Timing of induction of labor with catheter –  a prospective randomized study with special reference to setting, parity and obesity

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We aimed to evaluate timing between IOL with catheter and delivery. Methods: Altogether, 108 women with planned IOL were included in prospective randomized study. Five different time intervals were evaluated: 1) insertion to expulsion of catheter 2) expulsion of catheter to delivery 3) amniotomy to delivery 4) IOL to delivery and 5) the total admission time by setting (outpatient [OP]/inpatients [IP]), parity (primiparous/multiparous) and body mass index (obese/non-obese). Results: For IOL setting, the time in the hospital was 17.5 hours longer in the IP group, with no other differences. All time intervals were longer for primiparous than for multiparous women. The same was true for obese women, compared to non-obese women, except in the insertion–expulsion time. When IOL was performed during office hours, 57.4% of women delivered between 6pm and 6am, and 42.6% between 6am and 6pm ( P =0.124). Furthermore, 66.7% of multiparous and 50.0% of obese women delivered between 6pm and 6am, with no difference between settings. Conclusions: The setting of catheter IOL did not compromise delivery times. Instead, parity and marginally obesity showed importance. catheter induction of labor obesity outpatient inpatient parity timing Figures Figure 1 Figure 2 Introduction The frequency of induction of labor (IOL) is rising word wide. In the United States, more than 30% of deliveries were induced in 2020[ 1 ]. The IOL rate in Finland was 35% in 2022, which was higher than ever before[ 2 ]. Increasing maternal age, obesity and co-morbidities during pregnancy have added pregnancy complications and thus, increased the need for IOL[ 3 , 4 ]. Furthermore, IOL is occasionally carried out because for logistic reasons (e.g. long distance to the hospital), social reasons (e.g. family problems) or the request of the pregnant woman[ 5 ]. The aim of successful IOL is to reduce the pregnancy complications, shorten the induction to delivery interval, achieve vaginal delivery, and healthy new-borns. IOL is typically planned electively during office hours. However, this procedure may, at least partly, lead to duty time deliveries, which is typically a time when personnel is scanter. In addition, a decrease in alertness and performance is evident during duty time and night shift work[ 6 ], which may lead to increased errors[ 7 , 8 ] and thus presumably to perinatal adverse outcomes[ 9 ]. Optimising the outcome of planned delivery often involves labor during office hours. However, few previous studies have assessed the time intervals during IOL or evaluated the optimal time of day for IOL[ 3 ]. In a meta-analysis with 8 trials, no difference between Foley catheter and prostaglandins was found in the median time to delivery[ 10 ]. However, Foley catheter is much cheaper than vaginal used prostaglandins[ 11 ]. As for setting of IOL, the outpatient (OP) group with catheter spent a shorter time in hospital than the inpatient (IP) group, with a median difference of 7.2 hours[ 10 ]. Furthermore, in a randomised study by Policiano et al. with OP and IP settings, the average total IOL-to-delivery time was shorter in the OP group than in the IP group[ 12 ]. Also, several maternal characteristics may interfere with the duration of IOL, most probably parity and body mass index (BMI). In general, multiparous women have shorter IOL-delivery times than primiparous women[ 13 ], and in obese women risk for failing IOL is increased[ 14 ]. The principal aim of our prospective randomized study was to evaluate the time intervals of catheter IOL in OP and IP settings. As the secondary aim, we assessed the effects of parity and obesity on the time intervals. We were especially interested in whether women with office time inductions more often have duty time deliveries. Material and methods This study was part of a prospective randomised controlled IOL study performed between July 2016 and December 2019 at Turku University Hospital, Finland. Pregnant women who entered the department for a planned induction of labor and volunteered for the study were enrolled. The inclusion criteria were singleton-term pregnancy in gestational week (gwk) 37–41 + 5, cephalic presentation, intact membranes, a Bishop score < 6, normal cardiotocography (CTG), sufficient knowledge of Finnish to fill in the study questionnaire and short distance to the hospital (at most half an hour drive). Exclusion criteria included any severe pregnancy complications (e.g. hypertensive pregnancy, medically treated gestational diabetes, intrauterine growth restriction, signs of fetal distress). Cervix status was examined by a gynecological examination and transvaginal ultrasound. A double-balloon catheter (the Cook®, Cervical Ripening Balloon Catheter J-CRBS-184000) was used for IOL. As a routine, both balloons were filled in with 80ml saline, unless causing constant pain: in that case, part of the saline, mostly from the lower balloon, was emptied. In six cases, where IOL was performed by physicians not involved in the study by change, only single balloon catheter with 60-80ml filling were used (two in the OP group and four in the IP group). However, single balloon catheter has previously shown to be at least comparable to double balloon catheter in terms of vaginal birth rate and maternal and perinatal safety outcomes[ 15 ]. Thereafter, the women were randomised to either the OP or IP group. Randomization was conducted by a professional statistician using a computer-generated random number list, and the codes were placed in sequentially numbered, sealed opaque envelopes. The sample size was initially calculated to detect a significant difference in satisfaction scores on the VAS scale between outpatient and inpatient groups, as satisfaction was the primary outcome for our original study[ 16 ]. For the purpose of this analysis, sample size adequacy was re-evaluated with duration as the outcome variable. Using the observed standard deviation in duration from our study and aiming for 80% power, a sample size of 37 subjects per group would have been sufficient to detect a two-hour difference between groups. Actual sample sizes of n = 53 and n = 55 per group provide approximately 93% power for this analysis. Altogether 117 women with planned IOL were enrolled. Nine women withdrew from the study after randomisation and thus: four wanted another than the randomised, 108 women were included in the study: 53 women in the OP group and 55 in the IP group (Fig. 1 ). Catheter insertion was performed in 73.1% (n = 79/108) of the women between 8 am and 12 am and in 26.9% (n = 29/108) between 12 am and 4 pm. Basic characteristics, including parity (primiparous/multiparous), gwk, body mass index (BMI, kg/m 2 ), Bishop score and cervix length (mm) by ultrasound were collected from patients’ files (Table 1). Two additional groups of interest were formed: parity (primiparous and multiparous) and body mass index (BMI, ≤ 30 kg/m 2 = non-obese and > 30 kg/m 2 = obese). The information about the delivery and new-born outcomes are presented in Supplementary Tables 1 and 2. After randomisation and CTG control, the women in the OP group were discharged with written instructions regarding OP induction, and the women in the IP group stayed at the hospital. The women in both groups were instructed by midwifes how to pull catheter outwards once an hour. The time between discharge and re-admittance of all women in the OP group was assessed. Five time intervals of labor were evaluated: 1) insertion to expulsion of catheter (insertion–expulsion time), 2) expulsion of catheter to delivery (expulsion–delivery time), 3) amniotomy to delivery (amniotomy–delivery time), 4) IOL to delivery (IOL–delivery time) and 5) the total time in the hospital (total admission time). All these times were analysed in three groups: between the OP and IP groups, between the primiparous and multiparous groups, and between the obese and non-obese groups. In addition, the clock times of the insertion of the catheter and delivery were evaluated in all group comparisons. Statistical analyses First, the distributions of all variables were visually evaluated to select appropriate descriptive statistics and statistical tests. Normally distributed variables are reported with means and standard deviations (SDs), and analysis of variance (ANOVA) was used to compare the groups. Skewed distributions are reported with medians and lower (Q1) and upper quartiles (Q3). Wilcoxon rank sum tests were performed to compare the groups. Categorical variables are summarised with frequencies and percentages. Associations between categorical variables were tested with a Chi-squared test. The time intervals were analysed as continuous, except the IOL–delivery time was considered both continuous and categorical (48 hours). All time intervals were calculated as median survival times with 95% confidence intervals (CIs) using the Kaplan–Meier approach, and the groups were compared using the log-rank test. In contrast, quantile regression was used to calculate the differences in the medians with 95% CIs and P -values. The associations between categorical IOL delivery times and setting, parity and BMI groups were analysed using Chi-squared tests. The significance level was set at 0.05. All tests were performed as two-sided. The data were collected using IBM SPSS Statistics version 27, and all analyses were performed using SAS (Version 9.4) for Windows. Graphs were constructed in R version 4.2.1 using the ggplot2 package. Results All women The time intervals for all women are shown in Table 2 and Fig. 2 . The median IOL–delivery time of all women was 30.2 hours (95%CI 27.0–35.4) and the median expulsion–delivery time was 15.2 hours (95%CI 12.3–18.5 hours). The median IOL–delivery time was 28.2 hours (95%CI 22.1–32.0; n = 87) in women who had a vaginal delivery and 49.1 hours (95%CI 32.0–67.7; n = 21) in women who had a cesarean section. The median total time in the hospital was 4.1 days (95%CI 3.5–4.6). Of all women studied, 42.6% (n = 46) delivered between 6 am and 6 pm, and 57.4% (n = 62) delivered between 6 pm and 6 am (Table 3). Comparison between the OP and IP groups In the OP group, the median time between discharge and re-admittance with the catheter was 17.5 hours (95%CI 10.6–19.7 hours). Of the women in the OP group, 20 (37.7%) returned to the hospital before the scheduled time. Eighteen women returned because of the expulsion of the catheter; one woman had contractions that were too painful, and one had broken membranes. Between the OP and IP groups, there were no differences in insertion–expulsion times, expulsion–delivery times, amniotomy–delivery times or IOL–delivery times (Table 2, Fig. 2 ). The total time in the hospital was 28.3 hours (95%CI 6.7–49.9) longer in the IP group ( P = 0.011). In the OP and IP groups, the catheter was inserted between 8 am and 12 am in 69.8% (n = 37) and 76.4% (n = 42), respectively ( P = 0.371), and between 12 am and 4 pm in 30.2% (n = 16) and 23.6% (n = 13), respectively ( P = 1.00). Of the women, 54.7% (n = 29) in the OP group and 60.0% (n = 33) in the IP group delivered between 6 pm and 6 am, while 45.3% (n = 24) in the OP group and 40.0% (n = 22) in the IP group delivered between 6 am and 6 pm (Table 3). The frequency distribution did not differ between the groups ( P = 0.579). There were no differences in the delivery or new-born outcomes between the groups (Supplementary Tables 1 and 2). Comparisons between primiparous and multiparous women In primiparous women, the median insertion–expulsion time was 10.2 hours longer than in multiparous women (95%CI 5.9–14.4; P < 0.0001). The expulsion–amniotomy time did not differ ( P = 0.42). Compared to multiparous women, the median amniotomy–delivery time was 8.2 hours longer (95%CI 4.0–12.3; P < 0.0001) and the median IOL–delivery time was 17.0 hours longer (95%CI 9.4–24.6; P < 0.0001) in primiparous women. The median expulsion–delivery time was 19.8 hours (95%CI 14.8–25.1) in primiparous women and 10.0 hours (95%CI 7.7–12.4) in multiparous women ( P = 0.0005) (Table 2, Fig. 2 ). The group and individual IOL delivery times are illustrated in Fig. 2 . The IOL delivery time was under 24 hours in 18.2% and 59.5%, between 24 and 48 hours in 48.5% and 28.6%, and over 48 hours in 33.3% and 11.9% of primiparous and multiparous women, respectively ( P < 0.0001, Table 4). The majority of the catheters (73.1%, n = 79/108) were inserted between 8 am and 12 pm; accordingly, 50.9% (n = 26) of primiparous and 64.3% (n = 18) of multiparous women delivered between 6 pm and 6 am. When the catheter was inserted between 12 pm and 4 pm, 73.3% (n = 11) of primiparous and 71.4% (n = 10) of multiparous delivered between 6 pm and 6 am (Table 3). Comparison between obese and non-obese groups Compared to the non-obese group, the expulsion–delivery time, amniotomy–delivery time and IOL–delivery time were 13.9 hours (95%CI 3.1–30.9; P < 0.0017), 9.8 hours (95%CI 0.8–32.5; P = 0.004) and 15.9 hours longer (95%CI 0.8–32.5; P = 0.061), respectively, for obese women. The total hospital time was more than one day longer (95%CI 0.05–2.2; P = 0.041) for obese women (Table 2). In primiparous women, the median IOL–delivery time was 34.4 hours among non-obese women (n = 51, 95%CI 28.8–39.1) and 49.1 hours among obese women (95%CI 32.0–61.2, n = 15). In multiparous, the median IOL–delivery time was 21.3 hours in non-obese women (95%CI 15.0–26.6, n = 37) and 20.0 hours in obese women (95%CI 13.4–NA, n = 5). Discussion According to our study, regarding the setting, the only difference was the shorter total time in hospital in the OP group, which was expected. Nevertheless, the clock time of delivery was not dependent on the setting. Instead, the time intervals differed on one hand in comparisons between primiparous and multiparous women and on the other hand in comparisons between obese and non-obese women. Both multiparous and non-obese women had shorter time intervals. As the women in our study were enrolled among those with planned IOL, for logistical reasons, the catheters were mainly inserted during office hours, and the delivery took place during duty time for several women, especially multiparous and non-obese women. The catheter IOL in an OP setting has gained increased interest. The advantages result mainly from a shorter time in the hospital without compromising the health of the woman or the offspring. This was found in our study, as well as in the meta-analysis by Pierce-Williams[ 10 ]. As for the experience of induction in OP and IP settings, we previously showed that women in OP settings were less satisfied and more anxious than women in IP settings; however, the differences were marginal[ 16 ]. Therefore, IOL in an OP setting is a viable option in low-risk full-term pregnancies. In our study, starting IOL with a catheter during office hours in the morning and early afternoon were more likely to lead to duty time deliveries, especially in multiparous and non-obese women. This kind of procedure may have disadvantages. Healthcare workers have shown to have lower alertness and performance during night shifts[ 6 ]. Furthermore, adverse perinatal outcomes are more frequent in evening and night-time deliveries compared to daytime deliveries[ 17 ]. Moreover, evening and night-time deliveries have been associated with a higher prevalence of new-born infections and the need for admission to an intensive care unit[ 7 ]. As for surgery, night-time surgery was associated more often with intraoperative adverse events and postoperative pulmonary complications[ 18 ], and with increased postoperative mortality and morbidity[ 19 ]. The association between the clock time of delivery and maternal experience of labor has also been explored. In a large retrospective study, primiparous delivery at night was reported as a worse labor experience than delivery during office hours. However, multiparous delivery at night was reported as a better labor experience than delivery in the evening[ 20 ]. Labor timing is generally assumed to be beyond the control of physicians. However, a degree of control is possible when using IOL. Only a few studies have investigated optimal daytime delivery. A Swedish retrospective study with 732 women found fewer night-time deliveries when a catheter was inserted for primiparous women after 6 pm[ 21 ]. Miller et al. used vaginal prostaglandin and achieved optimal daytime delivery when IOL was started at 7 pm in primiparous and 11 pm in multiparous women[ 21 ]. Furthermore, a morning oxytocin start time for multiparous patients showed a lower risk of night-time delivery in one retrospective cohort study[ 23 ]. However, a recent Cochrane review showed no evidence of the superiority of morning versus evening oxytocin induction[ 3 ]. Earlier studies have found that the IOL rate is higher in overweight women than in normal weight women, and that obese women have also an increased rate of failing IOL[ 14 ]. This failure may be due to differences in the myometrium, leading to decreased contraction strength[ 25 , 26 ]. In a cohort study of 15 259 obese primiparous women, time between IOL and delivery was longer than in normal weight women[ 27 ]. Our results confirmed these findings, since in our obese women, measured times were longer than in non-obese women. Nevertheless, using dinoprostone for IOL, Zhao et al. did not find any associations between BMI and IOL delivery interval times[ 28 ]. It is noteworthy, however, that our results may be false-positive biased by a small number of women in the obese group. Our study had benefits but also some limitations. A strength of our study is the prospective randomised design of the trial. Our sample size was only moderate but large enough to show differences according to parity. We enrolled healthy women with uncomplicated full-term pregnancies. Therefore, our results may not be representative of women with chronic diseases, pregnancy complications or preterm delivery induction. In addition, in some of the women, prostaglandin or oxytocin was also used after the catheter, which could have shortened the time intervals. Conclusion Our study showed that setting of catheter IOL did not compromise either the time intervals or the clock times of delivery. Instead, maternal characteristics, namely parity and obesity, showed importance. As expected, both primiparous and obese women had longer labor time intervals. In addition, especially in multiparous women, office time IOL led to duty time delivery. Our results will be helpful in guiding the optimal timing of IOL. Abbreviations ANOVA, analysis of variance; BMI, body mass index; CI, confidence interval; CTG, cardiotocography; gwk, gestational week; IOL, induction of labor; IP, inpatient; OP, outpatient; Q1, lower quartile; Q3, upper quartile; SD, standard deviation; uApH, umbilical arterial pH; uVpH, umbilical venous pH. Declarations Contributions: Kirsi Rinne is the principal investigator and author of the paper. Päivi Polo-Kantola is the leader of the study and co-author of the paper and Henna Lähde is the co-investigator. Terhi Kolari performed the statistical analyses for this study. Ethical Approval: The Turku University Central Hospital Ethics Committee gave approval to the study (3/1801/2016 and 40/1801/2017) and written informed consent was obtained from each patient after oral and written information. This clinical trial was registered at clinicaltrials.gov (NCT02793609). Conflicts of interest: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Funding: The study was financially supported by Turku University Hospital (EVO grant). References Martin JA, Hamilton BE, Osterman M (2021) Births in the United States. NCHS Data Brief:1-8. Gissler M .Finnish medical birth register (2023) Institute of health and welfare of Finland, Statistical report. https://urn.fi/URN:NBN:fi-fe20231103143200. Bakker JJ, van der Goes BY et al (2013) Morning versus evening induction of labour for improving outcomes. Review. Cochrane Database Syst Rev 28 (2):CD007707. doi: 10.1002/14651858.CD007707.pub2. Pinheiro RL, Areia AL, Mota Pinto A, Donato H (2019) Advantage maternal age: Adverse outcomes of pregnancy, A meta-analysis. Acta Med Port 32(3):219-26. doi: 10.20344/amp.11057. Lydon-Rochelle MT, Cardenas V, Nelson JC, Holt VL, Gardella C, Easterling TR (2007) Induction of labor in absence of standard medical indications: incidence and correlates. Med Care 45:505-12. doi: 10.1097/MLR.0b013e3180330e26. Ganesan S, Magee M, Kivi JE, et al (2019) The impact of shift work on sleep, alertness and performance in healthcare workers. Sci Rep 9(1):4635. doi: 10.1038/s 41598-019-40914-x. Montgomery VL (2007) Effect of fatigue, workload, and environment on patient safety in pediatric intensive care unit. Pediatr Crit Care Med 8(2 Suppl):S11-16. doi: 10.1097/01.PCC.0000257735.49562.8F. Di Muzio M, Dionisi S, Di Simone E, et al (2019) Can nurses’ shift work jeopardize the patient safety? A systematic review. Eur Rev Med Pharmacol Sci 23:4507-19. doi:10.2635 /eurrev_201905_17963. de Graaf JP, Ravelli AC, Visser GH et al (2010) Increased adverse perinatal outcome of hospital delivery at night. BJOG 177(9):1098-107. doi:org/10.1111/j.1471-0528.2010.02611. 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J Matern Fetal Neonatal Med 29(4):517-22. doi: 10.3109/14767058.2015.1011117. Namaky DD, Franzese JM, Eschenbacher MA (2015) Timing of induction of labor and association with nighttime delivery: A retrospective cohort. J Perinatol 35(12):1011-4. doi: 10.1038/jp.2015.135. Ruhstaller K (2015) Induction of labor in the obese patient. Semin Perinatol 39:437-40. doi: 10.1053/j.semperi.2015.07.003. Ashraf R, Maxwell C, D´Souza R (2022) Induction of labour in pregnant individuals with obesity. Best Pract Res Clin Obstet Gynecol 79:70-80. doi: 10.1016/j.bpobgyn. 2021.12.004. Carlhäll S, Källen K, Blomberg M (2020) The effect of maternal body mass index on duration of labor. Acta Obstet Gynecol Scand 99:669–678. doi: 10.1111/aogs.13795. Zhao L, Lin Y, Jiang T, Wang L et al (2019) prediction of the induction to delivery time interval in vaginal dinoprostone-induced labor: retrospective study in Chinese tertiary maternity hospital. J Intern Med Res. Tables Tables are available in the Supplementary Files section. Supplementary Tables Supplementary Tables are not available with this version Supplementary Files TABLE1.RinneetalV2.pdf Table 1. Characteristics of participants. TABLE2.RinneetalV2.pdf Table 2. Time intervals of labor (n=108). TABLE3.RinneetalV2.pdf Table 3. Clock times: insertion of the catheter and delivery. Cite Share Download PDF Status: Posted Version 1 posted 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. 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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-5199780","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":375269923,"identity":"ed5c48ed-b561-4fe9-aeb1-b8fbda31f61a","order_by":0,"name":"Kirsi Marja Rinne","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA3ElEQVRIiWNgGAWjYBACCWYgkcDAwAOkGB+AmcwHG4jWwmxwAMRkSySgBYnNJgHRkoDfYZLtvI8/PGC4J2Mu3Xys+mNbmj0DGzN+W6SZ2c0kEhiKeSznHEu7cbAtJ7GBjRG/FjlmNjagaxJ4DG7kmAG1VCQwyDcS1ML8AaIl/1sBUAvQYQRskWZmY5CA2sLGAHQYI0GHSTazsUkkGIC0pBlLnDmXlthGSIvE+WPMH39UJNgb3Eh++KGiLNmen439AV4tEGAApRnZgNFChHpk8IdE9aNgFIyCUTAiAAAvDT24M+tFtQAAAABJRU5ErkJggg==","orcid":"https://orcid.org/0000-0001-7740-2380","institution":"Turku University Hospital: TYKS Turu yliopistollinen keskussairaala","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Kirsi","middleName":"Marja","lastName":"Rinne","suffix":""},{"id":375269924,"identity":"b4ea06b4-9c71-48fd-86c4-36b6a4c10862","order_by":1,"name":"Henna Lähde","email":"","orcid":"","institution":"Turku University Hospital: TYKS Turu yliopistollinen keskussairaala","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Henna","middleName":"","lastName":"Lähde","suffix":""},{"id":375269925,"identity":"4c2d0168-fa25-49fc-baf9-ef0accd38d07","order_by":2,"name":"Terhi Kolari","email":"","orcid":"","institution":"Turku University Hospital: TYKS Turu yliopistollinen keskussairaala","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Terhi","middleName":"","lastName":"Kolari","suffix":""},{"id":375269926,"identity":"60c8c398-e0e7-4917-8094-64ff4353d00f","order_by":3,"name":"Päivi Polo","email":"","orcid":"","institution":"Turku University Hospital: TYKS Turu yliopistollinen keskussairaala","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Päivi","middleName":"","lastName":"Polo","suffix":""}],"badges":[],"createdAt":"2024-10-03 17:27:22","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5199780/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5199780/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":69940849,"identity":"8a90a1f6-82f1-473b-ad4c-0539a3a64754","added_by":"auto","created_at":"2024-11-26 21:08:49","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":94784,"visible":true,"origin":"","legend":"\u003cp\u003eConsort flowchart of the study.\u003c/p\u003e","description":"","filename":"Figure1.Rinne.png","url":"https://assets-eu.researchsquare.com/files/rs-5199780/v1/9668ffafbee56d8de95d020c.png"},{"id":69940529,"identity":"ded21c18-45a1-4b4d-8009-36eb1ae5349a","added_by":"auto","created_at":"2024-11-26 21:00:49","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":75186,"visible":true,"origin":"","legend":"\u003cp\u003eGroup and individual induction of labor (IOL) – delivery times in primiparous (a) and multiparous women (b).\u003c/p\u003e","description":"","filename":"Figure2.pngyhdistetty.png","url":"https://assets-eu.researchsquare.com/files/rs-5199780/v1/4f9c84556e53fe3755e20303.png"},{"id":69941014,"identity":"cda5b007-a7e6-4a8a-bef9-85a0bfc0f930","added_by":"auto","created_at":"2024-11-26 21:16:51","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":467931,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5199780/v1/62785ce0-bbba-49c6-a76d-be056a513796.pdf"},{"id":69940530,"identity":"38f607b3-62a6-4471-bd39-4545ff07d709","added_by":"auto","created_at":"2024-11-26 21:00:49","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":12489,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eTable 1.\u003c/strong\u003e Characteristics of participants.\u003c/p\u003e","description":"","filename":"TABLE1.RinneetalV2.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5199780/v1/0e999d2b263b3b27b7f55f27.pdf"},{"id":69940533,"identity":"e152114f-5aa1-4ac0-98bf-27b763afe6d1","added_by":"auto","created_at":"2024-11-26 21:00:49","extension":"pdf","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":76861,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eTable 2. \u003c/strong\u003eTime intervals of labor (n=108).\u003c/p\u003e","description":"","filename":"TABLE2.RinneetalV2.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5199780/v1/ef368d9e374fd72e76a912d4.pdf"},{"id":69940532,"identity":"1249692d-b9b3-41bc-a669-11f682b8795a","added_by":"auto","created_at":"2024-11-26 21:00:49","extension":"pdf","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":71085,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eTable 3. \u003c/strong\u003eClock times: insertion of the catheter and delivery.\u003c/p\u003e","description":"","filename":"TABLE3.RinneetalV2.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5199780/v1/49e5252e3eae1faf5fb3f509.pdf"}],"financialInterests":"","formattedTitle":"Timing of induction of labor with catheter – a prospective randomized study with special reference to setting, parity and obesity","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThe frequency of induction of labor (IOL) is rising word wide. In the United States, more than 30% of deliveries were induced in 2020[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. The IOL rate in Finland was 35% in 2022, which was higher than ever before[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Increasing maternal age, obesity and co-morbidities during pregnancy have added pregnancy complications and thus, increased the need for IOL[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Furthermore, IOL is occasionally carried out because for logistic reasons (e.g. long distance to the hospital), social reasons (e.g. family problems) or the request of the pregnant woman[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. The aim of successful IOL is to reduce the pregnancy complications, shorten the induction to delivery interval, achieve vaginal delivery, and healthy new-borns.\u003c/p\u003e \u003cp\u003eIOL is typically planned electively during office hours. However, this procedure may, at least partly, lead to duty time deliveries, which is typically a time when personnel is scanter. In addition, a decrease in alertness and performance is evident during duty time and night shift work[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e], which may lead to increased errors[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] and thus presumably to perinatal adverse outcomes[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eOptimising the outcome of planned delivery often involves labor during office hours. However, few previous studies have assessed the time intervals during IOL or evaluated the optimal time of day for IOL[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. In a meta-analysis with 8 trials, no difference between Foley catheter and prostaglandins was found in the median time to delivery[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. However, Foley catheter is much cheaper than vaginal used prostaglandins[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. As for setting of IOL, the outpatient (OP) group with catheter spent a shorter time in hospital than the inpatient (IP) group, with a median difference of 7.2 hours[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Furthermore, in a randomised study by Policiano et al. with OP and IP settings, the average total IOL-to-delivery time was shorter in the OP group than in the IP group[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Also, several maternal characteristics may interfere with the duration of IOL, most probably parity and body mass index (BMI). In general, multiparous women have shorter IOL-delivery times than primiparous women[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e], and in obese women risk for failing IOL is increased[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe principal aim of our prospective randomized study was to evaluate the time intervals of catheter IOL in OP and IP settings. As the secondary aim, we assessed the effects of parity and obesity on the time intervals. We were especially interested in whether women with office time inductions more often have duty time deliveries.\u003c/p\u003e"},{"header":"Material and methods","content":"\u003cp\u003eThis study was part of a prospective randomised controlled IOL study performed between July 2016 and December 2019 at Turku University Hospital, Finland. Pregnant women who entered the department for a planned induction of labor and volunteered for the study were enrolled. The inclusion criteria were singleton-term pregnancy in gestational week (gwk) 37\u0026ndash;41\u0026thinsp;+\u0026thinsp;5, cephalic presentation, intact membranes, a Bishop score\u0026thinsp;\u0026lt;\u0026thinsp;6, normal cardiotocography (CTG), sufficient knowledge of Finnish to fill in the study questionnaire and short distance to the hospital (at most half an hour drive). Exclusion criteria included any severe pregnancy complications (e.g. hypertensive pregnancy, medically treated gestational diabetes, intrauterine growth restriction, signs of fetal distress).\u003c/p\u003e \u003cp\u003eCervix status was examined by a gynecological examination and transvaginal ultrasound. A double-balloon catheter (the Cook\u0026reg;, Cervical Ripening Balloon Catheter J-CRBS-184000) was used for IOL. As a routine, both balloons were filled in with 80ml saline, unless causing constant pain: in that case, part of the saline, mostly from the lower balloon, was emptied. In six cases, where IOL was performed by physicians not involved in the study by change, only single balloon catheter with 60-80ml filling were used (two in the OP group and four in the IP group). However, single balloon catheter has previously shown to be at least comparable to double balloon catheter in terms of vaginal birth rate and maternal and perinatal safety outcomes[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Thereafter, the women were randomised to either the OP or IP group. Randomization was conducted by a professional statistician using a computer-generated random number list, and the codes were placed in sequentially numbered, sealed opaque envelopes.\u003c/p\u003e \u003cp\u003eThe sample size was initially calculated to detect a significant difference in satisfaction scores on the VAS scale between outpatient and inpatient groups, as satisfaction was the primary outcome for our original study[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. For the purpose of this analysis, sample size adequacy was re-evaluated with duration as the outcome variable. Using the observed standard deviation in duration from our study and aiming for 80% power, a sample size of 37 subjects per group would have been sufficient to detect a two-hour difference between groups. Actual sample sizes of n\u0026thinsp;=\u0026thinsp;53 and n\u0026thinsp;=\u0026thinsp;55 per group provide approximately 93% power for this analysis.\u003c/p\u003e \u003cp\u003eAltogether 117 women with planned IOL were enrolled. Nine women withdrew from the study after randomisation and thus: four wanted another than the randomised, 108 women were included in the study: 53 women in the OP group and 55 in the IP group (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). Catheter insertion was performed in 73.1% (n\u0026thinsp;=\u0026thinsp;79/108) of the women between 8 am and 12 am and in 26.9% (n\u0026thinsp;=\u0026thinsp;29/108) between 12 am and 4 pm.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eBasic characteristics, including parity (primiparous/multiparous), gwk, body mass index (BMI, kg/m\u003csup\u003e2\u003c/sup\u003e), Bishop score and cervix length (mm) by ultrasound were collected from patients\u0026rsquo; files (Table\u0026nbsp;1). Two additional groups of interest were formed: parity (primiparous and multiparous) and body mass index (BMI, \u0026le;\u0026thinsp;30 kg/m\u003csup\u003e2\u003c/sup\u003e\u0026thinsp;=\u0026thinsp;non-obese and \u0026gt;\u0026thinsp;30 kg/m\u003csup\u003e2\u003c/sup\u003e\u0026thinsp;=\u0026thinsp;obese). The information about the delivery and new-born outcomes are presented in Supplementary Tables\u0026nbsp;1 and 2. After randomisation and CTG control, the women in the OP group were discharged with written instructions regarding OP induction, and the women in the IP group stayed at the hospital. The women in both groups were instructed by midwifes how to pull catheter outwards once an hour.\u003c/p\u003e \u003cp\u003eThe time between discharge and re-admittance of all women in the OP group was assessed. Five time intervals of labor were evaluated: 1) insertion to expulsion of catheter (insertion\u0026ndash;expulsion time), 2) expulsion of catheter to delivery (expulsion\u0026ndash;delivery time), 3) amniotomy to delivery (amniotomy\u0026ndash;delivery time), 4) IOL to delivery (IOL\u0026ndash;delivery time) and 5) the total time in the hospital (total admission time). All these times were analysed in three groups: between the OP and IP groups, between the primiparous and multiparous groups, and between the obese and non-obese groups. In addition, the clock times of the insertion of the catheter and delivery were evaluated in all group comparisons.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analyses\u003c/h2\u003e \u003cp\u003eFirst, the distributions of all variables were visually evaluated to select appropriate descriptive statistics and statistical tests. Normally distributed variables are reported with means and standard deviations (SDs), and analysis of variance (ANOVA) was used to compare the groups. Skewed distributions are reported with medians and lower (Q1) and upper quartiles (Q3). Wilcoxon rank sum tests were performed to compare the groups. Categorical variables are summarised with frequencies and percentages. Associations between categorical variables were tested with a Chi-squared test.\u003c/p\u003e \u003cp\u003eThe time intervals were analysed as continuous, except the IOL\u0026ndash;delivery time was considered both continuous and categorical (\u0026lt;\u0026thinsp;24 hours/ \u0026ge;24 hours \u0026ndash; \u0026le;48 hours/\u0026gt;48 hours). All time intervals were calculated as median survival times with 95% confidence intervals (CIs) using the Kaplan\u0026ndash;Meier approach, and the groups were compared using the log-rank test. In contrast, quantile regression was used to calculate the differences in the medians with 95% CIs and \u003cem\u003eP\u003c/em\u003e-values. The associations between categorical IOL delivery times and setting, parity and BMI groups were analysed using Chi-squared tests. The significance level was set at 0.05. All tests were performed as two-sided. The data were collected using IBM SPSS Statistics version 27, and all analyses were performed using SAS (Version 9.4) for Windows. Graphs were constructed in R version 4.2.1 using the ggplot2 package.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eAll women\u003c/h2\u003e \u003cp\u003eThe time intervals for all women are shown in Table\u0026nbsp;2 and Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. The median IOL\u0026ndash;delivery time of all women was 30.2 hours (95%CI 27.0\u0026ndash;35.4) and the median expulsion\u0026ndash;delivery time was 15.2 hours (95%CI 12.3\u0026ndash;18.5 hours). The median IOL\u0026ndash;delivery time was 28.2 hours (95%CI 22.1\u0026ndash;32.0; n\u0026thinsp;=\u0026thinsp;87) in women who had a vaginal delivery and 49.1 hours (95%CI 32.0\u0026ndash;67.7; n\u0026thinsp;=\u0026thinsp;21) in women who had a cesarean section. The median total time in the hospital was 4.1 days (95%CI 3.5\u0026ndash;4.6). Of all women studied, 42.6% (n\u0026thinsp;=\u0026thinsp;46) delivered between 6 am and 6 pm, and 57.4% (n\u0026thinsp;=\u0026thinsp;62) delivered between 6 pm and 6 am (Table\u0026nbsp;3).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eComparison between the OP and IP groups\u003c/h3\u003e\n\u003cp\u003eIn the OP group, the median time between discharge and re-admittance with the catheter was 17.5 hours (95%CI 10.6\u0026ndash;19.7 hours). Of the women in the OP group, 20 (37.7%) returned to the hospital before the scheduled time. Eighteen women returned because of the expulsion of the catheter; one woman had contractions that were too painful, and one had broken membranes.\u003c/p\u003e \u003cp\u003eBetween the OP and IP groups, there were no differences in insertion\u0026ndash;expulsion times, expulsion\u0026ndash;delivery times, amniotomy\u0026ndash;delivery times or IOL\u0026ndash;delivery times (Table\u0026nbsp;2, Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The total time in the hospital was 28.3 hours (95%CI 6.7\u0026ndash;49.9) longer in the IP group (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.011). In the OP and IP groups, the catheter was inserted between 8 am and 12 am in 69.8% (n\u0026thinsp;=\u0026thinsp;37) and 76.4% (n\u0026thinsp;=\u0026thinsp;42), respectively (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.371), and between 12 am and 4 pm in 30.2% (n\u0026thinsp;=\u0026thinsp;16) and 23.6% (n\u0026thinsp;=\u0026thinsp;13), respectively (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;1.00). Of the women, 54.7% (n\u0026thinsp;=\u0026thinsp;29) in the OP group and 60.0% (n\u0026thinsp;=\u0026thinsp;33) in the IP group delivered between 6 pm and 6 am, while 45.3% (n\u0026thinsp;=\u0026thinsp;24) in the OP group and 40.0% (n\u0026thinsp;=\u0026thinsp;22) in the IP group delivered between 6 am and 6 pm (Table\u0026nbsp;3). The frequency distribution did not differ between the groups (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.579). There were no differences in the delivery or new-born outcomes between the groups (Supplementary Tables\u0026nbsp;1 and 2).\u003c/p\u003e\n\u003ch3\u003eComparisons between primiparous and multiparous women\u003c/h3\u003e\n\u003cp\u003eIn primiparous women, the median insertion\u0026ndash;expulsion time was 10.2 hours longer than in multiparous women (95%CI 5.9\u0026ndash;14.4; \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.0001). The expulsion\u0026ndash;amniotomy time did not differ (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.42). Compared to multiparous women, the median amniotomy\u0026ndash;delivery time was 8.2 hours longer (95%CI 4.0\u0026ndash;12.3; \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.0001) and the median IOL\u0026ndash;delivery time was 17.0 hours longer (95%CI 9.4\u0026ndash;24.6; \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.0001) in primiparous women. The median expulsion\u0026ndash;delivery time was 19.8 hours (95%CI 14.8\u0026ndash;25.1) in primiparous women and 10.0 hours (95%CI 7.7\u0026ndash;12.4) in multiparous women (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.0005) (Table\u0026nbsp;2, Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe group and individual IOL delivery times are illustrated in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. The IOL delivery time was under 24 hours in 18.2% and 59.5%, between 24 and 48 hours in 48.5% and 28.6%, and over 48 hours in 33.3% and 11.9% of primiparous and multiparous women, respectively (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.0001, Table\u0026nbsp;4). The majority of the catheters (73.1%, n\u0026thinsp;=\u0026thinsp;79/108) were inserted between 8 am and 12 pm; accordingly, 50.9% (n\u0026thinsp;=\u0026thinsp;26) of primiparous and 64.3% (n\u0026thinsp;=\u0026thinsp;18) of multiparous women delivered between 6 pm and 6 am. When the catheter was inserted between 12 pm and 4 pm, 73.3% (n\u0026thinsp;=\u0026thinsp;11) of primiparous and 71.4% (n\u0026thinsp;=\u0026thinsp;10) of multiparous delivered between 6 pm and 6 am (Table\u0026nbsp;3).\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eComparison between obese and non-obese groups\u003c/h2\u003e \u003cp\u003eCompared to the non-obese group, the expulsion\u0026ndash;delivery time, amniotomy\u0026ndash;delivery time and IOL\u0026ndash;delivery time were 13.9 hours (95%CI 3.1\u0026ndash;30.9; \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.0017), 9.8 hours (95%CI 0.8\u0026ndash;32.5; \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.004) and 15.9 hours longer (95%CI 0.8\u0026ndash;32.5; \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.061), respectively, for obese women. The total hospital time was more than one day longer (95%CI 0.05\u0026ndash;2.2; \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.041) for obese women (Table\u0026nbsp;2).\u003c/p\u003e \u003cp\u003eIn primiparous women, the median IOL\u0026ndash;delivery time was 34.4 hours among non-obese women (n\u0026thinsp;=\u0026thinsp;51, 95%CI 28.8\u0026ndash;39.1) and 49.1 hours among obese women (95%CI 32.0\u0026ndash;61.2, n\u0026thinsp;=\u0026thinsp;15). In multiparous, the median IOL\u0026ndash;delivery time was 21.3 hours in non-obese women (95%CI 15.0\u0026ndash;26.6, n\u0026thinsp;=\u0026thinsp;37) and 20.0 hours in obese women (95%CI 13.4\u0026ndash;NA, n\u0026thinsp;=\u0026thinsp;5).\u003c/p\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eAccording to our study, regarding the setting, the only difference was the shorter total time in hospital in the OP group, which was expected. Nevertheless, the clock time of delivery was not dependent on the setting. Instead, the time intervals differed on one hand in comparisons between primiparous and multiparous women and on the other hand in comparisons between obese and non-obese women. Both multiparous and non-obese women had shorter time intervals. As the women in our study were enrolled among those with planned IOL, for logistical reasons, the catheters were mainly inserted during office hours, and the delivery took place during duty time for several women, especially multiparous and non-obese women.\u003c/p\u003e \u003cp\u003eThe catheter IOL in an OP setting has gained increased interest. The advantages result mainly from a shorter time in the hospital without compromising the health of the woman or the offspring. This was found in our study, as well as in the meta-analysis by Pierce-Williams[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. As for the experience of induction in OP and IP settings, we previously showed that women in OP settings were less satisfied and more anxious than women in IP settings; however, the differences were marginal[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. Therefore, IOL in an OP setting is a viable option in low-risk full-term pregnancies.\u003c/p\u003e \u003cp\u003eIn our study, starting IOL with a catheter during office hours in the morning and early afternoon were more likely to lead to duty time deliveries, especially in multiparous and non-obese women. This kind of procedure may have disadvantages. Healthcare workers have shown to have lower alertness and performance during night shifts[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Furthermore, adverse perinatal outcomes are more frequent in evening and night-time deliveries compared to daytime deliveries[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Moreover, evening and night-time deliveries have been associated with a higher prevalence of new-born infections and the need for admission to an intensive care unit[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. As for surgery, night-time surgery was associated more often with intraoperative adverse events and postoperative pulmonary complications[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e], and with increased postoperative mortality and morbidity[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. The association between the clock time of delivery and maternal experience of labor has also been explored. In a large retrospective study, primiparous delivery at night was reported as a worse labor experience than delivery during office hours. However, multiparous delivery at night was reported as a better labor experience than delivery in the evening[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eLabor timing is generally assumed to be beyond the control of physicians. However, a degree of control is possible when using IOL. Only a few studies have investigated optimal daytime delivery. A Swedish retrospective study with 732 women found fewer night-time deliveries when a catheter was inserted for primiparous women after 6 pm[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Miller et al. used vaginal prostaglandin and achieved optimal daytime delivery when IOL was started at 7 pm in primiparous and 11 pm in multiparous women[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Furthermore, a morning oxytocin start time for multiparous patients showed a lower risk of night-time delivery in one retrospective cohort study[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. However, a recent Cochrane review showed no evidence of the superiority of morning versus evening oxytocin induction[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eEarlier studies have found that the IOL rate is higher in overweight women than in normal weight women, and that obese women have also an increased rate of failing IOL[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. This failure may be due to differences in the myometrium, leading to decreased contraction strength[\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. In a cohort study of 15 259 obese primiparous women, time between IOL and delivery was longer than in normal weight women[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. Our results confirmed these findings, since in our obese women, measured times were longer than in non-obese women. Nevertheless, using dinoprostone for IOL, Zhao et al. did not find any associations between BMI and IOL delivery interval times[\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. It is noteworthy, however, that our results may be false-positive biased by a small number of women in the obese group.\u003c/p\u003e \u003cp\u003eOur study had benefits but also some limitations. A strength of our study is the prospective randomised design of the trial. Our sample size was only moderate but large enough to show differences according to parity. We enrolled healthy women with uncomplicated full-term pregnancies. Therefore, our results may not be representative of women with chronic diseases, pregnancy complications or preterm delivery induction. In addition, in some of the women, prostaglandin or oxytocin was also used after the catheter, which could have shortened the time intervals.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eOur study showed that setting of catheter IOL did not compromise either the time intervals or the clock times of delivery. Instead, maternal characteristics, namely parity and obesity, showed importance. As expected, both primiparous and obese women had longer labor time intervals. In addition, especially in multiparous women, office time IOL led to duty time delivery. Our results will be helpful in guiding the optimal timing of IOL.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eANOVA, analysis of variance; BMI, body mass index; CI, confidence interval; CTG, cardiotocography; gwk, gestational week; IOL, induction of labor; IP, inpatient; OP, outpatient; Q1, lower quartile; Q3, upper quartile; SD, standard deviation; uApH, umbilical arterial pH; uVpH, umbilical venous pH.\u003c/p\u003e\n"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eContributions:\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;Kirsi Rinne is the principal investigator and author of the paper. P\u0026auml;ivi Polo-Kantola is the leader of the study and co-author of the paper and Henna L\u0026auml;hde is the co-investigator. Terhi Kolari performed the statistical analyses for this study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003cstrong\u003eEthical Approval:\u003cbr\u003e\u0026nbsp;\u003c/strong\u003eThe Turku University Central Hospital Ethics Committee gave approval to the study (3/1801/2016 and 40/1801/2017) and written informed consent was obtained from each patient after oral and written information. This clinical trial was registered at clinicaltrials.gov (NCT02793609).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eConflicts of interest:\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eFunding:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was financially supported by Turku University Hospital (EVO grant).\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eMartin JA, Hamilton BE, Osterman M (2021) Births in the United States. NCHS Data Brief:1-8.\u003c/li\u003e\n\u003cli\u003eGissler M .Finnish medical birth register (2023) Institute of health and welfare of Finland, Statistical report. https://urn.fi/URN:NBN:fi-fe20231103143200.\u003c/li\u003e\n\u003cli\u003eBakker JJ, van der Goes BY et al (2013) Morning versus evening induction of labour for improving outcomes. Review. Cochrane Database Syst Rev\u003cem\u003e \u003c/em\u003e28 (2):CD007707. doi: 10.1002/14651858.CD007707.pub2.\u003c/li\u003e\n\u003cli\u003ePinheiro RL, Areia AL, Mota Pinto A, Donato H (2019) Advantage maternal age: Adverse outcomes of pregnancy, A meta-analysis. Acta Med Port 32(3):219-26. doi: 10.20344/amp.11057.\u003c/li\u003e\n\u003cli\u003e\u003cem\u003e Lydon-Rochelle MT, Cardenas V, Nelson JC, Holt VL, Gardella C, Easterling TR (2007) Induction of labor in absence of standard medical indications: incidence and correlates. Med Care 45:505-12. doi: 10.1097/MLR.0b013e3180330e26.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003e\u003cem\u003e Ganesan S, Magee M, Kivi JE, et al (2019) The impact of shift work on sleep, alertness and performance in healthcare workers. Sci Rep 9(1):4635. doi: 10.1038/s 41598-019-40914-x.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eMontgomery VL (2007) Effect of fatigue, workload, and environment on patient safety in pediatric intensive care unit. Pediatr Crit Care Med 8(2 Suppl):S11-16. doi: 10.1097/01.PCC.0000257735.49562.8F.\u003c/li\u003e\n\u003cli\u003eDi Muzio M, Dionisi S, Di Simone E, et al (2019) Can nurses\u0026rsquo; shift work jeopardize the patient safety? A systematic review. Eur Rev Med Pharmacol Sci\u003cem\u003e \u003c/em\u003e23:4507-19. doi:10.2635 /eurrev_201905_17963.\u003c/li\u003e\n\u003cli\u003ede Graaf JP, Ravelli AC, Visser GH et al (2010) Increased adverse perinatal outcome of hospital delivery at night. BJOG 177(9):1098-107. doi:org/10.1111/j.1471-0528.2010.02611.\u003c/li\u003e\n\u003cli\u003ePierce-Williams RD, Lesser H, Saccone G, et al (2022) Outpatient cervical ripening with balloon catheters: A systematic review and meta-analysis. Obstet Gynelocol 139(2):255-68. doi: 10.1097/AOG.0000000000004644.\u003cem\u003e \u003c/em\u003e\u003c/li\u003e\n\u003cli\u003ePatabendinge M, Jayawardane A (2017) Foley catheter for vervical priming in induction of labour at University Obstetrics Unit, Colombo, Sri lanka: a clinical audit with a patient satisfaction survey. BMC Res Notes 10:155.doi: 10.1186/s13104-017-2478-z.\u003c/li\u003e\n\u003cli\u003ePoliciano C, Pimenta M, Martins D, Clode N (2017) Outpatient versus inpatient cervix priming with Foley catheter: A randomized trial. Eur J Obstet Gynecol Reprod Biol\u003cem\u003e \u003c/em\u003e210:1-6. doi: 10.1016/j.ejogrb.2016.11.026.\u003c/li\u003e\n\u003cli\u003eHarper LM, Caughey AB, Odibo AO, Roehl KA, Zhao Q et al (2012) Normal progress of induced labor. Obstet Gynecol\u003cem\u003e \u003c/em\u003e119:1113-1118. doi:10.1097/ AOG.0b013 e318253d7 aa.PMID: 22569121.\u003c/li\u003e\n\u003cli\u003eWolfe KB, Rossi RA, Warshak CR (2011) The effect of maternal obesity on the rate of failed induction of labor. Am J Obstet Gynecol 205(2):128.e1-e7. doi.org/ 10.1016 /j.ajog. 2011.03.051.\u003c/li\u003e\n\u003cli\u003ePeel MD, Croll DM, Kessler J, Haugland B, Pennell CE, Dickinson JE, Li W (2023)\u003cem\u003e \u003c/em\u003eActa Obstet\u003cem\u003e \u003c/em\u003eGynecol Scand.\u003cem\u003e 1\u003c/em\u003e02:1440\u0026ndash;1449.\u003c/li\u003e\n\u003cli\u003eHaavisto H, Polo-Kantola P, Anttila E, Kolari T, Ojala E, Rinne K (2020) Experience of induction of labor with a catheter - A prospective randomized controlled trial compering the outpatient and inpatient setting. Acta Obstet Gynecol Scand\u003cem\u003e \u003c/em\u003e100(3):410-17. doi: 10.1111/aogs.14037.\u003c/li\u003e\n\u003cli\u003eGijsen R, Hukkelhoven CW, Schipper CM, Ogbu UC (2012) Effects of hospital delivery during off-hours on perinatal outcome in several subgroups: A retrospective cohort study. BMC\u003cem\u003e \u003c/em\u003ePregnancy Childbirth 12:92. doi: 10.1186/1471-2393-12-92.\u003c/li\u003e\n\u003cli\u003eVidal C, Medeiros M, Andrade J, Araujo Junior E, Carvalho F (2020) Influence of evening/night-time birth on maternal/perinatal outcomes in a low-risk population\u003cem\u003e. \u003c/em\u003eJ Turk Ger Gynecol\u003cem\u003e \u003c/em\u003eAssoc\u003cem\u003e \u003c/em\u003e21:221-7.doi: 10.4274/jtgga.galenos.2020.2020.0081.\u003c/li\u003e\n\u003cli\u003eGortegiani A, Gregoretti C, Neto AS, et al (2019) Association between night-time surgery an occurrence of intraoperative adverse events and postoperative pulmonary complications. BJA\u003cem\u003e \u003c/em\u003e122(3):361-9. doi: 10.1016/j.bja.2020.01.019.\u003c/li\u003e\n\u003cli\u003e\u003cem\u003e Althoff FC, Wachtendorf LJ, Rostin P, et al (2021) Effects of night surgery on postoperative mortality and morbidity: A multicentre cohort study. BMJ\u003cem\u003e \u003c/em\u003e30(8):678-88. doi: 10.1136/bmjqs-2020-011684.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eJoensuu J, Saarij\u0026auml;rvi H, Rouhe H, et al. Maternal childbirth experience and time of delivery: Retrospective 7-year cohort study of 105847 parturients in Finland. BMJ Open 2021; 11:e046433. doi.org/10.1136/dmjopen-2020-046433.\u003c/li\u003e\n\u003cli\u003e\u003cem\u003e Thorsell M, Lyren\u0026auml;s S, Andolf E, Kaijser M (2011) Starting time for induction of labor and the risk for night-time delivery. Sex Reprod Healthc 2(3):113-7. doi: 10.1016/ j.srhc. 2011.05.001.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eMiller H, Goetzl L, Wing D, Powers B, Rugarn O (2016) Optimising daytime deliveries when inducing labour using prostaglandin vaginal inserts.\u003cem\u003e \u003c/em\u003eJ Matern Fetal Neonatal Med\u003cem\u003e \u003c/em\u003e29(4):517-22. doi: 10.3109/14767058.2015.1011117.\u003c/li\u003e\n\u003cli\u003eNamaky DD, Franzese JM, Eschenbacher MA (2015) Timing of induction of labor and association with nighttime delivery: A retrospective cohort. J Perinatol\u003cem\u003e \u003c/em\u003e35(12):1011-4. doi: 10.1038/jp.2015.135.\u003c/li\u003e\n\u003cli\u003eRuhstaller K (2015) Induction of labor in the obese patient.\u003cem\u003e \u003c/em\u003eSemin Perinatol 39:437-40. doi: 10.1053/j.semperi.2015.07.003.\u003c/li\u003e\n\u003cli\u003e\u003cem\u003e Ashraf R, Maxwell C, D\u0026acute;Souza R (2022) Induction of labour in pregnant individuals with obesity. Best Pract Res Clin Obstet Gynecol\u003cem\u003e \u003c/em\u003e79:70-80. doi: 10.1016/j.bpobgyn. 2021.12.004.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003e\u003cem\u003e Carlh\u0026auml;ll S, K\u0026auml;llen K, Blomberg M (2020) The effect of maternal body mass index on duration of labor. Acta Obstet Gynecol Scand\u003cem\u003e \u003c/em\u003e99:669\u0026ndash;678. doi: 10.1111/aogs.13795.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eZhao L, Lin Y, Jiang T, Wang L et al (2019) prediction of the induction to delivery time interval in vaginal dinoprostone-induced labor: retrospective study in Chinese tertiary maternity hospital. J Intern Med Res.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables are available in the Supplementary Files section.\u003c/p\u003e"},{"header":"Supplementary Tables","content":"\u003cp\u003eSupplementary Tables are not available with this version\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"catheter, induction of labor, obesity, outpatient, inpatient, parity, timing","lastPublishedDoi":"10.21203/rs.3.rs-5199780/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5199780/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cem\u003ePurpose:\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eInduction of labor (IOL) is typically performed during office hours, possibly leading to delivery during duty time. We aimed to evaluate timing between IOL with catheter and delivery.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eMethods:\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAltogether, 108 women with planned IOL were included in prospective randomized study. Five different time intervals were evaluated: 1) insertion to expulsion of catheter 2) expulsion of catheter to delivery 3) amniotomy to delivery 4) IOL to delivery and 5) the total admission time by setting (outpatient [OP]/inpatients [IP]), parity (primiparous/multiparous) and body mass index (obese/non-obese).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eResults:\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eFor IOL setting, the time in the hospital was 17.5 hours longer in the IP group, with no other differences. All time intervals were longer for primiparous than for multiparous women. The same was true for obese women, compared to non-obese women, except in the insertion–expulsion time.\u003c/p\u003e\n\u003cp\u003eWhen IOL was performed during office hours, 57.4% of women delivered between 6pm and 6am, and 42.6% between 6am and 6pm (\u003cem\u003eP\u003c/em\u003e=0.124). Furthermore, 66.7% of multiparous and 50.0% of obese women delivered between 6pm and 6am, with no difference between settings.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eConclusions:\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe setting of catheter IOL did not compromise delivery times. Instead, parity and marginally obesity showed importance.\u003c/p\u003e","manuscriptTitle":"Timing of induction of labor with catheter – a prospective randomized study with special reference to setting, parity and obesity","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-11-26 21:00:43","doi":"10.21203/rs.3.rs-5199780/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"d81857a7-677a-4626-b304-5fabd0fa5d18","owner":[],"postedDate":"November 26th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-11-26T21:00:47+00:00","versionOfRecord":[],"versionCreatedAt":"2024-11-26 21:00:43","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5199780","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5199780","identity":"rs-5199780","version":["v1"]},"buildId":"WrCJVZZCHTDjtuVLN7oU0","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}