose (n-91) Two dose (n-139) Three dose (n-16) 318 (87.4) 79 (86.8) 138 (99.3) 16 (100) 46 (12.6) 12 (13.2) 1 (0.7) 0 1.000 1.022 (0.505–2.070) 0.041 (0.005–0.301) - 0.019 timing of vaccination during pregnancy Unvaccinated (n-364) At least one dose in the first trimester (n-102) At least one dose in the second trimester (n-120) At least one dose in the third trimester (n-24) 318 (87.4) 90 (88.2) 119 (99.2) 24 (100) 46 (12.6) 12 (11.8) 1 (0.8) 0 1.000 0.818 (0.407–1.643) 0.048 (0.006–0.359) - 0.031 * Multiple logistic regression analysis. In calculating the odds ratio and 95% confidence interval, the effect of the confounding variables "history of pregnancy outcomes", "underlying disease", and "number of miscarriage history" has been adjusted. ** Including: Elective abortion, spontaneous abortion, and these categories were aggregated with each other in order to use logistic regression. Regarding neonatal outcomes, no statistically significant relationship was observed between the type of vaccination, the number of vaccine doses, as well as the time of vaccination and perinatal mortality, low birth weight, and admission to the NICU (P < 0.05) (The tables are in the additional file). Based on Table 3 , the relationship between the type of vaccination and the outcome of neonatal jaundice in the investigated women is statistically significant (P = 0.048); the women who received the Sinopharm vaccine compared to the women who did not receive the vaccine, had a significantly higher chance of neonatal jaundice (since the confidence interval established for the Sinopharm odds ratio does not cover the number 1). Also, the relationship between the number of vaccine doses in pregnancy and the outcome of neonatal jaundice in the examined women is statistically significant (P = 0.021); the women who received two doses of the vaccine in pregnancy and compared to unvaccinated women, had a significantly higher chance of neonatal jaundice. In addition, the relationship between the time of vaccination in pregnancy and the outcome of neonatal jaundice in the examined women is statistically significant (P = 0.003); the women who received at least one dose in the second trimester of pregnancy or at least one dose in the third trimester of pregnancy had a significantly higher chance of neonatal jaundice than women who did not receive the vaccine. In other words, receiving Sinopharm vaccine during pregnancy, receiving two doses of vaccine during pregnancy, receiving at least one dose in the second trimester of pregnancy, and receiving at least one dose in the third trimester of pregnancy would significantly increase the chance of neonatal jaundice outcome (P < 0.05). Table 3 The relationship between the type of vaccination, the number of vaccine doses, as well as the time of vaccination and neonatal jaundice in pregnant women referring to comprehensive health service centers (n-610) Neonatal jaundice Variable Not occurred occurred Odds ratio* (confidence interval 95%) P value vaccination type Unvaccinated (n-330) Sinopharm (n-225) Other vaccines (n-21) Pre-pregnancy vaccine (n-34) 172 (52.1) 92 (40.9) 9 (42.9) 17 (50.0) 158 (47.9) 133 (59.1) 12 (57.1) 17 (50.0) 1.000 1.680 (1.165–2.422) 1.482 (0.583–3.767) 1.322 (0.632–2.766) 0.048 number of vaccine doses during pregnancy Unvaccinated (n-364) One dose (n-91) Two dose (n-139) Three dose (n-16) 189 (51.9) 44 (48.4) 50 (36.0) 7 (43.8) 175 (48.1) 47 (51.6) 89 (64.0) 9 (56.3) 1.000 1.234 (0.764–1.995) 1.958 (1.274–3.008) 1.685 (0.578–4.916) 0.021 timing of vaccination during pregnancy Unvaccinated (n-364) At least one dose in the first trimester (n-102) At least one dose in the second trimester (n-120) At least one dose in the third trimester (n-24) 189 (51.9) 51 (50.0) 43 (35.8) 7 (29.2) 175 (48.1) 51 (50.0) 77 (64.2) 17 (70.8) 1.000 1.083 (0.681–1.724) 1.993 (1.266–3.136) 3.562 (1.373–9.240) 0.003 * Multiple logistic regression analysis. In calculating the odds ratio and 95% confidence interval, the effect of the confounding variables "history of pregnancy outcomes", "history of neonatal outcomes", and "underlying disease" has been adjusted. Note that in pregnant women referring to comprehensive health service centers in Rafsanjan city in 2021 (n = 610), there was no "maternal death" and only one case of "sepsis" occurred; therefore, it was not possible to examine the relationship between the type of vaccination, the number of vaccine doses, as well as the time of vaccination and the outcomes of maternal mortality and sepsis. Discussion In this study, which was conducted with the aim of comparing maternal and newborn outcomes in vaccinated and unvaccinated pregnant women against COVID-19, based on the results obtained, pregnant women who received COVID-19 vaccine had reduced risk of miscarriage compared to unvaccinated women. However, in other related studies, no such relationship has been reported regarding vaccination against COVID-19 in pregnant women, and the results have only indicated no increase in miscarriage in vaccinated pregnant women compared to non-vaccinated women ( 28 , 33 , 34 ). It seems that the findings are limited to examine this discrepancy, and there is probably a need to conduct further studies on the Sinopharm vaccine with a larger sample size, such as capturing the majority of pregnant people across the country. In our study, mild neonatal jaundice had increased in pregnant women vaccinated against COVID-19, while the study of Rottenstreich et al. (2021) indicated a reduction in hyperbilirubinemia in infants of mothers who received COVID-19 vaccine ( 35 ). It seems that the type of vaccine used in the mentioned study (Pfizer with mRNA technology), the larger sample size, and the difference in race and geographic region are probably the reasons behind the discrepancy in the results of this outcome. Nevertheless, in the study by Minghui Li et al. (2022), neonatal jaundice was increased in pregnant women who were vaccinated against COVID-19 compared to unvaccinated pregnant women ( 36 ). This result is similar to the finding of our study, which is probably due to the investigation of inactivated vaccines similar to our study. According to the results of our study, blood pressure disorders in pregnancy and gestational diabetes in pregnant women vaccinated against COVID-19 were not different compared to women who were not vaccinated against COVID-19. This is similar to a systematic review study by Rahmati et al. (2023) and the study by Süt et al in spite of examining COVID-19 vaccines made via mRNA technology. Probably, vaccination generally and with any platform can help prevent the increase of these complications ( 33 , 34 ). Based on the findings of our study, premature rupture of the amniotic sac and premature delivery were not associated with an increase among pregnant women vaccinated against COVID-19 compared to non-vaccinated pregnant women. In the results of the study by Süt et al. (2024) and the study by Minghui Li et al. (2022), vaccination against COVID-19 has again been associated with no increase in premature rupture of the amniotic sac and premature delivery, compared to unvaccinated women ( 34 , 36 ). In the first study, mRNA platform vaccines were used while in the second study, inactivated vaccines were employed. Nevertheless, in the results of the systematic review study by Shafiee et al. (2023) as well as in the review study by Rahmati et al. (2023) they had noted diminished premature delivery among mothers vaccinated against COVID-19, as compared to unvaccinated pregnant mothers ( 33 , 37 ). This discrepancy is probably due to the large sample size of these studies (at least 10 times larger than our sample size) and the type of vaccine investigated. However, according to the results of Hatami et al.'s (2024) study, premature delivery increased in pregnant mothers who were vaccinated in the first trimester compared to non-vaccinated mothers ( 38 ). According to the results obtained in our study, there was no increase in the rate of hospitalization of mothers and infection with COVID-19 in people who were vaccinated by COVID-19 vaccine compared to mothers who were not vaccinated. This result is contrary to the study of Favre et al. (2023) regarding the effect of not being vaccinated on the increase in the hospitalization rate of mothers ( 39 ). However, it is in line with the results of a review study by Prasad et al. (2022) in which vaccination in pregnant women was associated with no increase in maternal hospitalization ( 28 ). In a contradictory study, the increase in hospitalization of mothers had happened before the outbreak of the delta variant, while our study and the study in line with ours considered the time range of the outbreak of the delta variant. The results of our study also revealed that vaccination against COVID-19 in pregnant women was not associated with a difference in terms of caesarean section and maternal death. Similarly, the systematic review study by Rahmati et al. (2023) also reported no increase in cesarean section in vaccinated pregnant women compared to non-vaccinated mothers ( 33 ). The result of the study by Prasad et al. (2022) indicated no increase in maternal mortality in pregnant women who were vaccinated against COVID-19 compared to unvaccinated pregnant women ( 28 ). This lack of increase in the mentioned outcomes can be due to the importance of vaccination against COVID-19, regardless of the type of vaccine. In the results obtained from our study, vaccination against COVID-19 in pregnant women did not change the rate of perinatal mortality and stillbirth, while in the study of Stock et al. (2022) all cases of perinatal mortality occurred only in unvaccinated pregnant women infected with COVID-19 [12]. In the study of Schwarts et al. (2023), the risk of stillbirth was mentioned only in pregnant women who were not vaccinated against COVID-19 ( 40 ). Also, the results of two review studies by Prasad et al. (2022) and the study by Rahmati et al. (2023) indicated a reduction in the risk of stillbirth in pregnant women vaccinated against COVID-19 compared to pregnant women who were not vaccinated against COVID-19 ( 28 , 33 ). These results were contrary to our findings. In these studies, in most of the cases, the utilized vaccine was the mRNA platform, while the result observed in our study was obtained from the investigation of the inactivated vaccine (36.9% of cases being Sinopharm). In the present study, neonatal outcomes such as low birth weight, NICU admission, and sepsis were not different either in pregnant women who were vaccinated against COVID-19 compared to unvaccinated pregnant mothers. These results were in line with other related studies which pointed to the lack of low birth weight and admission to the NICU ( 28 , 33 , 34 , 41 ). Regarding sepsis, no similar study was found that had investigated this outcome in these two groups of women. One of the limitations of our study was the lack of accurate recording of all maternal and neonatal outcomes in the SIB system, and as a result, the loss of a number of samples, as well as the lack of access to the information of mothers who did not respond to their phone calls. The strength of our study was the direct communication with the mothers themselves; we were able to receive and record all the necessary information from them. It is suggested that this study be investigated in a larger statistical population to explore long-term maternal and neonatal outcomes. Conclusion The results of this study indicated that the COVID-19 vaccination (inactivated vaccines) in pregnant women was not associated with any special complication that would increase an outcome. Only the chance of newborn jaundice increased, though the neonatal jaundice was of a mild type and these babies did not need to be hospitalized. It seems that in order to obtain more accurate results, there is a need to conduct studies with a larger sample size and compare different types of vaccines. Abbreviations SARS-COV-2: The virus that causes the disease known as coronavirus disease 2019 ICU: Intensive Care Unit ECMO: Extra-corporal membrane oxygenation mRNA: Messenger RNA LMP: Last menstrual period Declarations Consent to participate and for publication: Informed Consent Form Informed Consent for Participation in Research Study Rafsanjan University of Medical Sciences Title of Research Project Comparing the maternal and neonatal outcomes in vaccinated and unvaccinated pregnant women against COVID-19: a retrospective cohort study Name(s) of Researcher(s) Zahra Gholami, Maryam Mohseni, Pouran Allahbakhshi Nasab Relevant Faculty or Unit Faculty of Nursing and Midwifery, Midwifery Group Introduction to the Research In this descriptive comparative study, contact information for pregnant mothers will initially be extracted from the Integrated Health System of Iran (SIB). Subsequently, the researcher will complete a checklist through a phone call after obtaining the mother's consent. The research sample includes women whose pregnancies began during the first six months of the COVID-19 vaccination rollout (from July 22, 2021, to December 21, 2021). Pregnant mothers will be divided into two groups based on whether or not they received the vaccine during pregnancy: vaccinated and unvaccinated. Maternal and neonatal outcomes in these two groups will be compared. The number of doses, type, and timing of vaccine administration will be queried in the questionnaire and will be taken into account during the analysis. Benefits This research does not provide direct benefits to participants, but participation may enhance the awareness and knowledge of healthcare workers and the community in this area. Side Effects This study has no associated side effects. Costs Related to Conducting the Research Project The costs of this study will be borne by the researcher, and participants will not incur any expenses Confidentiality: Results from the checklist and methodology will be communicated to the participants and will be used strictly for research purposes. Information regarding the participants will remain confidential within the bounds of the law, society, and family. Responding to Questions: The researcher will respond any questions related to the project through the following contact number: +98 916 870 2600 Right to Refuse or Withdraw Information will be gathered through phone calls with mothers, and responding to the checklist questions will be optional and voluntary Consent (in full awareness and stress-free conditions): Based on the information contained in this form and the explanations provided by the researcher or their colleagues, I hereby express my agreement to participate in this study. Availability of data and materials: The data that support the findings of this study are available from Zahra Gholami but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of Zahra Gholami. However, the data is organized in such a way that each individual is assigned a number, and then the checklist information for that individual is recorded in an SPSS file. Competing interests The authors declare that they have no competing interests. Funding Not applicable. Authors' contributions Z GH: design of the work, have drafted the work, writing the text of the article and sampling M M: design of the work, review and correction of the text of the article, advice on sampling, statistical analysis (corresponding author) P AN: Reviewing and correcting the text of the article, Advice on designing the work, Completing the initial SPSS file for analysis Clinical Trial: Not applicable Clinical train number: Not applicable Acknowledgements Not applicable Authors' information Zahra Gholami 1 , Maryam Mohseni 2* , Pouran Allahbakhshi Nasab 3 1. Master's in Midwifery, Dept. of midwifery, School of Nursing and Midwifery, Rafsanjan University of Medical Sciences, Rafsanjan, Iran E-mail: [email protected] 2. PhD in reproductive health, Associate Professor, Dept. of Midwifery, School of Nursing and Midwifery, Geriatric Care Research Center, Rafsanjan University of Medical Sciences, Rafsanjan, Iran *(Corresponding author) E-mail: [email protected] 3. Master's in Midwifery, Instructor, Dept. of Midwifery, School of Nursing and Midwifery, Geriatric Care Research Center, Rafsanjan University of Medical Sciences, Rafsanjan, Iran E-mail: [email protected] *. Corresponding author: Maryam Mohseni References Alavian F, Alavian K, Pregnancy. COVID-19: physiology, some challenges, and solutions. Iran J Obstet Gynecol Infertility. 2021;24(1):99–111. Abedzadeh-Kalahroudi M, Karimian Z, Nasiri S, Khorshidifard MS. Anxiety and perceived stress of pregnant women towards Covid-19 disease and its related factors in Kashan (2020). Iran J Obstet Gynecol Infertility. 2021;24(5):8–18. Marshall JE, Raynor MD. Myles' Textbook for Midwives E-Book: Myles' Textbook for Midwives E-Book. Elsevier Health Sciences; 2014. Zhao X, Jiang Y, Zhao Y, Xi H, Liu C, Qu F, et al. Analysis of the susceptibility to COVID-19 in pregnancy and recommendations on potential drug screening. Eur J Clin Microbiol Infect Dis. 2020;39:1209–20. Fan C, Lei D, Fang C, Li C, Wang M, Liu Y, et al. Perinatal transmission of 2019 coronavirus disease–associated severe acute respiratory syndrome coronavirus 2: should we worry? Clin Infect Dis. 2021;72(5):862–4. Jahanbakhsh SS, Taghavi Gilani M, Hashemian A, Rais Assadat B. Review of cardiopulmonary resuscitation in pregnant Women. Iran J Obstet Gynecol Infertility. 2007;10(2):87–96. Rajabzadeh R, Hamid Hoseini S, Rezazadeh J, Baghban A, Nasiri M, Hosein Ayati M. Prevalence of anemia and its related factors in pregnant women referring to health centers of Mane and Samalghan city. Iran J Obstet Gynecol Infertility. 2015;18(171):1–7. Fazeli E, Tafazzoli M, Dadgar S, Seyed Ahmadinezhad F. The role of carbohydrates and dietary energy intake in functional ovarian cysts. Iran J Obstet Gynecol Infertility. 2015;18(152):9–15. Goodnight WH, Soper DE. Pneumonia in pregnancy. Crit Care Med. 2005;33(10):S390–7. Stock SJ, Carruthers J, Calvert C, Denny C, Donaghy J, Goulding A, et al. SARS-CoV-2 infection and COVID-19 vaccination rates in pregnant women in Scotland. Nat Med. 2022;28(3):504–12. Allotey J, Fernandez S, Bonet M, Stallings E, Yap M, Kew T et al. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. 2020;370. Zambrano LD. Update: characteristics of symptomatic women of reproductive age with laboratory-confirmed SARS-CoV-2 infection by pregnancy status—United States, January 22–October 3, 2020. MMWR Morbidity and mortality weekly report. 2020;69. Uptodate. COVID-19: Overview of pregnancy issues https://www3.utdos.ir/contents/search?search=covid19%20in%20pregnancy&sp=0&searchType=PLAIN_TEXT&source=USER_INPUT &searchControl=TOP_PULLDOWN&searchOffset=1&autoComplete=false&language=en &max=10&index=&autoCompleteTerm=20222022[ Villar J, Ariff S, Gunier RB, Thiruvengadam R, Rauch S, Kholin A, et al. Maternal and neonatal morbidity and mortality among pregnant women with and without COVID-19 infection: the INTERCOVID multinational cohort study. JAMA Pediatr. 2021;175(8):817–26. Papageorghiou AT, Deruelle P, Gunier RB, Rauch S, García-May PK, Mhatre M, et al. Preeclampsia and COVID-19: results from the INTERCOVID prospective longitudinal study. Am J Obstet Gynecol. 2021;225(3):289. e1-. e17. Wei SQ, Bilodeau-Bertrand M, Liu S, Auger N. The impact of COVID-19 on pregnancy outcomes: a systematic review and meta-analysis. CMAJ. 2021;193(16):E540–8. Knight M, Bunch K, Vousden N, Morris E, Simpson N, Gale C et al. Characteristics and outcomes of pregnant women admitted to hospital with confirmed SARS-CoV-2 infection in UK: national population based cohort study. BMJ. 2020;369. Vousden N, Bunch K, Morris E, Simpson N, Gale C, O’Brien P, et al. The incidence, characteristics and outcomes of pregnant women hospitalized with symptomatic and asymptomatic SARS-CoV-2 infection in the UK from March to September 2020: a national cohort study using the UK Obstetric Surveillance System (UKOSS). PLoS ONE. 2021;16(5):e0251123. Mullins E, Hudak ML, Banerjee J, Getzlaff T, Townson J, Barnette K, et al. Pregnancy and neonatal outcomes of COVID-19: coreporting of common outcomes from PAN‐COVID and AAP‐SONPM registries. Ultrasound Obstet Gynecol. 2021;57(4):573–81. Di Mascio D, Khalil A, Saccone G, Rizzo G, Buca D, Liberati M, et al. Outcome of coronavirus spectrum infections (SARS, MERS, COVID-19) during pregnancy: a systematic review and meta-analysis. Am J Obstet Gynecol MFM. 2020;2(2):100107. Kudlay D, Svistunov A. COVID-19 vaccines: an overview of different platforms. Bioengineering. 2022;9(2):72. Shook LL, Fallah PN, Silberman JN, Edlow AG. COVID-19 vaccination in pregnancy and lactation: current research and gaps in understanding. Front Cell Infect Microbiol. 2021;11:735394. Woodworth KR. Birth and infant outcomes following laboratory-confirmed SARS-CoV-2 infection in pregnancy—SET-NET, 16 jurisdictions, March 29–October 14, 2020. MMWR Morbidity and Mortality Weekly Report. 2020;69. Sabouni M. govazi s. COVID-19 vaccination in pregnant women. Behvarz Quarterly. 2022;33(112):44 – 8. Ndwandwe D, Wiysonge CS. COVID-19 vaccines. Curr Opin Immunol. 2021;71:111–6. Mouro V, Fischer A. Dealing with a mucosal viral pandemic: lessons from COVID-19 vaccines. Mucosal Immunol. 2022;15(4):584–94. Peretz-Machluf R, Hirsh-Yechezkel G, Zaslavsky-Paltiel I, Farhi A, Avisar N, Lerner-Geva L, et al. Obstetric and neonatal outcomes following COVID-19 vaccination in pregnancy. J Clin Med. 2022;11(9):2540. Prasad S, Kalafat E, Blakeway H, Townsend R, O’Brien P, Morris E, et al. Systematic review and meta-analysis of the effectiveness and perinatal outcomes of COVID-19 vaccination in pregnancy. Nat Commun. 2022;13(1):1–8. MoHaMTo I. covid-19 vaccination in pregnancy https://shc.sbmu.ac.ir/uploads/205/%D8%A8%D9%87%D8%AF%D8%A7%D8%B4%D8%AA%20%D8%AE%D8%A7% D9%86%D9%88%D8%A7%D8%AF%D9%87/%D9%85%D8%A7%D8% AF%D8%B1%D8%A7%D9%86/%D8%AF%D8% B3%D8%AA%D9%88%D8%B1%D8%A7%D9%84%D8%B9%D9%85%D9%84%20%D9%85%D8%A7%D8%AF%D8% B1%D8%A7%D9%86%20%D8%A8%D8%A7%D8%B1%D8%AF%D8%A7%D8%B1%20%D8%AF%D8%B1%20% DA%A9%D8%B1%D9%88%D9%86%D8%A7/%D8%A2% D8%AE%D8%B1%DB%8C%D9%86%20%D8%AF%D8%B3%D8%AA%D9%88%D8%B1%D8%A7%D9%84%D8%B9% D9%85%D9%84%20%D9%88%D8%A7%DA%A9% D8%B3%D9%86%20%DA%A9%D9%88%D9%88%DB%8C%D8%AF_1.pdf20212021 [. Moaya M, Shahali S, Farhoudi B. Maternal and neonatal outcomes of pregnant women with COVID-19 in Amir-al-momenin hospital during March to May 2020. Iran J Obstet Gynecol Infertility. 2020;23(9):35–42. Fayazi M, Rahmani R, Bilandi RR. Clinical manifestations, maternal, fetal and neonatal outcomes in pregnant women with COVID-19: a systematic review. 2021. Karimi L, Makvandi S, Vahedian-Azimi A, Sathyapalan T, Sahebkar A. Effect of COVID-19 on mortality of pregnant and postpartum women: a systematic review and meta‐analysis. J pregnancy. 2021;2021(1):8870129. Rahmati M, Yon DK, Lee SW, Butler L, Koyanagi A, Jacob L, et al. Effects of COVID-19 vaccination during pregnancy on SARS‐CoV‐2 infection and maternal and neonatal outcomes: A systematic review and meta‐analysis. Rev Med Virol. 2023;33(3):e2434. Süt H, Yıldız GA, Şeker E, Ümit C, Koçar M, Koç A. Maternal and perinatal outcomes of COVID-19 vaccination during pregnancy. J Turkish German Gynecol Association. 2023;24(2):120. Rottenstreich M, Sela H, Rotem R, Kadish E, Wiener-Well Y, Grisaru‐Granovsky S. Covid‐19 vaccination during the third trimester of pregnancy: rate of vaccination and maternal and neonatal outcomes, a multicentre retrospective cohort study. BJOG: Int J Obstet Gynecol. 2022;129(2):248–55. Li M, Hao J, Jiang T, Deng W, Lu H, Wang S, et al. Maternal and neonatal safety of COVID-19 vaccination during the peri‐pregnancy period: a prospective study. J Med Virol. 2023;95(1):e28378. Shafiee A, Kohandel Gargari O, Teymouri Athar MM, Fathi H, Ghaemi M, Mozhgani S-H. COVID-19 vaccination during pregnancy: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2023;23(1):45. Hatami D, Habibelahi A, Changizi N, Heidarzadeh M, Nojomi M, Rast M, et al. Perinatal outcomes and sinopharm BBIBP-CorV vaccination during pregnancy. BMC Pregnancy Childbirth. 2024;24(1):190. Favre G, Maisonneuve E, Pomar L, Daire C, Poncelet C, Quibel T et al. Maternal and perinatal outcomes following pre-Delta, Delta, and Omicron SARS-CoV-2 variants infection among unvaccinated pregnant women in France and Switzerland: a prospective cohort study using the COVI-PREG registry. Lancet Reg Health–Europe. 2023;26. Schwartz DA, Mulkey SB, Roberts DJ. SARS-CoV-2 placentitis, stillbirth, and maternal COVID-19 vaccination: clinical–pathologic correlations. Am J Obstet Gynecol. 2023;228(3):261–9. Badell ML, Dude CM, Rasmussen SA, Jamieson DJ. Covid-19 vaccination in pregnancy. BMJ. 2022;378. Footnotes The virus that causes the disease known as coronavirus disease 2019 Intensive Care Unit Extra-corporal membrane oxygenation Messenger RNA Last menstrual period Additional Declarations No competing interests reported. Supplementary Files Additionalsupportingfile.docx Cite Share Download PDF Status: Published Journal Publication published 28 Mar, 2025 Read the published version in BMC Pregnancy and Childbirth → Version 1 posted Editorial decision: Revision requested 04 Nov, 2024 Editor assigned by journal 04 Nov, 2024 Submission checks completed at journal 01 Nov, 2024 First submitted to journal 28 Oct, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5349935","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":373833854,"identity":"e2eab7bc-4220-4919-98bf-8fe1c5f2803a","order_by":0,"name":"Zahra Gholami","email":"","orcid":"","institution":"Rafsanjan University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Zahra","middleName":"","lastName":"Gholami","suffix":""},{"id":373833855,"identity":"4eb212c3-2337-4b0f-bc32-0cfbd567ccaf","order_by":1,"name":"Maryam Mohseni","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA70lEQVRIiWNgGAWjYFACHhAhwcDPzNj+4wMDQwLxWiTbmw9IziBBCwODwZljCdI8xGjRbe89/OHjDgsGhhs5Bsa2bXZ5/OwNjB8+5uDWYnbmXJrkzDMSDIwzcgySc9uSiyV7DjBLztyGR8uNHDNm3jYJBmaJHIPDuW3MiRtuJLAx8+LXYvz5L1ALm0SOYbNlWz1RWgykGYFaeHiOJTMzth0mQsuZM2aSvUAtEuzNxxh7zh1PnNlzsBm/X473GH/42VbHYH+YsY3hR1l1Yj9788EPH/FogYH6BhDJyAYmGwirR4A/pCgeBaNgFIyCkQIAohhRyi5oDX8AAAAASUVORK5CYII=","orcid":"","institution":"Rafsanjan University of Medical Sciences","correspondingAuthor":true,"prefix":"","firstName":"Maryam","middleName":"","lastName":"Mohseni","suffix":""},{"id":373833856,"identity":"cd36ea4a-b707-492c-8126-25a094465d37","order_by":2,"name":"Pouran Allahbakhshi Nasab","email":"","orcid":"","institution":"Rafsanjan University of Medical Sciences","correspondingAuthor":false,"prefix":"","firstName":"Pouran","middleName":"Allahbakhshi","lastName":"Nasab","suffix":""}],"badges":[],"createdAt":"2024-10-28 23:23:07","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5349935/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5349935/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12884-025-07462-x","type":"published","date":"2025-03-28T15:57:44+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":70038245,"identity":"5548df64-485e-4357-8b88-44f71f6354a5","added_by":"auto","created_at":"2024-11-27 17:34:14","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":45857,"visible":true,"origin":"","legend":"\u003cp\u003eSee image above for figure legend\u003c/p\u003e","description":"","filename":"fig1diagram.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-5349935/v1/239a0b6d1286ba984752de96.jpeg"},{"id":79604902,"identity":"63932b94-79b2-4440-b46f-7498a692e776","added_by":"auto","created_at":"2025-03-31 16:08:38","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1041814,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5349935/v1/708e7327-f8af-4a45-b48c-b0ab83639922.pdf"},{"id":70038246,"identity":"752c00c9-562c-4a42-803d-7b2f1f1b81e8","added_by":"auto","created_at":"2024-11-27 17:34:14","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":57751,"visible":true,"origin":"","legend":"","description":"","filename":"Additionalsupportingfile.docx","url":"https://assets-eu.researchsquare.com/files/rs-5349935/v1/06f0c840a73b486049f8c2d1.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Comparing the maternal and neonatal outcomes in vaccinated and unvaccinated pregnant women against COVID-19: a retrospective cohort study","fulltext":[{"header":"Background","content":"\u003cp\u003eAcute respiratory syndrome coronavirus 2 (SARS-COV-2)\u003csup\u003e1\u003c/sup\u003e is a type of pandemic-inducing coronavirus that, like the other two members of this family, MERS-COV and SARS-COV, belongs to beta-coronavirus species (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). Pregnancy is one of the most important stages of a woman's life (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e), and the physiological changes during this period have a significant impact on the immune system. Through reducing the capacity of the lungs, the mother becomes susceptible to lung infection or pneumonia, and as such it is natural that the risk of lung infection grows with the presence of SARS-COV-2. This is because with the weakening of the immune system, the mother would become more susceptible to the infection of COVID-19 (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan additionalcitationids=\"CR5 CR6 CR7 CR8\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). Since pregnant women were at risk of severe COVID-19 disease, compared to non-pregnant women of childbearing age, they were more likely to be admitted to the ICU\u003csup\u003e1\u003c/sup\u003e, receive invasive ventilation (such as endotracheal intubation and ECMO\u003csup\u003e3\u003c/sup\u003e) and lost their lives (\u003cspan additionalcitationids=\"CR11\" citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). According to studies, COVID-19 in pregnancy was associated with an increased risk of pregnancy-specific complications such as pre-eclampsia, premature birth, cesarean section, and stillbirth (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan additionalcitationids=\"CR14 CR15 CR16 CR17 CR18\" citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eMeanwhile, the medical treatment of COVID-19 in pregnancy faced threatening challenges due to the presence of the fetus and placenta (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e), and at the same time, pregnant women were often absent in the experimental vaccination populations (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). Considering the lack of an effective and efficient medicine for the treatment of COVID-19, it seemed that the vaccine was the only hope to save the world from the pandemic (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). However, due to the lack of sufficient information on the consequences of vaccination in pregnant women, pregnant women were excluded at the start of vaccination against COVID-19 (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). The epidemic of COVID-19 urgently required the development of vaccine strategies optimized for pregnant women and their babies, since both populations were at risk of severe disease (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e). Also, considering the vulnerability of this group, infection with COVID-19 could be associated with a high rate of mortality in these people, so pregnant women were also included in the vaccination program (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). As of July 2021, 184 preclinical, 105 clinical, and 18 emergency use vaccines had been approved by at least one regulatory authority (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e). Most of the vaccines were protein subunit (PS) vaccines, which are also called peptide vaccines. Ribonucleic acid (RNA) vaccines have also become popular, together with inactivated viral (IV), non-replicating viral vector (VVnr), deoxyribonucleic acid (DNA), and recombinant protein vaccines. Inactivated vaccines contain viruses whose genetic material has been degraded using heat, chemicals, or radiation. Thus, they cannot infect cells and replicate, yet they can still stimulate an immune response. Sinopharm vaccine has been created using this technology (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). Vaccines made from inactivated virus, such as Sinopharm, have been the most widely used COVID-19 vaccines in the world (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). In Scotland, a study indicated that the rate of infection with COVID-19 in pregnancy has a pattern similar to that of women of reproductive age. The highest rate of COVID-19 infection was observed in pregnant women compared to older women, in disadvantaged areas and younger women. In this study, by examining three vaccines, Pfizer, Moderna, and AstraZeneca, they reported that all perinatal deaths had occurred in unvaccinated women with COVID-19 (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). A study in the country Israel investigated the outcomes of the Pfizer vaccine. In this study, the vaccine was not associated with adverse maternal and neonatal outcomes, but the risk of amniotic fluid contamination with meconium had been reduced in the vaccinated group (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e). In a systematic review study seeking to examine perinatal outcomes following COVID-19 vaccination, no increase in outcomes was observed and the rate of stillbirths was significantly reduced (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe COVID-19 vaccination program in Iran for pregnant mothers started in August 2021 with Sinopharm vaccine. In this program, first, pregnant mothers over 18 years of age and after 12 weeks of pregnancy were targeted, and vaccination was prioritized in women with a gestational age of 28 weeks and more. In the revised guidelines in December 2021, there was no contraindication for injecting vaccination in the first 12 weeks of pregnancy nor for injecting the second round of AstraZeneca vaccine for people who had the first round of AstraZeneca before pregnancy or at the beginning of pregnancy due to an unplanned pregnancy (\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e). Although many studies have been conducted on the impact of the COVID-19 disease on pregnancy outcomes (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan additionalcitationids=\"CR31\" citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e), there are very limited studies on the effect of the vaccine on maternal and neonatal outcomes. Due to the lack of accurate and complete information as well as very few Iranian studies in this field, together with the different vaccines used in the studies on the effect of vaccination of pregnant women against COVID-19 on maternal and newborn outcomes in other countries (they have measured Pfizer and Moderna vaccines which are based on Messenger RNA (mRNA\u003csup\u003e4\u003c/sup\u003e) technology), this study was conducted to compare the maternal and neonatal outcomes of COVID-19 vaccine among pregnant women in two groups of women, vaccinated and unvaccinated, in order to help resolve the current ambiguities.\u003c/p\u003e"},{"header":"Implementation","content":"\u003cp\u003eThis study was a retrospective cohort study starting in 2023 in Rafsanjan city, which was registered with the ethics code IR.RUMS.REC.1402.064 once the project was approved by the Research Committee of Rafsanjan University of Medical Sciences.\u003c/p\u003e \u003cp\u003eAfter presenting the letter of introduction to the researcher, first through the Integrated Health System of Iran (SIB) in Rafsanjan city, contact information, job, education, history of vaccination against COVID-19, being Iranian or non-Iranian, and LMP\u003csup\u003e5\u003c/sup\u003e were extracted within a period of 6 months (22nd June 2021\u0026ndash;21 December 2021). The initial number of people in this sampling was 969 subjects (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). During a phone call with the samples, after introducing and stating the purpose of the study and assuring the confidentiality of the information, checking the entry criteria, and obtaining informed consent, checklist questions were asked from the mothers.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThose who did not respond to the first call were sent an SMS containing the introduction of the researcher and the purpose of the study, and were contacted again. If the person did not answer his or her phone call, they would be excluded from the study. Due to not remembering the exact date of vaccination or vaccine injection during pregnancy or before and after it, as well as the type of vaccine injected, these cases were checked from the SIB system. Also, in cases where their LMP did not match the gestational age at the time of delivery as stated by the mother, the first recorded ultrasound of the pregnant mother was checked in the system. In the end, once the calls were completed, we had a sample of 610 with complete data.\u003c/p\u003e \u003cp\u003eNext, the pregnant mothers were divided into two groups, vaccinated and unvaccinated based on vaccination or non-vaccination, where the subjects of both groups were numbered, and the final information of each person was entered into SPSS 26 program. Finally, maternal and neonatal outcomes (blood pressure disorders, gestational diabetes, hospitalization of mothers, contracting COVID-19, premature rupture of the amniotic sac, premature birth, cesarean section, abortion, maternal death, stillbirth, perinatal mortality, low birth weight, jaundice, hospitalization in NICU, and sepsis) in these two groups were compared with each other according to the type, number of vaccine doses, and time of vaccination in pregnancy.\u003c/p\u003e \u003cp\u003eOne-way ANOVA was employed to explore the relationship between age and vaccination type, while Fisher's exact test was utilized to investigate the relationship between occupation plus education level and vaccination type. In order to evaluate the relationship between the type of vaccination, the number of doses of the vaccine, as well as the time of vaccination and maternal outcomes (type of delivery, abortion, hospitalization, infection with COVID-19, blood pressure disorders, gestational diabetes, premature delivery, and premature rupture of the amniotic sac) and neonatal outcomes (perinatal mortality, NICU admission, jaundice, and low birth weight), multiple logistic regression was applied, and the effect of confounding variables was also adjusted. The results of logistic regression analysis were presented in the form of odds ratio (OR) and 95% confidence interval, and P value less than 0.05 was considered significant.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eIn the present study, which was conducted on 610 mothers, the mean and standard deviation of the age of the referring pregnant women was 29.99\u0026thinsp;\u0026plusmn;\u0026thinsp;5.47 years with an age range of 16 to 44 years. The education level of the majority of the samples (52.6%) was higher than diploma; 89 subjects (14.6%) were below diploma, 171 people (28%) had diploma, and 29 people (4.8%) had not been registered. Also, 427 people (70%) were housewives, 77 people (12.6%) were employed, and the jobs of 106 people (17.4%) had not been registered (Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eThe results of the present study indicated that more than half of the pregnant women who referred to the comprehensive health centers of Rafsanjan city in 2021 did not receive any vaccine at all. Most of the vaccinated women received Sinopharm. Less than one third of the investigated women received at least one dose of the vaccine in the first trimester of pregnancy. Among the people admitted to the hospital, which was only 15% of the total number of mothers, 2% were hospitalized due to COVID-19. The most common neonatal outcome observed in more than half of the deliveries was neonatal jaundice. Perinatal mortality was observed in less than 7% cases. There were no cases of maternal death and only one case of sepsis was observed.\u003c/p\u003e\n\u003cp\u003eAs reported in Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e, one-way analysis of variance revealed that the mean age of pregnant women in terms of the number of vaccine doses during pregnancy has a statistically significant difference from each other (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001), so that the test Tukey\u0026apos;s multiple comparisons test revealed that the mean age of women who received three doses of vaccine during pregnancy has been significantly higher than the mean age of other women (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05). As outlined in Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e, the groups shown with distinct English letters have a statistically significant difference in the mean age (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05).\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\u0026nbsp;\u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eThe relationship between the demographic characteristics of age, occupation, as well as education level and the number of vaccination doses during pregnancy in pregnant women referring to comprehensive health service centers (n-610)\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003ccolgroup cols=\"7\"\u003e\u003c/colgroup\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eThe number of vaccine\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Variable\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eUnvaccinated** (n-364)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eOne dose\u003c/p\u003e\n \u003cp\u003e(n-91)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eTwo dose\u003c/p\u003e\n \u003cp\u003e(n-139)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eThree dose\u003c/p\u003e\n \u003cp\u003e(n-16)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eStatistical test statistic\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eP value\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eAge (years)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e29.26\u0026thinsp;\u0026plusmn;\u0026thinsp;5.34\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e30.66\u0026thinsp;\u0026plusmn;\u0026thinsp;5.49 \u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e30.91\u0026thinsp;\u0026plusmn;\u0026thinsp;5.41 \u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e34.94\u0026thinsp;\u0026plusmn;\u0026thinsp;5.20 \u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e8.593\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u0026lt;\u0026thinsp;0.001*\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eJob\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eHousewife\u003c/p\u003e\n \u003cp\u003eEmployed\u003c/p\u003e\n \u003cp\u003eNot registered\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e258 (70.9)\u003c/p\u003e\n \u003cp\u003e41 (11.3)\u003c/p\u003e\n \u003cp\u003e65 (17.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e62 (68.1)\u003c/p\u003e\n \u003cp\u003e8 (8.8)\u003c/p\u003e\n \u003cp\u003e21 (23.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e94 (67.6)\u003c/p\u003e\n \u003cp\u003e26 (18.7)\u003c/p\u003e\n \u003cp\u003e19 (13.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e13 (81.3)\u003c/p\u003e\n \u003cp\u003e2 (12.5)\u003c/p\u003e\n \u003cp\u003e1 (6.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e10.141\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.119\u003csup\u003e\u0026dagger;\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eEducation level\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eUnder diploma\u003c/p\u003e\n \u003cp\u003eDiploma\u003c/p\u003e\n \u003cp\u003eAbove diploma\u003c/p\u003e\n \u003cp\u003eNot registered\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e45 (12.4)\u003c/p\u003e\n \u003cp\u003e107 (29.4)\u003c/p\u003e\n \u003cp\u003e192 (52.7)\u003c/p\u003e\n \u003cp\u003e20 (5.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e18 (19.8)\u003c/p\u003e\n \u003cp\u003e27 (29.7)\u003c/p\u003e\n \u003cp\u003e41 (45.1)\u003c/p\u003e\n \u003cp\u003e5 (5.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e23 (16.5)\u003c/p\u003e\n \u003cp\u003e33 (23.7)\u003c/p\u003e\n \u003cp\u003e80 (57.6)\u003c/p\u003e\n \u003cp\u003e3 (2.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3 (18.8)\u003c/p\u003e\n \u003cp\u003e4 (25.0)\u003c/p\u003e\n \u003cp\u003e8 (50.0)\u003c/p\u003e\n \u003cp\u003e1 (6.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e9.414\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.400\u003csup\u003e\u0026dagger;\u0026dagger;\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003eThe data in the table are reported as \u0026quot;standard deviation\u0026thinsp;\u0026plusmn;\u0026thinsp;mean\u0026quot; for quantitative variables and as \u0026quot;(percentage) number\u0026quot; for qualitative variables. * One-way analysis of variance, ** includes unvaccinated and pre-pregnancy vaccine. \u0026dagger; Chi-square test, \u0026dagger;\u0026dagger; Fisher\u0026apos;s exact test\u003c/p\u003e\n\u003cp\u003eAccording to the study results, with regards to maternal outcomes, there was no statistically significant relationship between the type of vaccination, the number of vaccine doses, as well as the time of vaccination and blood pressure disorders, premature birth, cesarean section, contracting COVID-19, diabetes, premature rupture of the amniotic sac, and hospitalization in the hospital during pregnancy (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05) (The tables are in the additional file).\u003c/p\u003e\n\u003cp\u003eAccording to Table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e, the relationship between the type of vaccination and miscarriage in the investigated women is statistically significant (P\u0026thinsp;=\u0026thinsp;0.003); the women who received the Sinopharm vaccine, when compared to the women who did not receive the vaccine, had a significantly lower chance of miscarriage (since the confidence interval established for the Sinopharm odds ratio does not cover the number 1). Also, the relationship between the number of vaccine doses in pregnancy and miscarriage in the examined women is statistically significant (P\u0026thinsp;=\u0026thinsp;0.019); the women who received two doses of the vaccine in pregnancy, as compared to unvaccinated women, had a significantly lower chance of miscarriage. In addition, the relationship between the time of vaccination in pregnancy and miscarriage in the investigated women is statistically significant (P\u0026thinsp;=\u0026thinsp;0.031); women who received at least one dose in the second trimester of pregnancy, when compared to unvaccinated women, had a significantly lower chance of miscarriage.\u003c/p\u003e\n\u003cp\u003eIn other words, receiving Sinopharm vaccine during pregnancy, receiving two doses of vaccine during pregnancy, and receiving at least one dose in the second trimester of pregnancy significantly lowered the chance of miscarriage (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05).\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\u0026nbsp;\u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eThe relationship between the type of vaccination, the number of vaccine doses, as well as the time of vaccination and miscarriage in pregnant women referring to comprehensive health service centers (n-610)\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003ccolgroup cols=\"6\"\u003e\u003c/colgroup\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eMiscarriage\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Variable\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eNot occurred\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eoccurred\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eOdds ratio* (confidence interval 95%)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eP value\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003evaccination type\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eUnvaccinated (n-330)\u003c/p\u003e\n \u003cp\u003eSinopharm (n-225)\u003c/p\u003e\n \u003cp\u003eOther vaccines (n-21)\u003c/p\u003e\n \u003cp\u003ePre-pregnancy vaccine (n-34)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e291 (88.8)\u003c/p\u003e\n \u003cp\u003e213 (94.7)\u003c/p\u003e\n \u003cp\u003e20 (95.2)\u003c/p\u003e\n \u003cp\u003e27 (79.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e39 (11.8)\u003c/p\u003e\n \u003cp\u003e12 (5.3)\u003c/p\u003e\n \u003cp\u003e4 (4.8)\u003c/p\u003e\n \u003cp\u003e7 (20.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003cp\u003e0.376 (0.188\u0026ndash;0.750)\u003c/p\u003e\n \u003cp\u003e0.320 (0.041\u0026ndash;2.491)\u003c/p\u003e\n \u003cp\u003e2.266 (0.899\u0026ndash;5.712)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.003\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003enumber of vaccine doses during pregnancy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eUnvaccinated (n-364)\u003c/p\u003e\n \u003cp\u003eOne dose (n-91)\u003c/p\u003e\n \u003cp\u003eTwo dose (n-139)\u003c/p\u003e\n \u003cp\u003eThree dose (n-16)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e318 (87.4)\u003c/p\u003e\n \u003cp\u003e79 (86.8)\u003c/p\u003e\n \u003cp\u003e138 (99.3)\u003c/p\u003e\n \u003cp\u003e16 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e46 (12.6)\u003c/p\u003e\n \u003cp\u003e12 (13.2)\u003c/p\u003e\n \u003cp\u003e1 (0.7)\u003c/p\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003cp\u003e1.022 (0.505\u0026ndash;2.070)\u003c/p\u003e\n \u003cp\u003e0.041 (0.005\u0026ndash;0.301)\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.019\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003etiming of vaccination during pregnancy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eUnvaccinated (n-364)\u003c/p\u003e\n \u003cp\u003eAt least one dose in the first trimester (n-102)\u003c/p\u003e\n \u003cp\u003eAt least one dose in the second trimester (n-120)\u003c/p\u003e\n \u003cp\u003eAt least one dose in the third trimester (n-24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e318 (87.4)\u003c/p\u003e\n \u003cp\u003e90 (88.2)\u003c/p\u003e\n \u003cp\u003e119 (99.2)\u003c/p\u003e\n \u003cp\u003e24 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e46 (12.6)\u003c/p\u003e\n \u003cp\u003e12 (11.8)\u003c/p\u003e\n \u003cp\u003e1 (0.8)\u003c/p\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003cp\u003e0.818 (0.407\u0026ndash;1.643)\u003c/p\u003e\n \u003cp\u003e0.048 (0.006\u0026ndash;0.359)\u003c/p\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.031\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003e* Multiple logistic regression analysis. In calculating the odds ratio and 95% confidence interval, the effect of the confounding variables \u0026quot;history of pregnancy outcomes\u0026quot;, \u0026quot;underlying disease\u0026quot;, and \u0026quot;number of miscarriage history\u0026quot; has been adjusted. ** Including: Elective abortion, spontaneous abortion, and these categories were aggregated with each other in order to use logistic regression.\u003c/p\u003e\n\u003cp\u003eRegarding neonatal outcomes, no statistically significant relationship was observed between the type of vaccination, the number of vaccine doses, as well as the time of vaccination and perinatal mortality, low birth weight, and admission to the NICU (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05) (The tables are in the additional file).\u003c/p\u003e\n\u003cp\u003eBased on Table \u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e, the relationship between the type of vaccination and the outcome of neonatal jaundice in the investigated women is statistically significant (P\u0026thinsp;=\u0026thinsp;0.048); the women who received the Sinopharm vaccine compared to the women who did not receive the vaccine, had a significantly higher chance of neonatal jaundice (since the confidence interval established for the Sinopharm odds ratio does not cover the number 1). Also, the relationship between the number of vaccine doses in pregnancy and the outcome of neonatal jaundice in the examined women is statistically significant (P\u0026thinsp;=\u0026thinsp;0.021); the women who received two doses of the vaccine in pregnancy and compared to unvaccinated women, had a significantly higher chance of neonatal jaundice. In addition, the relationship between the time of vaccination in pregnancy and the outcome of neonatal jaundice in the examined women is statistically significant (P\u0026thinsp;=\u0026thinsp;0.003); the women who received at least one dose in the second trimester of pregnancy or at least one dose in the third trimester of pregnancy had a significantly higher chance of neonatal jaundice than women who did not receive the vaccine.\u003c/p\u003e\n\u003cp\u003eIn other words, receiving Sinopharm vaccine during pregnancy, receiving two doses of vaccine during pregnancy, receiving at least one dose in the second trimester of pregnancy, and receiving at least one dose in the third trimester of pregnancy would significantly increase the chance of neonatal jaundice outcome (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05).\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n \u003cdiv align=\"char\" class=\"colspec\"\u003e\u003cbr\u003e\u003c/div\u003e\u0026nbsp;\u003ctable id=\"Tab3\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eThe relationship between the type of vaccination, the number of vaccine doses, as well as the time of vaccination and neonatal jaundice in pregnant women referring to comprehensive health service centers (n-610)\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003ccolgroup cols=\"6\"\u003e\u003c/colgroup\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eNeonatal jaundice\u003c/p\u003e\n \u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Variable\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eNot occurred\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eoccurred\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eOdds ratio* (confidence interval 95%)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eP value\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003evaccination type\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eUnvaccinated (n-330)\u003c/p\u003e\n \u003cp\u003eSinopharm (n-225)\u003c/p\u003e\n \u003cp\u003eOther vaccines (n-21)\u003c/p\u003e\n \u003cp\u003ePre-pregnancy vaccine (n-34)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e172 (52.1)\u003c/p\u003e\n \u003cp\u003e92 (40.9)\u003c/p\u003e\n \u003cp\u003e9 (42.9)\u003c/p\u003e\n \u003cp\u003e17 (50.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e158 (47.9)\u003c/p\u003e\n \u003cp\u003e133 (59.1)\u003c/p\u003e\n \u003cp\u003e12 (57.1)\u003c/p\u003e\n \u003cp\u003e17 (50.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003cp\u003e1.680 (1.165\u0026ndash;2.422)\u003c/p\u003e\n \u003cp\u003e1.482 (0.583\u0026ndash;3.767)\u003c/p\u003e\n \u003cp\u003e1.322 (0.632\u0026ndash;2.766)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.048\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003enumber of vaccine doses during pregnancy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eUnvaccinated (n-364)\u003c/p\u003e\n \u003cp\u003eOne dose (n-91)\u003c/p\u003e\n \u003cp\u003eTwo dose (n-139)\u003c/p\u003e\n \u003cp\u003eThree dose (n-16)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e189 (51.9)\u003c/p\u003e\n \u003cp\u003e44 (48.4)\u003c/p\u003e\n \u003cp\u003e50 (36.0)\u003c/p\u003e\n \u003cp\u003e7 (43.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e175 (48.1)\u003c/p\u003e\n \u003cp\u003e47 (51.6)\u003c/p\u003e\n \u003cp\u003e89 (64.0)\u003c/p\u003e\n \u003cp\u003e9 (56.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003cp\u003e1.234 (0.764\u0026ndash;1.995)\u003c/p\u003e\n \u003cp\u003e1.958 (1.274\u0026ndash;3.008)\u003c/p\u003e\n \u003cp\u003e1.685 (0.578\u0026ndash;4.916)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.021\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003etiming of vaccination during pregnancy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eUnvaccinated (n-364)\u003c/p\u003e\n \u003cp\u003eAt least one dose in the first trimester (n-102)\u003c/p\u003e\n \u003cp\u003eAt least one dose in the second trimester (n-120)\u003c/p\u003e\n \u003cp\u003eAt least one dose in the third trimester (n-24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e189 (51.9)\u003c/p\u003e\n \u003cp\u003e51 (50.0)\u003c/p\u003e\n \u003cp\u003e43 (35.8)\u003c/p\u003e\n \u003cp\u003e7 (29.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e175 (48.1)\u003c/p\u003e\n \u003cp\u003e51 (50.0)\u003c/p\u003e\n \u003cp\u003e77 (64.2)\u003c/p\u003e\n \u003cp\u003e17 (70.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003cp\u003e1.083 (0.681\u0026ndash;1.724)\u003c/p\u003e\n \u003cp\u003e1.993 (1.266\u0026ndash;3.136)\u003c/p\u003e\n \u003cp\u003e3.562 (1.373\u0026ndash;9.240)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.003\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003e* Multiple logistic regression analysis. In calculating the odds ratio and 95% confidence interval, the effect of the confounding variables \u0026quot;history of pregnancy outcomes\u0026quot;, \u0026quot;history of neonatal outcomes\u0026quot;, and \u0026quot;underlying disease\u0026quot; has been adjusted.\u003c/p\u003e\n\u003cp\u003eNote that in pregnant women referring to comprehensive health service centers in Rafsanjan city in 2021 (n\u0026thinsp;=\u0026thinsp;610), there was no \u0026quot;maternal death\u0026quot; and only one case of \u0026quot;sepsis\u0026quot; occurred; therefore, it was not possible to examine the relationship between the type of vaccination, the number of vaccine doses, as well as the time of vaccination and the outcomes of maternal mortality and sepsis.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eIn this study, which was conducted with the aim of comparing maternal and newborn outcomes in vaccinated and unvaccinated pregnant women against COVID-19, based on the results obtained, pregnant women who received COVID-19 vaccine had reduced risk of miscarriage compared to unvaccinated women. However, in other related studies, no such relationship has been reported regarding vaccination against COVID-19 in pregnant women, and the results have only indicated no increase in miscarriage in vaccinated pregnant women compared to non-vaccinated women (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e, \u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e, \u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e). It seems that the findings are limited to examine this discrepancy, and there is probably a need to conduct further studies on the Sinopharm vaccine with a larger sample size, such as capturing the majority of pregnant people across the country.\u003c/p\u003e \u003cp\u003eIn our study, mild neonatal jaundice had increased in pregnant women vaccinated against COVID-19, while the study of Rottenstreich et al. (2021) indicated a reduction in hyperbilirubinemia in infants of mothers who received COVID-19 vaccine (\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e). It seems that the type of vaccine used in the mentioned study (Pfizer with mRNA technology), the larger sample size, and the difference in race and geographic region are probably the reasons behind the discrepancy in the results of this outcome. Nevertheless, in the study by Minghui Li et al. (2022), neonatal jaundice was increased in pregnant women who were vaccinated against COVID-19 compared to unvaccinated pregnant women (\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e). This result is similar to the finding of our study, which is probably due to the investigation of inactivated vaccines similar to our study.\u003c/p\u003e \u003cp\u003eAccording to the results of our study, blood pressure disorders in pregnancy and gestational diabetes in pregnant women vaccinated against COVID-19 were not different compared to women who were not vaccinated against COVID-19. This is similar to a systematic review study by Rahmati et al. (2023) and the study by S\u0026uuml;t et al in spite of examining COVID-19 vaccines made via mRNA technology. Probably, vaccination generally and with any platform can help prevent the increase of these complications (\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e, \u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eBased on the findings of our study, premature rupture of the amniotic sac and premature delivery were not associated with an increase among pregnant women vaccinated against COVID-19 compared to non-vaccinated pregnant women. In the results of the study by S\u0026uuml;t et al. (2024) and the study by Minghui Li et al. (2022), vaccination against COVID-19 has again been associated with no increase in premature rupture of the amniotic sac and premature delivery, compared to unvaccinated women (\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e, \u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e). In the first study, mRNA platform vaccines were used while in the second study, inactivated vaccines were employed. Nevertheless, in the results of the systematic review study by Shafiee et al. (2023) as well as in the review study by Rahmati et al. (2023) they had noted diminished premature delivery among mothers vaccinated against COVID-19, as compared to unvaccinated pregnant mothers (\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e, \u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e). This discrepancy is probably due to the large sample size of these studies (at least 10 times larger than our sample size) and the type of vaccine investigated. However, according to the results of Hatami et al.'s (2024) study, premature delivery increased in pregnant mothers who were vaccinated in the first trimester compared to non-vaccinated mothers (\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eAccording to the results obtained in our study, there was no increase in the rate of hospitalization of mothers and infection with COVID-19 in people who were vaccinated by COVID-19 vaccine compared to mothers who were not vaccinated. This result is contrary to the study of Favre et al. (2023) regarding the effect of not being vaccinated on the increase in the hospitalization rate of mothers (\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e). However, it is in line with the results of a review study by Prasad et al. (2022) in which vaccination in pregnant women was associated with no increase in maternal hospitalization (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e). In a contradictory study, the increase in hospitalization of mothers had happened before the outbreak of the delta variant, while our study and the study in line with ours considered the time range of the outbreak of the delta variant.\u003c/p\u003e \u003cp\u003eThe results of our study also revealed that vaccination against COVID-19 in pregnant women was not associated with a difference in terms of caesarean section and maternal death. Similarly, the systematic review study by Rahmati et al. (2023) also reported no increase in cesarean section in vaccinated pregnant women compared to non-vaccinated mothers (\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e). The result of the study by Prasad et al. (2022) indicated no increase in maternal mortality in pregnant women who were vaccinated against COVID-19 compared to unvaccinated pregnant women (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e). This lack of increase in the mentioned outcomes can be due to the importance of vaccination against COVID-19, regardless of the type of vaccine.\u003c/p\u003e \u003cp\u003eIn the results obtained from our study, vaccination against COVID-19 in pregnant women did not change the rate of perinatal mortality and stillbirth, while in the study of Stock et al. (2022) all cases of perinatal mortality occurred only in unvaccinated pregnant women infected with COVID-19 [12]. In the study of Schwarts et al. (2023), the risk of stillbirth was mentioned only in pregnant women who were not vaccinated against COVID-19 (\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e). Also, the results of two review studies by Prasad et al. (2022) and the study by Rahmati et al. (2023) indicated a reduction in the risk of stillbirth in pregnant women vaccinated against COVID-19 compared to pregnant women who were not vaccinated against COVID-19 (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e, \u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e). These results were contrary to our findings. In these studies, in most of the cases, the utilized vaccine was the mRNA platform, while the result observed in our study was obtained from the investigation of the inactivated vaccine (36.9% of cases being Sinopharm).\u003c/p\u003e \u003cp\u003eIn the present study, neonatal outcomes such as low birth weight, NICU admission, and sepsis were not different either in pregnant women who were vaccinated against COVID-19 compared to unvaccinated pregnant mothers. These results were in line with other related studies which pointed to the lack of low birth weight and admission to the NICU (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e, \u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e, \u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e, \u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e). Regarding sepsis, no similar study was found that had investigated this outcome in these two groups of women.\u003c/p\u003e \u003cp\u003eOne of the limitations of our study was the lack of accurate recording of all maternal and neonatal outcomes in the SIB system, and as a result, the loss of a number of samples, as well as the lack of access to the information of mothers who did not respond to their phone calls.\u003c/p\u003e \u003cp\u003eThe strength of our study was the direct communication with the mothers themselves; we were able to receive and record all the necessary information from them.\u003c/p\u003e \u003cp\u003eIt is suggested that this study be investigated in a larger statistical population to explore long-term maternal and neonatal outcomes.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe results of this study indicated that the COVID-19 vaccination (inactivated vaccines) in pregnant women was not associated with any special complication that would increase an outcome. Only the chance of newborn jaundice increased, though the neonatal jaundice was of a mild type and these babies did not need to be hospitalized. It seems that in order to obtain more accurate results, there is a need to conduct studies with a larger sample size and compare different types of vaccines.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003col start=\"1\" type=\"1\"\u003e\n \u003cli\u003eSARS-COV-2: The virus that causes the disease known as coronavirus disease 2019\u003c/li\u003e\n \u003cli\u003eICU: Intensive Care Unit\u003c/li\u003e\n \u003cli\u003eECMO: Extra-corporal membrane oxygenation\u003c/li\u003e\n \u003cli\u003emRNA: Messenger RNA\u003c/li\u003e\n \u003cli\u003eLMP: Last menstrual period\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eConsent\u003c/strong\u003e \u003cstrong\u003eto participate and for publication:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInformed Consent Form\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInformed Consent for Participation in Research Study\u003c/p\u003e\n\u003cp\u003eRafsanjan University of Medical Sciences\u003c/p\u003e\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26.6223%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTitle of Research Project\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 73.3777%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eComparing the maternal and neonatal outcomes in vaccinated and unvaccinated pregnant women against COVID-19: a retrospective cohort study\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26.6223%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eName(s) of Researcher(s)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 73.3777%;\"\u003e\n \u003cp\u003eZahra Gholami, Maryam Mohseni, Pouran Allahbakhshi Nasab\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26.6223%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRelevant Faculty or Unit\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 73.3777%;\"\u003e\n \u003cp\u003eFaculty of Nursing and Midwifery, Midwifery Group\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26.6223%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIntroduction to the Research\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 73.3777%;\"\u003e\n \u003cp\u003eIn this descriptive comparative study, contact information for pregnant mothers will initially be extracted from the Integrated Health System of Iran (SIB). Subsequently, the researcher will complete a checklist through a phone call after obtaining the mother\u0026apos;s consent. The research sample includes women whose pregnancies began during the first six months of the COVID-19 vaccination rollout (from July 22, 2021, to December 21, 2021). Pregnant mothers will be divided into two groups based on whether or not they received the vaccine during pregnancy: vaccinated and unvaccinated. Maternal and neonatal outcomes in these two groups will be compared. The number of doses, type, and timing of vaccine administration will be queried in the questionnaire and will be taken into account during the analysis.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26.6223%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eBenefits\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 73.3777%;\"\u003e\n \u003cp\u003eThis research does not provide direct benefits to participants, but participation may enhance the awareness and knowledge of healthcare workers and the community in this area.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26.6223%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSide Effects\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 73.3777%;\"\u003e\n \u003cp\u003eThis study has no associated side effects.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26.6223%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCosts Related to Conducting the Research Project\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 73.3777%;\"\u003e\n \u003cp\u003eThe costs of this study will be borne by the researcher, and participants will not incur any expenses\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26.6223%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eConfidentiality:\u003cbr\u003e\u0026nbsp;Results from the\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 73.3777%;\"\u003e\n \u003cp\u003echecklist and methodology will be communicated to the participants and will be used strictly for research purposes. Information regarding the participants will remain confidential within the bounds of the law, society, and family.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26.6223%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eResponding to Questions:\u003cbr\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 73.3777%;\"\u003e\n \u003cp\u003eThe researcher will respond any questions related to the project through the following contact number: +98 916 870 2600\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26.6223%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRight to Refuse or Withdraw\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 73.3777%;\"\u003e\n \u003cp\u003eInformation will be gathered through phone calls with mothers, and responding to the checklist questions will be optional and voluntary\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26.6223%;\"\u003e\n \u003cp\u003e\u003cstrong\u003eConsent (in full awareness and stress-free conditions):\u003cbr\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 73.3777%;\"\u003e\n \u003cp\u003eBased on the information contained in this form and the explanations provided by the researcher or their colleagues, I hereby express my agreement to participate in this study.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data that support the findings of this study are available from Zahra Gholami but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of Zahra Gholami.\u003c/p\u003e\n\u003cp\u003eHowever, the data is organized in such a way that each individual is assigned a number, and then the checklist information for that individual is recorded in an SPSS file.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eZ GH: design of the work, have drafted the work, writing the text of the article and sampling\u003c/p\u003e\n\u003cp\u003eM M: design of the work, review and correction of the text of the article, advice on sampling, statistical analysis (corresponding author)\u003c/p\u003e\n\u003cp\u003eP AN: Reviewing and correcting the text of the article, Advice on designing the work, Completing the initial SPSS file for analysis\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical Trial:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical train number:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; information\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eZahra Gholami\u003csup\u003e1\u003c/sup\u003e, Maryam Mohseni\u003csup\u003e2*\u003c/sup\u003e, Pouran\u0026nbsp;Allahbakhshi Nasab\u003csup\u003e3\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e1. Master\u0026apos;s in Midwifery, Dept. of midwifery, School of Nursing and Midwifery, Rafsanjan University of Medical Sciences, Rafsanjan, Iran\u003c/p\u003e\n\u003cp\u003eE-mail: [email protected]\u003c/p\u003e\n\u003cp\u003e2. PhD in reproductive health, Associate Professor, Dept. of Midwifery, School of Nursing and Midwifery, Geriatric Care Research Center, Rafsanjan University of Medical Sciences, Rafsanjan, Iran\u003cbr\u003e\u003cstrong\u003e*(Corresponding author)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eE-mail: [email protected]\u003c/p\u003e\n\u003cp\u003e3. Master\u0026apos;s in Midwifery, Instructor, Dept. of Midwifery, School of Nursing and Midwifery, Geriatric Care Research Center, Rafsanjan University of Medical Sciences, Rafsanjan, Iran\u003c/p\u003e\n\u003cp\u003eE-mail: [email protected]\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e*. Corresponding author: Maryam Mohseni\u003c/strong\u003e\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eAlavian F, Alavian K, Pregnancy. COVID-19: physiology, some challenges, and solutions. Iran J Obstet Gynecol Infertility. 2021;24(1):99\u0026ndash;111.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAbedzadeh-Kalahroudi M, Karimian Z, Nasiri S, Khorshidifard MS. Anxiety and perceived stress of pregnant women towards Covid-19 disease and its related factors in Kashan (2020). Iran J Obstet Gynecol Infertility. 2021;24(5):8\u0026ndash;18.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMarshall JE, Raynor MD. Myles' Textbook for Midwives E-Book: Myles' Textbook for Midwives E-Book. Elsevier Health Sciences; 2014.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhao X, Jiang Y, Zhao Y, Xi H, Liu C, Qu F, et al. Analysis of the susceptibility to COVID-19 in pregnancy and recommendations on potential drug screening. Eur J Clin Microbiol Infect Dis. 2020;39:1209\u0026ndash;20.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFan C, Lei D, Fang C, Li C, Wang M, Liu Y, et al. Perinatal transmission of 2019 coronavirus disease\u0026ndash;associated severe acute respiratory syndrome coronavirus 2: should we worry? Clin Infect Dis. 2021;72(5):862\u0026ndash;4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJahanbakhsh SS, Taghavi Gilani M, Hashemian A, Rais Assadat B. Review of cardiopulmonary resuscitation in pregnant Women. Iran J Obstet Gynecol Infertility. 2007;10(2):87\u0026ndash;96.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRajabzadeh R, Hamid Hoseini S, Rezazadeh J, Baghban A, Nasiri M, Hosein Ayati M. Prevalence of anemia and its related factors in pregnant women referring to health centers of Mane and Samalghan city. Iran J Obstet Gynecol Infertility. 2015;18(171):1\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFazeli E, Tafazzoli M, Dadgar S, Seyed Ahmadinezhad F. The role of carbohydrates and dietary energy intake in functional ovarian cysts. Iran J Obstet Gynecol Infertility. 2015;18(152):9\u0026ndash;15.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGoodnight WH, Soper DE. Pneumonia in pregnancy. Crit Care Med. 2005;33(10):S390\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eStock SJ, Carruthers J, Calvert C, Denny C, Donaghy J, Goulding A, et al. SARS-CoV-2 infection and COVID-19 vaccination rates in pregnant women in Scotland. Nat Med. 2022;28(3):504\u0026ndash;12.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAllotey J, Fernandez S, Bonet M, Stallings E, Yap M, Kew T et al. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. 2020;370.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZambrano LD. Update: characteristics of symptomatic women of reproductive age with laboratory-confirmed SARS-CoV-2 infection by pregnancy status\u0026mdash;United States, January 22\u0026ndash;October 3, 2020. MMWR Morbidity and mortality weekly report. 2020;69.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eUptodate. COVID-19: Overview of pregnancy issues https://www3.utdos.ir/contents/search?search=covid19%20in%20pregnancy\u0026amp;sp=0\u0026amp;searchType=PLAIN_TEXT\u0026amp;source=USER_INPUT \u0026amp;searchControl=TOP_PULLDOWN\u0026amp;searchOffset=1\u0026amp;autoComplete=false\u0026amp;language=en \u0026amp;max=10\u0026amp;index=\u0026amp;autoCompleteTerm=20222022[\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVillar J, Ariff S, Gunier RB, Thiruvengadam R, Rauch S, Kholin A, et al. Maternal and neonatal morbidity and mortality among pregnant women with and without COVID-19 infection: the INTERCOVID multinational cohort study. JAMA Pediatr. 2021;175(8):817\u0026ndash;26.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePapageorghiou AT, Deruelle P, Gunier RB, Rauch S, Garc\u0026iacute;a-May PK, Mhatre M, et al. Preeclampsia and COVID-19: results from the INTERCOVID prospective longitudinal study. Am J Obstet Gynecol. 2021;225(3):289. e1-. e17.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWei SQ, Bilodeau-Bertrand M, Liu S, Auger N. The impact of COVID-19 on pregnancy outcomes: a systematic review and meta-analysis. CMAJ. 2021;193(16):E540\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKnight M, Bunch K, Vousden N, Morris E, Simpson N, Gale C et al. Characteristics and outcomes of pregnant women admitted to hospital with confirmed SARS-CoV-2 infection in UK: national population based cohort study. BMJ. 2020;369.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVousden N, Bunch K, Morris E, Simpson N, Gale C, O\u0026rsquo;Brien P, et al. The incidence, characteristics and outcomes of pregnant women hospitalized with symptomatic and asymptomatic SARS-CoV-2 infection in the UK from March to September 2020: a national cohort study using the UK Obstetric Surveillance System (UKOSS). PLoS ONE. 2021;16(5):e0251123.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMullins E, Hudak ML, Banerjee J, Getzlaff T, Townson J, Barnette K, et al. Pregnancy and neonatal outcomes of COVID-19: coreporting of common outcomes from PAN‐COVID and AAP‐SONPM registries. Ultrasound Obstet Gynecol. 2021;57(4):573\u0026ndash;81.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDi Mascio D, Khalil A, Saccone G, Rizzo G, Buca D, Liberati M, et al. Outcome of coronavirus spectrum infections (SARS, MERS, COVID-19) during pregnancy: a systematic review and meta-analysis. Am J Obstet Gynecol MFM. 2020;2(2):100107.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKudlay D, Svistunov A. COVID-19 vaccines: an overview of different platforms. Bioengineering. 2022;9(2):72.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShook LL, Fallah PN, Silberman JN, Edlow AG. COVID-19 vaccination in pregnancy and lactation: current research and gaps in understanding. Front Cell Infect Microbiol. 2021;11:735394.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWoodworth KR. Birth and infant outcomes following laboratory-confirmed SARS-CoV-2 infection in pregnancy\u0026mdash;SET-NET, 16 jurisdictions, March 29\u0026ndash;October 14, 2020. MMWR Morbidity and Mortality Weekly Report. 2020;69.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSabouni M. govazi s. COVID-19 vaccination in pregnant women. Behvarz Quarterly. 2022;33(112):44\u0026thinsp;\u0026ndash;\u0026thinsp;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNdwandwe D, Wiysonge CS. COVID-19 vaccines. Curr Opin Immunol. 2021;71:111\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMouro V, Fischer A. Dealing with a mucosal viral pandemic: lessons from COVID-19 vaccines. Mucosal Immunol. 2022;15(4):584\u0026ndash;94.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePeretz-Machluf R, Hirsh-Yechezkel G, Zaslavsky-Paltiel I, Farhi A, Avisar N, Lerner-Geva L, et al. Obstetric and neonatal outcomes following COVID-19 vaccination in pregnancy. J Clin Med. 2022;11(9):2540.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePrasad S, Kalafat E, Blakeway H, Townsend R, O\u0026rsquo;Brien P, Morris E, et al. Systematic review and meta-analysis of the effectiveness and perinatal outcomes of COVID-19 vaccination in pregnancy. Nat Commun. 2022;13(1):1\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoHaMTo I. covid-19 vaccination in pregnancy https://shc.sbmu.ac.ir/uploads/205/%D8%A8%D9%87%D8%AF%D8%A7%D8%B4%D8%AA%20%D8%AE%D8%A7% D9%86%D9%88%D8%A7%D8%AF%D9%87/%D9%85%D8%A7%D8% AF%D8%B1%D8%A7%D9%86/%D8%AF%D8% B3%D8%AA%D9%88%D8%B1%D8%A7%D9%84%D8%B9%D9%85%D9%84%20%D9%85%D8%A7%D8%AF%D8% B1%D8%A7%D9%86%20%D8%A8%D8%A7%D8%B1%D8%AF%D8%A7%D8%B1%20%D8%AF%D8%B1%20% DA%A9%D8%B1%D9%88%D9%86%D8%A7/%D8%A2% D8%AE%D8%B1%DB%8C%D9%86%20%D8%AF%D8%B3%D8%AA%D9%88%D8%B1%D8%A7%D9%84%D8%B9% D9%85%D9%84%20%D9%88%D8%A7%DA%A9% D8%B3%D9%86%20%DA%A9%D9%88%D9%88%DB%8C%D8%AF_1.pdf20212021 [.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoaya M, Shahali S, Farhoudi B. Maternal and neonatal outcomes of pregnant women with COVID-19 in Amir-al-momenin hospital during March to May 2020. Iran J Obstet Gynecol Infertility. 2020;23(9):35\u0026ndash;42.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFayazi M, Rahmani R, Bilandi RR. Clinical manifestations, maternal, fetal and neonatal outcomes in pregnant women with COVID-19: a systematic review. 2021.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKarimi L, Makvandi S, Vahedian-Azimi A, Sathyapalan T, Sahebkar A. Effect of COVID-19 on mortality of pregnant and postpartum women: a systematic review and meta‐analysis. J pregnancy. 2021;2021(1):8870129.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRahmati M, Yon DK, Lee SW, Butler L, Koyanagi A, Jacob L, et al. Effects of COVID-19 vaccination during pregnancy on SARS‐CoV‐2 infection and maternal and neonatal outcomes: A systematic review and meta‐analysis. Rev Med Virol. 2023;33(3):e2434.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eS\u0026uuml;t H, Yıldız GA, Şeker E, \u0026Uuml;mit C, Ko\u0026ccedil;ar M, Ko\u0026ccedil; A. Maternal and perinatal outcomes of COVID-19 vaccination during pregnancy. J Turkish German Gynecol Association. 2023;24(2):120.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRottenstreich M, Sela H, Rotem R, Kadish E, Wiener-Well Y, Grisaru‐Granovsky S. Covid‐19 vaccination during the third trimester of pregnancy: rate of vaccination and maternal and neonatal outcomes, a multicentre retrospective cohort study. BJOG: Int J Obstet Gynecol. 2022;129(2):248\u0026ndash;55.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLi M, Hao J, Jiang T, Deng W, Lu H, Wang S, et al. Maternal and neonatal safety of COVID-19 vaccination during the peri‐pregnancy period: a prospective study. J Med Virol. 2023;95(1):e28378.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShafiee A, Kohandel Gargari O, Teymouri Athar MM, Fathi H, Ghaemi M, Mozhgani S-H. COVID-19 vaccination during pregnancy: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2023;23(1):45.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHatami D, Habibelahi A, Changizi N, Heidarzadeh M, Nojomi M, Rast M, et al. Perinatal outcomes and sinopharm BBIBP-CorV vaccination during pregnancy. BMC Pregnancy Childbirth. 2024;24(1):190.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFavre G, Maisonneuve E, Pomar L, Daire C, Poncelet C, Quibel T et al. Maternal and perinatal outcomes following pre-Delta, Delta, and Omicron SARS-CoV-2 variants infection among unvaccinated pregnant women in France and Switzerland: a prospective cohort study using the COVI-PREG registry. Lancet Reg Health\u0026ndash;Europe. 2023;26.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSchwartz DA, Mulkey SB, Roberts DJ. SARS-CoV-2 placentitis, stillbirth, and maternal COVID-19 vaccination: clinical\u0026ndash;pathologic correlations. Am J Obstet Gynecol. 2023;228(3):261\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBadell ML, Dude CM, Rasmussen SA, Jamieson DJ. Covid-19 vaccination in pregnancy. BMJ. 2022;378.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Footnotes","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003e The virus that causes the disease known as coronavirus disease 2019\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003e Intensive Care Unit\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003e Extra-corporal membrane oxygenation\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003e Messenger RNA\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003e Last menstrual period\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-pregnancy-and-childbirth","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"prch","sideBox":"Learn more about [BMC Pregnancy and Childbirth](http://bmcpregnancychildbirth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/prch/default.aspx","title":"BMC Pregnancy and Childbirth","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"COVID-19 vaccination, neonatal and maternal outcomes, miscarriage, neonatal jaundice, pregnant women","lastPublishedDoi":"10.21203/rs.3.rs-5349935/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5349935/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eAfter the emergence of the COVID-19 disease due to the limited number of studies on vaccination of pregnant mothers and the fact that the vaccine used in Iran has been different from the ones employed in other countries, this study aimed to compare maternal and neonatal outcomes in vaccinated and unvaccinated women against COVID-19.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis retrospective cohort study was done in the comprehensive healthcare centers of Rafsanjan city. First, the contact information of expectant mothers who were pregnant from 22th June 2021 to 22th December 2021 was extracted using Iran's integrated health care system (SIB); then during a phone call, the required information in was registered in a checklist. Out of 969 pregnant women, after checking the inclusion and exclusion criteria, only 610 subjects were included in the study. Out of this number, 330 had not been vaccinated, while the rest had received inactivated COVID-19 vaccine before or during pregnancy. The maternal and neonatal outcomes were compared between vaccinated and unvaccinated women. The data were analyzed using SPSS 26 software and one-way analysis of variance (One-way ANOVA), Tukey multiple comparison, Fisher's exact test or Chi-square test, and multiple logistic regression.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe results of this study revealed that vaccination against COVID-19 in pregnant women significantly increased the probability of jaundice in the neonate (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05), but the miscarriage rate in these women was significantly lower (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05). No adverse outcomes were observed such as high blood pressure, gestational diabetes, maternal hospitalization, maternal infection with COVID-19, premature delivery, premature rupture of the amniotic sac, perinatal death, admission to the neonatal intensive care unit, and low birth weight.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eCOVID-19 vaccination among pregnant women is recommended to prevent from adverse neonatal and maternal outcomes.\u003c/p\u003e","manuscriptTitle":"Comparing the maternal and neonatal outcomes in vaccinated and unvaccinated pregnant women against COVID-19: a retrospective cohort study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-11-27 17:34:10","doi":"10.21203/rs.3.rs-5349935/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-11-04T11:52:54+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-11-04T09:37:17+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-11-01T06:26:27+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Pregnancy and Childbirth","date":"2024-10-28T23:11:17+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-pregnancy-and-childbirth","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"prch","sideBox":"Learn more about [BMC Pregnancy and Childbirth](http://bmcpregnancychildbirth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/prch/default.aspx","title":"BMC Pregnancy and Childbirth","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"f814250e-8745-4549-b811-10a489878236","owner":[],"postedDate":"November 27th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-03-31T16:02:32+00:00","versionOfRecord":{"articleIdentity":"rs-5349935","link":"https://doi.org/10.1186/s12884-025-07462-x","journal":{"identity":"bmc-pregnancy-and-childbirth","isVorOnly":false,"title":"BMC Pregnancy and Childbirth"},"publishedOn":"2025-03-28 15:57:44","publishedOnDateReadable":"March 28th, 2025"},"versionCreatedAt":"2024-11-27 17:34:10","video":"","vorDoi":"10.1186/s12884-025-07462-x","vorDoiUrl":"https://doi.org/10.1186/s12884-025-07462-x","workflowStages":[]},"version":"v1","identity":"rs-5349935","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5349935","identity":"rs-5349935","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}