Efficacy and safety of double balloon catheter and dinoprostone for labor induction in multipara at term

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Methods A retrospective cohort study was conducted among multipara at term with a Bishop score < 6 who needed planned labor induction from January 1, 2020, to December 30, 2020 in Maternal and Child Health Hospital of Hubei province, Tongji Medical College, Huazhong University of Science and Technology. They were divided into DBC group and dinoprostone group respectively. Baseline maternal data, maternal and neonatal outcomes were recorded for statistical analysis. Total vaginal delivery rate, rate of vaginal delivery within 24 h, rate of uterine hyperstimulation combined with abnormal fetal heart rate(FHR) were regarded as the primary outcome variables. The diffrerence between groups was considered statistically significant when p value < 0.05. Results A total of 202 multipara was included for analysis (95 women in DBC group vs 107 women in dinoprostone group ). There were no significant differences in total vaginal delivery rate and rate of vaginal delivery within 24 h between groups. Uterine hyperstimulation combined with abnormal FHR occurred exclusively in dinoprostone group. Conclusion DBC and dinoprostone seem to be equally effective, and DBC seems to be safer than dinoprostone as it causes lower rate of uterine hyperstimulation combined with abnormal FHR. Multipara double balloon catheter dinoprostone induction of labor vaginal delivery Figures Figure 1 Introduction Induction of labor (IOL) is an obstetrical procedure that has been increasingly used in recent years. The proportion of people experiencing IOL increased by nearly 10% from 2007 to 2017, with IOL rate exceeding 25.5% (1 in 4) in 2017 [ 1 ] . With the implementation of two-child policy, the rate of labor induction at term has been increased to more than 30% in 2013 in China [ 2 ] . Following the publication of the ARRIVE trial [ 3 ] and the implementation of three-child policy, the IOL rate is expected to rise in the future in China. For women with an unfavorable cervix (Bishop score < 6) [ 4 – 6 ] , the additional step of cervical ripening is required during induction of labor. There are mechanical and pharmacologic methods of cervical ripening. Approved by the United States Food and Drug Administration (FDA) in 2013, the Cook Cervical Ripening Balloon (Cook Inc; Bloomington, IN) can lead to cervical ripening by either direct mechanical dilation of the cervix or stimulation of prostaglandin released from the amnion, chorion, and decidua [ 7 , 8 ] . Dinoprostone is chemically identical to endogenous prostaglandin E2 (PGE2), which has been approved by the FDA for cervical ripening and has been widely used in several countries throughout the world. There have been many studies comparatively studying the effectiveness and safety of the two labor induction methods [ 9 – 13 ] . It is well known that the history of vaginal delivery itself is of vital importance for the success of induction, but the vast majority of studies have focused on primipara or have not fully distinguished between primipara and multipara. However, the optimal method for labor induction for multipara at term with an unfavorable cervix remains unknown. In this retrospective cohort study conducted in our birth centre from January 1, 2020, to December 30, 2020, the efficacy and safety of DBC and dinoprostone as labor-inducing agents for multipara were comparatively analyzed. Materials And Methods Ethical approval and patient consent The study protocol was approved by the Ethics Committee of Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology ([2019] IEC (XM008)). All included women signed written informed consent for therapeutic procedures and for the publication of those reports. Selection of patients and study design The flowchart of the experimental design is shown in Figure 1 . In this retrospective cohort study, a total of multiparas aged 18 to 50 years with gestational ages ≥37 weeks, who had history of vaginal delivery, singleton gestation, vertex presentation, intact membranes, normal preinduction fetal heart rate tracing, Bishop score <6, fetal weight of less than 4500 grams with a ultrasound or clinical estimated were included. The exclusion criteria were pregnant women aged less than 18 years or older than 50 years, primipara, cesarean section. During the observation period at our birth centre from January 1st, 2020 to December 30th, 2020, a total of 252 multiparas were enrolled in this study. Among them, 4 cases with data exceptions, 18 cases with Bishop scores ≥6, 6 cases with gestation age ＜37 weeks by ultrasound, 17 cases with premature rupture of membranes, and 5 cases with prior cesarean section history were excluded, and the remaining 202 cases were included in our study. Based on the methods of IOD, the 202 cases were divided into two groups: DBC group ( n=95) and dinoprostone group ( n=107). The multiparas in DBC group were treated with DBC(Cervical Ripening Balloon; Cook OB/GYN, Spencer, IN, USA) for labor induction. The DBC involved 2 balloons (uterine and vaginal balloons). First, the uterine balloon (red piston, marked with “U”) was inserted into the lower part of the uterine by long oval forceps under direct visualization and 40mL of normal saline solution was injected in. Then the vaginal balloon (green piston, marked with “V”) was pulled out of the cervical orifice slightly, and 40mL of normal saline solution was injected in. When they were correctly situated on either end of the cervix, the fluid amount in both balloons was alternatively increased by 20 mL each time until each balloon reached 80 mL. The external end of the device was taped to the patient’s leg without tension after ensuring that the balloons were positioned correctly. When symptoms of sweating or flustering were unbearable, then 10-20 mL of normal saline was withdrawn from both balloons until the patient could tolerate the DBC. The DBC should be removed immediately upon the occurrence of any of the following events, including spontaneous labour, expulsion, spontaneous ruptured membranes, or unexplained vaginal bleeding. If those events do not happen, the DBC device will be removed after holding for 12h. [14] The multiparas in dinoprostone group were induced with a slow-release vaginal insert containing 10 mg of dinoprostone (prostaglandins PGE2 Propess®, Ferring SAS, Gentilly, France). The slow-release vaginal insert was stored in a freezer at a temperature between -20 0 C and -10 0 C. Dinoprostone should be removed in case of spontaneous exit, labor, being placed in the vagina for over 24h. After the removal or self-expulsion of the IOL agents, patients underwent a vaginal examination and then transferred to the delivery ward for spontaneous labor or augmentation by oxytocin infusion and/or artificial rupture of membranes with a 60-min interval if uterine contractions were not adequate. Epidural analgesia was provided under maternal request after uterine orifice dilation was more than or equal to 1cm. Continuous monitoring of uterine activity and fetal heart rate was performed during active labor. Observation indicators Information including maternal age, maternal body mass index (BMI) before pregnancy and at time of IOL, gravidity, parity, abortion history, vaginal delivery history, indication for IOL, initial Bishop score, labor and perinatal period were collected and recorded in a form specially designed for this trial. To compare the efficacy and safety of DBC and dinoprostone for labor induction, total vaginal delivery rate, rate of vaginal delivery within 24h, rate of uterine hyperstimulation combined with abnormal fetal heart rate and rate of fetal distress were regarded as the primary outcome variables. Secondary outcome variables include indications for cesarean section, insertion to active labor, length of first stage of labor, length of second stage of labor, length of third stage of labor, length of total labor, oxytocin augmentation, artificial rupture of membrane, postpartum hemorrhage, amniotic fluid fecal staining, precipitate labor, episiotomy, perineal laceration, prenatal fever, neuraxial analgesia.Neonatal outcomes include newborn weight, neonatal asphyxia, neonatal intensive care unit (NICU) admission. Cesarean section on maternal request is defined as the cesarean section based solely on maternal request without any maternal or fetal medical indications. Insertion to active labor is defined as the time from placing the DBC or applying dinoprostone to the start of regular contractions. Uterine hyperstimulation is defined as contractions more than 5 in 10 min for more than 20 min or contractions lasting more than 2 min in duration [15] . Fetal distress is defined as the symptoms that endanger the health and life of the fetus in utero due to acute or chronic hypoxia. Precipitate labor is defined as the total length of labor exceeding 3 hours. Failed induction is defined as no active labor within 48 hours of induced labor. Adverse neonatal outcome variables include neonatal asphyxia, neonatal intensive care unit admission. Statistical methods All analyses were conducted using the Statistical Package of Social Sciences software (SPSS Version 26.0 Inc., Chicago, IL, USA). Continuous variables were presented as means ± standard deviation and categorical variables were presented as frequency and percentage (%). Student’s t-test was performed to compare the variables in a Gaussian distribution. The chi-square test or Fisher’s exact test were used to evaluate the categorical variables. The Mann-Whitney test was used to evaluate the difference in a non-Gaussian distribution between two groups. The difference was considered statistically significant when p ＜0.05. Results As shown in Table 1 , baseline characteristics of multiparas with labor induction in DBC group and dinoprostone group were comparatively analyzed. There were no significant differences in maternal age, BMI at delivery, gravidity, parity, abortion history, vaginal delivery history, indication for IOL, initial Bishop score between the two groups ( p > 0.05). Table 1 Baseline characteristics of multiparas between in the DBC and Dinoprostone Characteristics DBC Dinoprostone p value (n = 95) (n = 107) Age (y, \(\stackrel{-}{ X}\pm s\) ) 32.3 ± 4.1 32.2 ± 2.9 0.839 ≥ 35y (n, %) 27, 28.4 23, 21.5 0.255 BMI before pregnancy (kg/m 2 \(,\stackrel{-}{ X}\pm s\) ) 21.3 ± 2.4 21.9 ± 2.7 0.075 BMI at time of IOL (kg/m 2 \(,\stackrel{-}{ X}\pm s\) ) 26.5 ± 3.0 27.1 ± 2.7 0.086 Gravidity(min-max) 2–5 2–9 0.386 Parity(min-max) 1.0 ± 0.1 1.0 ± 0.2 0.497 Abortion history (n, %) None 39(41.1) 52(48.6) 0.282 Once 28(29.5) 33 (30.8) Twice 17(17.9) 12(11.2) Three times 11(11.6) 8(7.5) ≥Foure times 0(0) 2(1.9) Vaginal delivery history (n, %) Once 93, 97.9 103, 96.3 0.495 Twice 2, 2.1 4, 3.7 Indication for IOL (n, %) Social/elective 16, 16.8 26, 24.3 0.259 Delayed gestation 15, 15.8 9, 8.4 Gestational hypertension 7, 7.4 7, 6.5 Gestational diabetes 40, 42.1 52, 48.6 Suspected oligohydramnios 17, 17.9 13, 12.2 Neuraxial labor analgesia (n, %) 53, 55.8 51, 47.7 0.249 Initial Bishop score ( \(\stackrel{-}{ X}\pm s\) ) 4.2 ± 0.6 4.4 ± 0.6 0.080 p < 0.05 was considered signifcant DBC: double balloon catheter BMI: body mass index IOL: induction of labor Student’s t-test, chi-square test and Mann-Whitney test were used Overall, natural delivery rate, cesarean section rate and forceps delivery rate were 89.1% (180/202), 9.9% (20/202) and 1.0% (2/202), respectively. The vaginal delivery (including forceps) rates within 24h, 36h, 48h, ＞48h were 75.8%, 88.4%, 92.6%, 93.7% in DBC group, and 71.0%, 82.2%, 83.2%, 86.9% in dinoprostone group, and there was no statistical differences between in the two groups( p ＜0.05), as shown in Table 2 . Table 2 Comparison of vaginal birth rate within different parturition time between in DBC and Dinoprostone 24h 36h 48h > 48h Delivery mode DBC (n = 95) Dinoprostone (n = 107) DBC (n = 95) Dinoprostone (n = 107) DBC (n = 95) Dinoprostone (n = 107) DBC (n = 95) Dinoprostone (n = 107) Vaginal delivery(n, %) 72, 75.8 76, 71.0 84,88.4 88, 82.2 88, 92.6 89, 83.2 89, 93.7 93, 86.9 Cesarean delivery (n, %) 6, 6.3 8, 7.5 6, 6.3 9, 8.4 6, 6.3 12, 11.2 6, 6.3 14, 13.1 p value 0.679 0.511 0.195 0.108 p < 0.05 was considered signifcant DBC: double balloon catheter Chi-square test was used Further, the indications for cesarean section in DBC group included fetal distress (n = 4), antepartum haemorrhage (n = 1), maternal request cesarean section (n = 1), and those in dinoprostone included fetal distress (n = 11), failed induction(n = 2), cesarean section on maternal request (n = 1). The main maternal outcome variables of DBC group and in dinoprostone group were comparatively analyzed (Table 3 ). The rate of uterine hyperstimulation combined with abnormal FHR was higher in the dinoprostone group than in the DBC group (5.6% vs 0%, p = 0.019), and the rates of amniotic fluid fecal staining and prenatal fever in the dinoprostone group were higher than in the DBC group (19.6% vs 9.5%, p = 0.043 and 19.6% vs 8.4%, p = 0.023). The rates of oxytocin augmentation and artificial rupture of membrane were higher in the DBC group than in the dinoprostone group (77.9% vs 19.6%, p ＜0.001 and 63.2% vs 10.3%, p ＜0.001). Moreover, there were no significant difference in the rates of precipitate delivery, fetal distress, neuraxial analgesia, postpartum hemorrhage, episiotomy, perineal laceration between the two groups ( p ＞0.05). The median time of insertion to active labor in the DBC group was 992.3 m, which was longer than that in the dinoprostone group (753.2m, p ＜0.001), but there were no significant difference in the median time of first stage of labor, second stage of labor, third stage of labor and the total labor between the two groups ( p ＞0.05). Table 3 Maternal outcomes between DBC and Dinoprostone Outcomes DBC Dinoprostone p value (n = 95) (n = 107) Insertion to active labor(m, \(\stackrel{-}{ X}\pm s\) ) 992.3 ± 430.9 753.2 ± 766.8 < 0.001 Length of first stage of labor (m, \(\stackrel{-}{ X}\pm s\) ) 253.3 ± 109.8 283.1 ± 133.8 0.102 Length of second stage of labor (m, \(\stackrel{-}{ \text{X}}\pm \text{s}\) ) 14.7 ± 12.0 15.0 ± 13.2 0.872 Length of third stage of labor (m, \(\stackrel{-}{ X}\pm s\) ) 9.8 ± 7.7 9.0 ± 6.7 0.459 Length of total labor (m, \(\stackrel{-}{ X}\pm s\) ) 277.8 ± 112.5 307.1 ± 138.7 0.121 Neuraxial analgesia (n, %) 53, 55.8 51, 47.7 0.249 Oxytocin augmentation (n, %) 74, 77.9 21,19.6 < 0.001 Artificial rupture of membrane (n, %) 60, 63.2 11,10.3 < 0.001 Postpartum hemorrhage(≥ 500ml) (n, %) 8, 8.4 6, 5.6 0.432 Uterine hyperstimulation with FHR changs (n, %) 0, 0 6, 5.6 0.019 Amniotic fluid fecal staining (n, %) 9, 9.5 21, 19.6 0.043 Prenatal fever (n, %) 8, 8.4 21, 19.6 0.023 Fetal distress (n, %) 4, 4.2 11, 10.3 0.101 Precipitate labour (n, %) 8, 8.4 13, 12.2 0.386 Episiotomy (n, %) 2, 2.1 6, 5.6 0.203 Perineal laceration (n, %) 3, 3.2 3, 2.8 0.882 p < 0.05 was considered signifcant DBC: double balloon catheter Student’s t-test,chi-square test or Fisher’s exact test and Mann-Whitney test were used Table 4 shows the main outcomes of newbabies. Neonatal outcomes were similar in both study groups. The average birth weight in the DBC group and the dinoprostone group was 3399.1 ± 383.7 g and 3480.8 ± 381.0 g ( p = 0.131). There were two babies having an Apgar score of less than 7 at 5 min in the dinoprostone group, but one baby in the DBC group. There were 2 babies staying in neonatal intensive care unit for both groups. Table 4 Neonatal outcomes between DBC and Dinoprostone Outcomes DBC Dinoprostone p value (n = 95) (n = 107) Birthweight (g, \(\stackrel{-}{ X}\pm s\) )) 3399.1 ± 383.7 3480.8 ± 381.0 0.131 Adverse neonatal outcome (n, %) 2, 2.1 2, 1.9 0.904 Mild asphyxia(n, %) 1,1.1 2,1.9 0.632 NICU(n, %) 2,2.1 2,1.9 0.904 p < 0.05 was considered signifcant DBC: double balloon catheter Student’s t-test,chi-square test or Fisher’s exact test were used Discussion Nowadays, double balloon catheter(DBC) and dinoprostone as two useful methods for induction of labor in pregnant women at term have been widely used in clinical practice [ 16 – 18 ] . In our trial, we compared the efficacy and safety of DBC and dinoprostone as labor-inducing agents just in multipara at term. Our findings indicate that DBC and Dinoprostone seem to be equally effective since there were no differences in rate of vaginal delivery within 24 h, total vaginal delivery rate and caesarean section rate under the two different methods. However, DBC seems to have a more higher safety than dinoprostone as it led to lower rates of uterine hyperstimulation combined with abnormal FHR, amniotic fluid fecal staining, renatal fever, and there was a downward trend of fetal distress in DBC group compared with dinoprostone group. The rate of vaginal delivery within 24 h was recommended by members of guidelines development groups in WHO(World Health Organization) and NICE (National Institute for Health and Clinical Excellence) as the most clinically relevant indication to evaluate the effectiveness of labor induction methods. Moreover, vaginal delivery rate and cesarean section rate have also been used as important indicators to evaluate the effectiveness of labor induction methods. Several studies have compared the efficacy of balloon catheters and dinoprostone, and conflicting results were obtained. A Cochrane analysis [ 19 ] found that there may be little or n significant difference in the rate of vaginal delivery within 24 hours ((RR = 1.01, 95% CI 0.82–1.26) and rate of cesarean section (RR = 1.00, 95% CI 0.92–1.09)when using ballon and vaginal PGE2 as labor-inducing agents, which is consistent with the results of another analysis [ 20 ] . Du et al. [ 21 ] reported that the overall vaginal delivery rate in women treated with double balloon catheter was similar with that of dinoprostone (71.6% vs 62.8%; P > 0.05), but more women were vaginally delivered within 24 h in dinoprostone group (52.26% vs37.62%, P = 0.0079). Suffecool et al. [ 22 ] reported that more women were vaginally delivered within 24 h in double-balloon catheter group (87.1% vs 47.4%, P = 0.002) than in dinoprostone group. In our trial, there were no significant differences in rate of total vaginal delivery rate, rate of vaginal delivery within 24 h and rate of cesarean section between DBC group and dinoprostone group, although the time from start of induction to active labor was longer in DBC group than in dinoprostone group, and these results are similar to those reported in the recent meta-analysis mentioned above [ 19 , 20 ] . For a method to induce labor, safety seems to be a more important index than efficacy. As an exogenous PGE2, dinoprostone can not only stimulate cervical remodelling ,but also initiate uterine contractions via stimulating endogenous prostaglandin F2α production or sensitizing the myometrium to the effects of endogenous or exogenous oxytocin [ 18 ] . The most significant adverse event associated with dinoprostone is uterine hyperstimulation. Wing et al. [ 23 ] found that the rate of uterine hyperstimulation combined with FHR accounted for 4.0% in the dinoprostone group, while Rugarn et al. [ 24 ] reported this rate was 1.2%. DBC was used to induce labor by mechanically dilating the cervix and stimulating the release of prostaglandins from the amniotic membrane, chorionic membrane and decidua to ripen the cervix. In the Cochrane analysis [ 19 ] , a balloon catheter probably reduces the rate of uterine hyperstimulation combined with FHR (RR 0.35, 95% CI 0.18–0.67), rate of serious neonatal morbidity or perinatal death (RR 0.48, 95% CI 0.25–0.93) and may slightly reduce the rate of aneonatal intensive care unit (NICU) admission (RR 0.82, 95% CI 0.65–1.04). A recent trial conducted by Grace et al. published in 2021 [ 15 ] reported that the rates of uterine hyperstimulation and foetal distress were lower in DBC group than vaginal prostaglandin group in the first 12 h. However, a multicentre randomized controlled trial in Australian [ 10 ] showed that there were no statistically significant differences in the primary outcome variables and or in the rate of meconium stained liquor (12.6% vs 11.2%, P = 0.647)between DBC group and dinoprostone group (18.6% vs 25.8%; RR = 0.77, 95% CI 0.51–1.02; P = 0.070),but uterine hyperstimulation occurred exclusively in the dinoprostone group (3.0% versus 0%; P = 0.029). Considering that maternal factors and fetal intrauterine conditions would affect neonatal outcomes, Diguisto et al. [ 9 ] observed no difference in the rate of cesarean delivery due to nonreassuring fetal status for prolonged pregnancies between DBC group and dinoprostone group (5.8% vs 5.3%,95% CI − 2.1–3.1%, p = 0.70). Jorge et al. [ 11 ] comparatively studied the safety of dinoprostone and DBC for labor induction in women at term with fetal growth restriction and no differences were observed between the two groups in terms of meconium, intrapartum fever, pH, Apgar scores or the rate of neonatal admissions. In our trial, there were totally14 cesarean section cases in dinoprostone group, including 11 cases due to fetal distress, 2 case due to failed induction, and 1 case on maternal request, accounting for 78.6% ( 11/14 ), 14.3%( 2/14 ), 7.1%( 1/14 ), respectively. Fetal distress caused by overstimulation of the uterus accounted for 54.5%(6/11), with the remaining 45.5%(5/11) caused by umbilical cord and placenta factors in the dinoprostone group. In contrast, there were 6 cases of cesarean section in the DBC group, 4 of which were due to fetal distress caused by umbilical cord factors, and none of the participants experienced uterine overstimulation. It was found that uterine hyperstimulation combined with abnormal FHR occurred exclusively in dinoprostone group, and DBC reduced the risk of amniotic fluid fecal staining. There was a downward trend of fetal distress in the DBC group as compared with the dinoprostone group, although the difference did not reach statistical significance (4.2% vs 10.3%, p = 0.101). As for the risk of infection, a 2015 meta-analysis [ 25 ] showed that Foley catheters for induction of labor was not associated with an increased risk of infection since patients who underwent cervical ripening using a Foley catheter had similar rates of chorioamnionitis (RR 0.96, 95% CI 0.66–1.38), endometritis (RR 1.03, 95% CI 0.66–1.6),pooled maternal infection (RR 0.95, 95% CI 0.81–1.12), and neonatal infection (RR 0.9, 95% CI 0.58–1.39) compared with those using prostaglandins. However, our research found that the rate of prenatal fever in DBC group was lower than that in dinoprostone group. The reason may be that dinoprostone is a PGE2 analogue as well as potent systemic mediator of inflammation and infection, which leads to pyrexia among people during labor. To our knowledge, this study is the first retrospective cohort study comparing the efficacy and safety of double balloon catheter (DBC) and dinoprostone and as labor-inducing agents for multipara at term. However, there are some limitations in this study. First, this study is a retrospective and single center study, the selection of labor induction method may be subjective, and the results are not so objective as the multi-center prospective studies. Second, the sample size of this study is relatively small, the rate of maternal complications such as postpartum hemorrhage, birth canal injury and the rate of neonatal complications such as neonatal asphyxia and NICU admission were very low, so it is uncertain whether there is a difference in the rate of serious complications under the two labor induction methods. Conclusion Double balloon catheter and dinoprostone seem to be equally effective, but double balloon catheter seem to be more safer than dinoprostone for induction of labor for multipara at term. Declarations Acknowledgements We would like to thank all the participants of the trial. We will like to thank the obstetricians and nurses for the diagnosis and treatment of these pregnant women. Authors’ contributions Zhao Y conceived the study, analysed the data, interpreted the results, and revised the manuscript. Yang LJ conceived the study, analysed the data, interpreted the results. Yuan L drafted the manuscript. Peng J collected the data. All authors read and approved the final manuscript. Funding This work was supported by the Foundation from Health and Family Planning Commission of Hubei Province (No: WJ2018h0133; No: WJ2019H297) and Innovative Research Team of Hubei Provincial Science and Technology Department (No:2019CFA033). All of the foundations agreed to fund obstetric researchers for data analysis, English editing and other costs related to the dissemination of the study. Availability of data and materials Access to the qualitative data will be given upon request to the corresponding author after taking any necessary precautions to safeguard participants’ privacy and confidentiality. Conflict of interest No confict of interest declared. Ethics approval and consent to participate The study protocol was approved by the Ethics Committee of Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology ([2019] IEC (XM008)). All included women signed written informed consent for therapeutic procedures and for the publication of those reports. References Martin JA, Hamilton BE, Osterman MJK, Driscoll AK, Drake P. (2018) Births: Final Data for 2017. Natl Vital Stat Rep;67(8):1-50 Vogel JP, Souza JP, Gülmezoglu AM. 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(2019) Double-balloon catheter versus dinoprostone insert for labour induction: a meta-analysis. Arch Gynecol Obstet;299(1):7-12, doi:10.1007/s00404-018-4929-8 Du H, Zhang N, Xiao CY, Sun GQ, Zhao Y. (2020) Effectiveness of Dinoprostone and Cook's Balloon for Labor Induction in Primipara Women at Term. Curr Med Sci;40(5):951-959, doi:10.1007/s11596-020-2274-1 Suffecool K, Rosenn BM, Kam S, Mushi J, Foroutan J, Herrera K. (2014) Labor induction in nulliparous women with an unfavorable cervix: double balloon catheter versus dinoprostone. J Perinat Med;42(2):213-8, doi:10.1515/jpm-2013-0152 Wing DA, Brown R, Plante LA, Miller H, Rugarn O, Powers BL. (2013) Misoprostol vaginal insert and time to vaginal delivery: a randomized controlled trial. Obstet Gynecol;122(2 Pt 1):201-209, doi:10.1097/AOG.0b013e31829a2dd6 Rugarn O, Tipping D, Powers B, Wing DA. (2017) Induction of labour with retrievable prostaglandin vaginal inserts: outcomes following retrieval due to an intrapartum adverse event. BJOG;124(5):796-803, doi:10.1111/1471-0528.14147 McMaster K, Sanchez-Ramos L, Kaunitz AM. (2015) Evaluation of a Transcervical Foley Catheter as a Source of Infection: A Systematic Review and Meta-analysis. Obstet Gynecol;126(3):539-551, doi:10.1097/aog.0000000000001002 Cite Share Download PDF Status: Published Journal Publication published 20 Feb, 2023 Read the published version in Archives of Gynecology and Obstetrics → Version 2 posted Reviewers agreed at journal 27 Sep, 2022 Reviewers invited by journal 13 Sep, 2022 Editor invited by journal 12 Sep, 2022 Editor assigned by journal 09 Sep, 2022 First submitted to journal 07 Sep, 2022 You are reading this latest preprint version Show more versions 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. 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Also discoverable on Platform About Our Team In Review Editorial Policies 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-1936435","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[{"code":1,"date":"2022-08-24 14:59:42","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}}],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":140728366,"identity":"62b8782b-0206-4b2c-b613-7cb617d27a42","order_by":0,"name":"lu yuan","email":"","orcid":"","institution":"Maternal and child Hospital of Hubei Province ,Tongji Medical College,Huazhong University of Science and Technology","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"lu","middleName":"","lastName":"yuan","suffix":""},{"id":140728367,"identity":"1fb377d9-3321-4a2f-b044-513a72fe26cf","order_by":1,"name":"Jing Peng","email":"","orcid":"","institution":"","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Jing","middleName":"","lastName":"Peng","suffix":""},{"id":140728368,"identity":"18af6b95-22b2-48dd-9a18-7bacaaf766f3","order_by":2,"name":"Lijun Yang","email":"","orcid":"","institution":"","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Lijun","middleName":"","lastName":"Yang","suffix":""},{"id":140728369,"identity":"55d221ae-d6bf-40bf-b2ad-c559f8310b47","order_by":3,"name":"Yun Zhao","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA10lEQVRIiWNgGAWjYDACCSBOqJDg4WdmPnDgww9itXw4YyMn2d6WeHBmD5FaGGe2pRkb9JwxPszBRoQO+dnNDx/zsB1O3CCR8+EwAw+DPL/YAfxaGOccMzbm4TmcuF0id8PhAgsGw5mzE/BrYZZIMJPmkTicuHMGUMsMHoYEg9sEtLBJpH+T5jEAOuxGzoPDPGxEaOGRyDGTnJEA9P6ZMwzEaZGQyCk2+HAAHMgGwECWIOwX+RnpGx8k/gNH5eMPH37YyPNLE9CCYStpykfBKBgFo2AUYAcAb4pHMBvlZ74AAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0002-2323-2926","institution":"","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Yun","middleName":"","lastName":"Zhao","suffix":""}],"badges":[],"createdAt":"2022-08-06 16:59:08","currentVersionCode":2,"declarations":"","doi":"10.21203/rs.3.rs-1936435/v2","doiUrl":"https://doi.org/10.21203/rs.3.rs-1936435/v2","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s00404-022-06891-9","type":"published","date":"2023-02-20T19:00:28+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":27206048,"identity":"ac19acc9-f9d7-4405-87e7-4818a9e9dce8","added_by":"auto","created_at":"2022-09-30 18:34:56","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":323379,"visible":true,"origin":"","legend":"\u003cp\u003eFlow Diagram\u003c/p\u003e","description":"","filename":"Fig1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-1936435/v2/c5444cfb25c21ebdd2587997.jpg"},{"id":44720115,"identity":"1d1bff8d-4098-416f-97e5-db4aa653fa3e","added_by":"auto","created_at":"2023-10-16 19:07:45","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":394215,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-1936435/v2/ee808f03-d3ff-4b45-b068-737ba6192aca.pdf"}],"financialInterests":"","formattedTitle":"Efficacy and safety of double balloon catheter and dinoprostone for labor induction in multipara at term","fulltext":[{"header":"Introduction","content":"\u003cp\u003eInduction of labor (IOL) is an obstetrical procedure that has been increasingly used in recent years. The proportion of people experiencing IOL increased by nearly 10% from 2007 to 2017, with IOL rate exceeding 25.5% (1 in 4) in 2017\u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]\u003c/sup\u003e. With the implementation of two-child policy, the rate of labor induction at term has been increased to more than 30% in 2013 in China\u003csup\u003e[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]\u003c/sup\u003e. Following the publication of the ARRIVE trial\u003csup\u003e[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/sup\u003e and the implementation of three-child policy, the IOL rate is expected to rise in the future in China.\u003c/p\u003e \u003cp\u003eFor women with an unfavorable cervix (Bishop score\u0026thinsp;\u0026lt;\u0026thinsp;6)\u003csup\u003e[\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]\u003c/sup\u003e, the additional step of cervical ripening is required during induction of labor. There are mechanical and pharmacologic methods of cervical ripening. Approved by the United States Food and Drug Administration (FDA) in 2013, the Cook Cervical Ripening Balloon (Cook Inc; Bloomington, IN) can lead to cervical ripening by either direct mechanical dilation of the cervix or stimulation of prostaglandin released from the amnion, chorion, and decidua\u003csup\u003e[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]\u003c/sup\u003e. Dinoprostone is chemically identical to endogenous prostaglandin E2 (PGE2), which has been approved by the FDA for cervical ripening and has been widely used in several countries throughout the world. There have been many studies comparatively studying the effectiveness and safety of the two labor induction methods\u003csup\u003e[\u003cspan additionalcitationids=\"CR10 CR11 CR12\" citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/sup\u003e. It is well known that the history of vaginal delivery itself is of vital importance for the success of induction, but the vast majority of studies have focused on primipara or have not fully distinguished between primipara and multipara. However, the optimal method for labor induction for multipara at term with an unfavorable cervix remains unknown.\u003c/p\u003e \u003cp\u003eIn this retrospective cohort study conducted in our birth centre from January 1, 2020, to December 30, 2020, the efficacy and safety of DBC and dinoprostone as labor-inducing agents for multipara were comparatively analyzed.\u003c/p\u003e"},{"header":"Materials And Methods","content":"\u003cp\u003e\u003cstrong\u003eEthical approval and patient consent\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study protocol was approved by the Ethics Committee of Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology ([2019] IEC (XM008)). All included women signed written informed consent for therapeutic procedures and for the publication of those reports.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSelection of patients and study design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe flowchart of the experimental design is shown in \u003cstrong\u003eFigure 1\u003c/strong\u003e. In this retrospective cohort study, a total of multiparas aged 18 to 50 years with gestational ages \u0026ge;37 weeks, who had history of vaginal delivery, singleton gestation, vertex presentation, intact membranes, normal preinduction fetal heart rate tracing, Bishop score \u0026lt;6, fetal weight of less than 4500 grams with a ultrasound or clinical estimated were included. The exclusion criteria were pregnant women aged less than 18 years or older than 50 years, primipara, cesarean section. During the observation period at our birth centre from January 1st, 2020 to December 30th, 2020, a total of 252 multiparas were enrolled in this study. Among them, 4 cases with data exceptions, 18 cases with Bishop scores \u0026ge;6, 6 cases with gestation age ＜37 weeks by ultrasound, 17 cases with premature rupture of membranes, and 5 cases with prior cesarean section history were excluded, and the remaining 202 cases were included in our study. Based on the methods of IOD, the 202 cases were divided into two groups: DBC group ( n=95) and dinoprostone group ( n=107).\u003c/p\u003e\n\u003cp\u003eThe multiparas in DBC group were treated with DBC(Cervical Ripening Balloon; Cook OB/GYN, Spencer, IN, USA) for labor induction. The DBC involved 2 balloons (uterine and vaginal balloons). First, the uterine balloon (red piston, marked with \u0026ldquo;U\u0026rdquo;) was inserted into the lower part of the uterine by long oval forceps under direct visualization and 40mL of normal saline solution was injected in. Then the vaginal balloon (green piston, marked with \u0026ldquo;V\u0026rdquo;) was pulled out of the cervical orifice slightly, and 40mL of normal saline solution was injected in. When they were correctly situated on either end of the cervix, the fluid amount in both balloons was alternatively increased by 20 mL each time until each balloon reached 80 mL. The external end of the device was taped to the patient\u0026rsquo;s leg without tension after ensuring that the balloons were positioned correctly. When symptoms of sweating or flustering were unbearable, then 10-20 mL of normal saline was withdrawn from both balloons until the patient could tolerate the DBC. The DBC should be removed immediately upon the occurrence of any of the following events, including spontaneous labour, expulsion, spontaneous ruptured membranes, or unexplained vaginal bleeding. If those events do not happen, the DBC device will be removed after holding for 12h. \u003cstrong\u003e\u003csup\u003e[14]\u003c/sup\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe multiparas in\u0026nbsp;dinoprostone group\u0026nbsp;were induced with a slow-release vaginal insert containing 10 mg of dinoprostone (prostaglandins PGE2 Propess\u0026reg;, Ferring SAS, Gentilly, France). The slow-release vaginal insert was stored in a freezer at a temperature between -20\u003csup\u003e0\u003c/sup\u003eC and -10\u003csup\u003e0\u003c/sup\u003eC. Dinoprostone should be removed in case of spontaneous exit, labor, being placed in the vagina for over 24h.\u003c/p\u003e\n\u003cp\u003eAfter the removal or self-expulsion of the IOL agents, patients underwent a vaginal examination and then transferred to the delivery ward for spontaneous labor or augmentation by oxytocin infusion and/or artificial rupture of membranes with a 60-min interval if uterine contractions were not adequate. Epidural analgesia was provided under maternal request after uterine orifice dilation was more than or equal to 1cm. Continuous monitoring of uterine activity and fetal heart rate was performed during active labor.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObservation indicators\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInformation including maternal age, maternal body mass index (BMI) before pregnancy and at time of IOL, gravidity, parity, abortion history, vaginal delivery history, indication for IOL, initial Bishop score, labor and perinatal period were collected and recorded in a form specially designed for this trial. To compare the efficacy and safety of DBC and dinoprostone for labor induction, total vaginal delivery rate, rate of vaginal delivery within 24h, rate of uterine hyperstimulation combined with abnormal fetal heart rate and rate of fetal distress were regarded as the primary outcome variables. Secondary outcome variables include indications for cesarean section, insertion to active labor, length of first stage of labor, length of second stage of labor, length of third stage of labor, length of total labor, oxytocin augmentation, artificial rupture of membrane, postpartum hemorrhage, amniotic fluid fecal staining, precipitate labor, episiotomy, perineal laceration, prenatal fever, neuraxial analgesia.Neonatal outcomes include newborn weight, neonatal asphyxia, neonatal intensive care unit (NICU) admission. Cesarean section on maternal request is defined as the cesarean section based solely on maternal request without any maternal or fetal medical indications. Insertion to active labor is defined as the time from placing the DBC or applying dinoprostone to the start of regular contractions. Uterine hyperstimulation is defined as contractions more than 5 in 10 min for more than 20 min or contractions lasting more than 2 min in duration\u003csup\u003e[15]\u003c/sup\u003e. Fetal distress is defined as the symptoms that endanger the health and life of the fetus in utero due to acute or chronic hypoxia. Precipitate labor is defined as the total length of labor exceeding 3 hours. Failed induction is defined as no active labor within 48 hours of induced labor. Adverse neonatal outcome variables include neonatal asphyxia, neonatal intensive care unit admission.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical methods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll analyses were conducted using the Statistical Package of Social Sciences software (SPSS Version 26.0 Inc., Chicago, IL, USA). Continuous variables were presented as means \u0026plusmn; standard deviation and categorical variables were presented as frequency and percentage (%). Student\u0026rsquo;s t-test was performed to compare the variables in a Gaussian distribution. The chi-square test or Fisher\u0026rsquo;s exact test were used to evaluate the categorical variables. The Mann-Whitney test was used to evaluate the difference in a non-Gaussian distribution between two groups. The difference was considered statistically significant when \u003cem\u003ep\u003c/em\u003e＜0.05.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eAs shown in Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e, baseline characteristics of multiparas with labor induction in DBC group and dinoprostone group were comparatively analyzed. There were no significant differences in maternal age, BMI at delivery, gravidity, parity, abortion history, vaginal delivery history, indication for IOL, initial Bishop score between the two groups (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05).\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab1\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eBaseline characteristics of multiparas between in the DBC and Dinoprostone\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eCharacteristics\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eDBC\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eDinoprostone\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e\u003cem\u003ep\u003c/em\u003e 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\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;95)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;107)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eAge (y,\u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(\\stackrel{-}{ X}\\pm s\\)\u003c/span\u003e\u003c/span\u003e)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e32.3\u0026thinsp;\u0026plusmn;\u0026thinsp;4.1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e32.2\u0026thinsp;\u0026plusmn;\u0026thinsp;2.9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.839\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026ge;\u0026thinsp;35y (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e27, 28.4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e23, 21.5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.255\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eBMI before pregnancy (kg/m\u003csup\u003e2\u003c/sup\u003e\u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(,\\stackrel{-}{ X}\\pm s\\)\u003c/span\u003e\u003c/span\u003e)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e21.3\u0026thinsp;\u0026plusmn;\u0026thinsp;2.4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e21.9\u0026thinsp;\u0026plusmn;\u0026thinsp;2.7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.075\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eBMI at time of IOL\u003c/p\u003e\n\u003cp\u003e(kg/m\u003csup\u003e2\u003c/sup\u003e\u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(,\\stackrel{-}{ X}\\pm s\\)\u003c/span\u003e\u003c/span\u003e)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e26.5\u0026thinsp;\u0026plusmn;\u0026thinsp;3.0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e27.1\u0026thinsp;\u0026plusmn;\u0026thinsp;2.7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.086\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eGravidity(min-max)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u0026ndash;5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u0026ndash;9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.386\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eParity(min-max)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1.0\u0026thinsp;\u0026plusmn;\u0026thinsp;0.1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1.0\u0026thinsp;\u0026plusmn;\u0026thinsp;0.2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.497\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eAbortion history (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNone\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e39(41.1)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e52(48.6)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.282\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOnce\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e28(29.5)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e33 (30.8)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eTwice\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e17(17.9)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e12(11.2)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eThree times\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11(11.6)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e8(7.5)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026ge;Foure times\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0(0)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2(1.9)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"1\" align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eVaginal delivery history (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOnce\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e93, 97.9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e103, 96.3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.495\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eTwice\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2, 2.1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4, 3.7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eIndication for IOL (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSocial/elective\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e16, 16.8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e26, 24.3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.259\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDelayed gestation\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e15, 15.8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e9, 8.4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eGestational hypertension\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e7, 7.4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e7, 6.5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eGestational diabetes\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e40, 42.1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e52, 48.6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSuspected oligohydramnios\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e17, 17.9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e13, 12.2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNeuraxial labor analgesia (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e53, 55.8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e51, 47.7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.249\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eInitial Bishop score (\u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(\\stackrel{-}{ X}\\pm s\\)\u003c/span\u003e\u003c/span\u003e)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4.2\u0026thinsp;\u0026plusmn;\u0026thinsp;0.6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4.4\u0026thinsp;\u0026plusmn;\u0026thinsp;0.6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.080\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003ctfoot\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\"\u003e\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered signifcant\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\"\u003eDBC: double balloon catheter BMI: body mass index IOL: induction of labor\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\"\u003eStudent\u0026rsquo;s t-test, chi-square test and Mann-Whitney test were used\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tfoot\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/div\u003e\n\u003cp\u003eOverall, natural delivery rate, cesarean section rate and forceps delivery rate were 89.1% (180/202), 9.9% (20/202) and 1.0% (2/202), respectively. The vaginal delivery (including forceps) rates within 24h, 36h, 48h, ＞48h were 75.8%, 88.4%, 92.6%, 93.7% in DBC group, and 71.0%, 82.2%, 83.2%, 86.9% in dinoprostone group, and there was no statistical differences between in the two groups(\u003cem\u003ep\u003c/em\u003e＜0.05), as shown in Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab2\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eComparison of vaginal birth rate within different parturition time between in DBC and Dinoprostone\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n\u003cth colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003e24h\u003c/p\u003e\n\u003c/th\u003e\n\u003cth colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003e36h\u003c/p\u003e\n\u003c/th\u003e\n\u003cth colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003e48h\u003c/p\u003e\n\u003c/th\u003e\n\u003cth colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003e\u0026gt;\u0026thinsp;48h\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\u003eDelivery mode\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDBC\u003c/p\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;95)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDinoprostone\u003c/p\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;107)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDBC\u003c/p\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;95)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDinoprostone\u003c/p\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;107)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDBC\u003c/p\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;95)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDinoprostone\u003c/p\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;107)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDBC\u003c/p\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;95)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDinoprostone\u003c/p\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;107)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eVaginal delivery(n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e72, 75.8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e76, 71.0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e84,88.4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e88, 82.2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e88, 92.6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e89, 83.2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e89, 93.7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e93, 86.9\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCesarean delivery (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6, 6.3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e8, 7.5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6, 6.3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e9, 8.4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6, 6.3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e12, 11.2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6, 6.3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e14, 13.1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cem\u003ep\u003c/em\u003e value\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003e0.679\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003e0.511\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003e0.195\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"2\" align=\"left\"\u003e\n\u003cp\u003e0.108\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003ctfoot\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"9\"\u003e\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered signifcant\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"9\"\u003eDBC: double balloon catheter Chi-square test was used\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tfoot\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/div\u003e\n\u003cp\u003eFurther, the indications for cesarean section in DBC group included fetal distress (n\u0026thinsp;=\u0026thinsp;4), antepartum haemorrhage (n\u0026thinsp;=\u0026thinsp;1), maternal request cesarean section (n\u0026thinsp;=\u0026thinsp;1), and those in dinoprostone included fetal distress (n\u0026thinsp;=\u0026thinsp;11), failed induction(n\u0026thinsp;=\u0026thinsp;2), cesarean section on maternal request (n\u0026thinsp;=\u0026thinsp;1).\u003c/p\u003e\n\u003cp\u003eThe main maternal outcome variables of DBC group and in dinoprostone group were comparatively analyzed (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e). The rate of uterine hyperstimulation combined with abnormal FHR was higher in the dinoprostone group than in the DBC group (5.6% vs 0%, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.019), and the rates of amniotic fluid fecal staining and prenatal fever in the dinoprostone group were higher than in the DBC group (19.6% vs 9.5%, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.043 and 19.6% vs 8.4%, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.023). The rates of oxytocin augmentation and artificial rupture of membrane were higher in the DBC group than in the dinoprostone group (77.9% vs 19.6%, \u003cem\u003ep\u003c/em\u003e＜0.001 and 63.2% vs 10.3%, \u003cem\u003ep\u003c/em\u003e＜0.001). Moreover, there were no significant difference in the rates of precipitate delivery, fetal distress, neuraxial analgesia, postpartum hemorrhage, episiotomy, perineal laceration between the two groups (\u003cem\u003ep\u003c/em\u003e＞0.05). The median time of insertion to active labor in the DBC group was 992.3 m, which was longer than that in the dinoprostone group (753.2m, \u003cem\u003ep\u003c/em\u003e＜0.001), but there were no significant difference in the median time of first stage of labor, second stage of labor, third stage of labor and the total labor between the two groups (\u003cem\u003ep\u003c/em\u003e＞0.05).\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab3\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eMaternal outcomes between DBC and Dinoprostone\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eOutcomes\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eDBC\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eDinoprostone\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e\u003cem\u003ep\u003c/em\u003e 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\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;95)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;107)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eInsertion to active labor(m,\u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(\\stackrel{-}{ X}\\pm s\\)\u003c/span\u003e\u003c/span\u003e)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e992.3\u0026thinsp;\u0026plusmn;\u0026thinsp;430.9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e753.2\u0026thinsp;\u0026plusmn;\u0026thinsp;766.8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\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\u003eLength of first stage of labor (m,\u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(\\stackrel{-}{ X}\\pm s\\)\u003c/span\u003e\u003c/span\u003e )\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e253.3\u0026thinsp;\u0026plusmn;\u0026thinsp;109.8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e283.1\u0026thinsp;\u0026plusmn;\u0026thinsp;133.8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.102\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eLength of second stage of labor (m,\u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(\\stackrel{-}{ \\text{X}}\\pm \\text{s}\\)\u003c/span\u003e\u003c/span\u003e )\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e14.7\u0026thinsp;\u0026plusmn;\u0026thinsp;12.0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e15.0\u0026thinsp;\u0026plusmn;\u0026thinsp;13.2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.872\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eLength of third stage of labor (m,\u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(\\stackrel{-}{ X}\\pm s\\)\u003c/span\u003e\u003c/span\u003e )\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e9.8\u0026thinsp;\u0026plusmn;\u0026thinsp;7.7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e9.0\u0026thinsp;\u0026plusmn;\u0026thinsp;6.7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.459\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eLength of total labor (m,\u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(\\stackrel{-}{ X}\\pm s\\)\u003c/span\u003e\u003c/span\u003e)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e277.8\u0026thinsp;\u0026plusmn;\u0026thinsp;112.5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e307.1\u0026thinsp;\u0026plusmn;\u0026thinsp;138.7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.121\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNeuraxial analgesia (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e53, 55.8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e51, 47.7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.249\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOxytocin augmentation (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e74, 77.9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e21,19.6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\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\u003eArtificial rupture of membrane (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e60, 63.2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11,10.3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\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\u003ePostpartum hemorrhage(\u0026ge;\u0026thinsp;500ml) (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e8, 8.4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6, 5.6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.432\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eUterine hyperstimulation with FHR changs (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0, 0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6, 5.6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\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\u003eAmniotic fluid fecal staining (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e9, 9.5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e21, 19.6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.043\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePrenatal fever (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e8, 8.4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e21, 19.6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.023\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eFetal distress (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4, 4.2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11, 10.3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.101\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePrecipitate labour (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e8, 8.4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e13, 12.2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.386\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eEpisiotomy (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2, 2.1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6, 5.6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.203\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePerineal laceration (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3, 3.2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3, 2.8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.882\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003ctfoot\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\"\u003e\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered signifcant\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\"\u003eDBC: double balloon catheter Student\u0026rsquo;s t-test,chi-square test or Fisher\u0026rsquo;s exact test and Mann-Whitney test were used\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tfoot\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/div\u003e\n\u003cp\u003eTable\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e shows the main outcomes of newbabies. Neonatal outcomes were similar in both study groups. The average birth weight in the DBC group and the dinoprostone group was 3399.1\u0026thinsp;\u0026plusmn;\u0026thinsp;383.7 g and 3480.8\u0026thinsp;\u0026plusmn;\u0026thinsp;381.0 g (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.131). There were two babies having an Apgar score of less than 7 at 5 min in the dinoprostone group, but one baby in the DBC group. There were 2 babies staying in neonatal intensive care unit for both groups.\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab4\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eNeonatal outcomes between DBC and Dinoprostone\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eOutcomes\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eDBC\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eDinoprostone\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003e\u003cem\u003ep\u003c/em\u003e 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\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;95)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;107)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eBirthweight (g,\u003cspan class=\"InlineEquation\"\u003e\u003cspan class=\"mathinline\"\u003e\\(\\stackrel{-}{ X}\\pm s\\)\u003c/span\u003e\u003c/span\u003e))\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3399.1\u0026thinsp;\u0026plusmn;\u0026thinsp;383.7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3480.8\u0026thinsp;\u0026plusmn;\u0026thinsp;381.0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.131\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eAdverse neonatal outcome (n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2, 2.1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2, 1.9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.904\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMild asphyxia(n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1,1.1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2,1.9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.632\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNICU(n, %)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2,2.1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2,1.9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.904\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003ctfoot\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\"\u003e\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered signifcant\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\"\u003eDBC: double balloon catheter Student\u0026rsquo;s t-test,chi-square test or Fisher\u0026rsquo;s exact test were used\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tfoot\u003e\n\u003c/table\u003e\n\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eNowadays, double balloon catheter(DBC) and dinoprostone as two useful methods for induction of labor in pregnant women at term have been widely used in clinical practice\u003csup\u003e[\u003cspan additionalcitationids=\"CR17\" citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/sup\u003e. In our trial, we compared the efficacy and safety of DBC and dinoprostone as labor-inducing agents just in multipara at term. Our findings indicate that DBC and Dinoprostone seem to be equally effective since there were no differences in rate of vaginal delivery within 24 h, total vaginal delivery rate and caesarean section rate under the two different methods. However, DBC seems to have a more higher safety than dinoprostone as it led to lower rates of uterine hyperstimulation combined with abnormal FHR, amniotic fluid fecal staining, renatal fever, and there was a downward trend of fetal distress in DBC group compared with dinoprostone group.\u003c/p\u003e \u003cp\u003e The rate of vaginal delivery within 24 h was recommended by members of guidelines development groups in WHO(World Health Organization) and NICE (National Institute for Health and Clinical Excellence) as the most clinically relevant indication to evaluate the effectiveness of labor induction methods. Moreover, vaginal delivery rate and cesarean section rate have also been used as important indicators to evaluate the effectiveness of labor induction methods. Several studies have compared the efficacy of balloon catheters and dinoprostone, and conflicting results were obtained. A Cochrane analysis\u003csup\u003e[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]\u003c/sup\u003e found that there may be little or n significant difference in the rate of vaginal delivery within 24 hours ((RR\u0026thinsp;=\u0026thinsp;1.01, 95% CI 0.82\u0026ndash;1.26) and rate of cesarean section (RR\u0026thinsp;=\u0026thinsp;1.00, 95% CI 0.92\u0026ndash;1.09)when using ballon and vaginal PGE2 as labor-inducing agents, which is consistent with the results of another analysis\u003csup\u003e[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]\u003c/sup\u003e. Du et al.\u003csup\u003e[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]\u003c/sup\u003e reported that the overall vaginal delivery rate in women treated with double balloon catheter was similar with that of dinoprostone (71.6% vs 62.8%; P\u0026thinsp;\u0026gt;\u0026thinsp;0.05), but more women were vaginally delivered within 24 h in dinoprostone group (52.26% vs37.62%, P\u0026thinsp;=\u0026thinsp;0.0079). Suffecool et al.\u003csup\u003e[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]\u003c/sup\u003e reported that more women were vaginally delivered within 24 h in double-balloon catheter group (87.1% vs 47.4%, P\u0026thinsp;=\u0026thinsp;0.002) than in dinoprostone group. In our trial, there were no significant differences in rate of total vaginal delivery rate, rate of vaginal delivery within 24 h and rate of cesarean section between DBC group and dinoprostone group, although the time from start of induction to active labor was longer in DBC group than in dinoprostone group, and these results are similar to those reported in the recent meta-analysis mentioned above\u003csup\u003e[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eFor a method to induce labor, safety seems to be a more important index than efficacy. As an exogenous PGE2, dinoprostone can not only stimulate cervical remodelling ,but also initiate uterine contractions via stimulating endogenous prostaglandin F2α production or sensitizing the myometrium to the effects of endogenous or exogenous oxytocin\u003csup\u003e[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/sup\u003e. The most significant adverse event associated with dinoprostone is uterine hyperstimulation. Wing et al.\u003csup\u003e[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]\u003c/sup\u003efound that the rate of uterine hyperstimulation combined with FHR accounted for 4.0% in the dinoprostone group, while Rugarn et al.\u003csup\u003e[\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]\u003c/sup\u003e reported this rate was 1.2%. DBC was used to induce labor by mechanically dilating the cervix and stimulating the release of prostaglandins from the amniotic membrane, chorionic membrane and decidua to ripen the cervix. In the Cochrane analysis\u003csup\u003e[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]\u003c/sup\u003e, a balloon catheter probably reduces the rate of uterine hyperstimulation combined with FHR (RR 0.35, 95% CI 0.18\u0026ndash;0.67), rate of serious neonatal morbidity or perinatal death (RR 0.48, 95% CI 0.25\u0026ndash;0.93) and may slightly reduce the rate of aneonatal intensive care unit (NICU) admission (RR 0.82, 95% CI 0.65\u0026ndash;1.04). A recent trial conducted by Grace et al. published in 2021\u003csup\u003e[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/sup\u003e reported that the rates of uterine hyperstimulation and foetal distress were lower in DBC group than vaginal prostaglandin group in the first 12 h. However, a multicentre randomized controlled trial in Australian\u003csup\u003e[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]\u003c/sup\u003e showed that there were no statistically significant differences in the primary outcome variables and or in the rate of meconium stained liquor (12.6% vs 11.2%, P\u0026thinsp;=\u0026thinsp;0.647)between DBC group and dinoprostone group (18.6% vs 25.8%; RR\u0026thinsp;=\u0026thinsp;0.77, 95% CI 0.51\u0026ndash;1.02; P\u0026thinsp;=\u0026thinsp;0.070),but uterine hyperstimulation occurred exclusively in the dinoprostone group (3.0% versus 0%; P\u0026thinsp;=\u0026thinsp;0.029). Considering that maternal factors and fetal intrauterine conditions would affect neonatal outcomes, Diguisto et al.\u003csup\u003e[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/sup\u003e observed no difference in the rate of cesarean delivery due to nonreassuring fetal status for prolonged pregnancies between DBC group and dinoprostone group (5.8% vs 5.3%,95% CI\u0026thinsp;\u0026minus;\u0026thinsp;2.1\u0026ndash;3.1%, p\u0026thinsp;=\u0026thinsp;0.70). Jorge \u003cem\u003eet al.\u003c/em\u003e\u003csup\u003e[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]\u003c/sup\u003ecomparatively studied the safety of dinoprostone and DBC for labor induction in women at term with fetal growth restriction and no differences were observed between the two groups in terms of meconium, intrapartum fever, pH, Apgar scores or the rate of neonatal admissions. In our trial, there were totally14 cesarean section cases in dinoprostone group, including 11 cases due to fetal distress, 2 case due to failed induction, and 1 case on maternal request, accounting for 78.6% ( 11/14 ), 14.3%( 2/14 ), 7.1%( 1/14 ), respectively. Fetal distress caused by overstimulation of the uterus accounted for 54.5%(6/11), with the remaining 45.5%(5/11) caused by umbilical cord and placenta factors in the dinoprostone group. In contrast, there were 6 cases of cesarean section in the DBC group, 4 of which were due to fetal distress caused by umbilical cord factors, and none of the participants experienced uterine overstimulation. It was found that uterine hyperstimulation combined with abnormal FHR occurred exclusively in dinoprostone group, and DBC reduced the risk of amniotic fluid fecal staining. There was a downward trend of fetal distress in the DBC group as compared with the dinoprostone group, although the difference did not reach statistical significance (4.2% vs 10.3%, p\u0026thinsp;=\u0026thinsp;0.101).\u003c/p\u003e \u003cp\u003eAs for the risk of infection, a 2015 meta-analysis\u003csup\u003e[\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]\u003c/sup\u003e showed that Foley catheters for induction of labor was not associated with an increased risk of infection since patients who underwent cervical ripening using a Foley catheter had similar rates of chorioamnionitis (RR 0.96, 95% CI 0.66\u0026ndash;1.38), endometritis (RR 1.03, 95% CI 0.66\u0026ndash;1.6),pooled maternal infection (RR 0.95, 95% CI 0.81\u0026ndash;1.12), and neonatal infection (RR 0.9, 95% CI 0.58\u0026ndash;1.39) compared with those using prostaglandins. However, our research found that the rate of prenatal fever in DBC group was lower than that in dinoprostone group. The reason may be that dinoprostone is a PGE2 analogue as well as potent systemic mediator of inflammation and infection, which leads to pyrexia among people during labor.\u003c/p\u003e \u003cp\u003eTo our knowledge, this study is the first retrospective cohort study comparing the efficacy and safety of double balloon catheter (DBC) and dinoprostone and as labor-inducing agents for multipara at term. However, there are some limitations in this study. First, this study is a retrospective and single center study, the selection of labor induction method may be subjective, and the results are not so objective as the multi-center prospective studies. Second, the sample size of this study is relatively small, the rate of maternal complications such as postpartum hemorrhage, birth canal injury and the rate of neonatal complications such as neonatal asphyxia and NICU admission were very low, so it is uncertain whether there is a difference in the rate of serious complications under the two labor induction methods.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eDouble balloon catheter and dinoprostone seem to be equally effective, but double balloon catheter seem to be more safer than dinoprostone for induction of labor for multipara at term.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u0026nbsp;\u003c/strong\u003eWe would like to thank all the participants of the trial. We will like to thank the obstetricians and nurses for the diagnosis and treatment of these pregnant women.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u0026nbsp;\u003c/strong\u003eZhao Y conceived the study, analysed the data, interpreted the results, and revised the manuscript. Yang LJ conceived the study, analysed the data, interpreted the results. Yuan L drafted the manuscript. Peng J collected the data. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u0026nbsp;\u003c/strong\u003eThis work was supported by the Foundation from Health and Family Planning Commission of Hubei Province (No: WJ2018h0133; No: WJ2019H297) and Innovative Research Team of Hubei Provincial Science and Technology Department (No:2019CFA033). All of the foundations agreed to fund obstetric researchers for data analysis, English editing and other costs related to the dissemination of the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u0026nbsp;\u003c/strong\u003eAccess to the qualitative data will be given upon request to the corresponding author after taking any necessary precautions to safeguard participants\u0026rsquo; privacy and confidentiality.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of interest\u0026nbsp;\u003c/strong\u003eNo confict of interest declared.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e The study protocol was approved by the Ethics Committee of Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology ([2019] IEC (XM008)). All included women signed written informed consent for therapeutic procedures and for the publication of those reports.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eMartin JA, Hamilton BE, Osterman MJK, Driscoll AK, Drake P. (2018) Births: Final Data for 2017. Natl Vital Stat Rep;67(8):1-50\u003c/li\u003e\n\u003cli\u003eVogel JP, Souza JP, G\u0026uuml;lmezoglu AM. (2013) Patterns and Outcomes of Induction of Labour in Africa and Asia: a secondary analysis of the WHO Global Survey on Maternal and Neonatal Health. PLoS One;8(6):e65612, doi:10.1371/journal.pone.0065612\u003c/li\u003e\n\u003cli\u003eGrobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, et al. (2018) Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med;379(6):513-523, doi:10.1056/NEJMoa1800566\u003c/li\u003e\n\u003cli\u003eACOG Practice Bulletin No. 107: Induction of labor. 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Drugs;78(15):1615-1624, doi:10.1007/s40265-018-0995-2\u003c/li\u003e\n\u003cli\u003ede Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, et al. (2019) Mechanical methods for induction of labour. Cochrane Database Syst Rev;10(10):Cd001233, doi:10.1002/14651858.CD001233.pub3\u003c/li\u003e\n\u003cli\u003eLiu YR, Pu CX, Wang XY, Wang XY. (2019) Double-balloon catheter versus dinoprostone insert for labour induction: a meta-analysis. Arch Gynecol Obstet;299(1):7-12, doi:10.1007/s00404-018-4929-8\u003c/li\u003e\n\u003cli\u003eDu H, Zhang N, Xiao CY, Sun GQ, Zhao Y. (2020) Effectiveness of Dinoprostone and Cook\u0026apos;s Balloon for Labor Induction in Primipara Women at Term. Curr Med Sci;40(5):951-959, doi:10.1007/s11596-020-2274-1\u003c/li\u003e\n\u003cli\u003eSuffecool K, Rosenn BM, Kam S, Mushi J, Foroutan J, Herrera K. (2014) Labor induction in nulliparous women with an unfavorable cervix: double balloon catheter versus dinoprostone. J Perinat Med;42(2):213-8, doi:10.1515/jpm-2013-0152\u003c/li\u003e\n\u003cli\u003eWing DA, Brown R, Plante LA, Miller H, Rugarn O, Powers BL. (2013) Misoprostol vaginal insert and time to vaginal delivery: a randomized controlled trial. Obstet Gynecol;122(2 Pt 1):201-209, doi:10.1097/AOG.0b013e31829a2dd6\u003c/li\u003e\n\u003cli\u003eRugarn O, Tipping D, Powers B, Wing DA. (2017) Induction of labour with retrievable prostaglandin vaginal inserts: outcomes following retrieval due to an intrapartum adverse event. BJOG;124(5):796-803, doi:10.1111/1471-0528.14147\u003c/li\u003e\n\u003cli\u003eMcMaster K, Sanchez-Ramos L, Kaunitz AM. (2015) Evaluation of a Transcervical Foley Catheter as a Source of Infection: A Systematic Review and Meta-analysis. Obstet Gynecol;126(3):539-551, doi:10.1097/aog.0000000000001002\u003c/li\u003e\n\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":"archives-of-gynecology-and-obstetrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"arch","sideBox":"Learn more about [Archives of Gynecology and Obstetrics](https://www.springer.com/journal/404)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/arch/default.aspx","title":"Archives of Gynecology and Obstetrics","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Multipara, double balloon catheter, dinoprostone, induction of labor, vaginal delivery","lastPublishedDoi":"10.21203/rs.3.rs-1936435/v2","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-1936435/v2","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003ePurpose\u003c/h2\u003e \u003cp\u003eThe aim of this study was to comparatively assess the efficacy and safety of double balloon catheter (DBC) and dinoprostone as labor-inducing agents just for multipara at term.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eA retrospective cohort study was conducted among multipara at term with a Bishop score\u0026thinsp;\u0026lt;\u0026thinsp;6 who needed planned labor induction from January 1, 2020, to December 30, 2020 in Maternal and Child Health Hospital of Hubei province, Tongji Medical College, Huazhong University of Science and Technology. They were divided into DBC group and dinoprostone group respectively. Baseline maternal data, maternal and neonatal outcomes were recorded for statistical analysis. Total vaginal delivery rate, rate of vaginal delivery within 24 h, rate of uterine hyperstimulation combined with abnormal fetal heart rate(FHR) were regarded as the primary outcome variables. The diffrerence between groups was considered statistically significant when \u003cem\u003ep\u003c/em\u003e value\u0026thinsp;\u0026lt;\u0026thinsp;0.05.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eA total of 202 multipara was included for analysis (95 women in DBC group vs 107 women in dinoprostone group\u003cb\u003e).\u003c/b\u003e There were no significant differences in total vaginal delivery rate and rate of vaginal delivery within 24 h between groups. Uterine hyperstimulation combined with abnormal FHR occurred exclusively in dinoprostone group.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eDBC and dinoprostone seem to be equally effective, and DBC seems to be safer than dinoprostone as it causes lower rate of uterine hyperstimulation combined with abnormal FHR.\u003c/p\u003e","manuscriptTitle":"Efficacy and safety of double balloon catheter and dinoprostone for labor induction in multipara at term","msid":"","msnumber":"","nonDraftVersions":[{"code":2,"date":"2022-09-30 18:21:01","doi":"10.21203/rs.3.rs-1936435/v2","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2022-09-27T17:52:04+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2022-09-13T08:51:18+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"Archives of Gynecology and Obstetrics","date":"2022-09-12T19:55:10+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2022-09-09T10:44:59+00:00","index":"","fulltext":""},{"type":"submitted","content":"Archives of Gynecology and Obstetrics","date":"2022-09-07T12:02:13+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"archives-of-gynecology-and-obstetrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"arch","sideBox":"Learn more about [Archives of Gynecology and Obstetrics](https://www.springer.com/journal/404)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/arch/default.aspx","title":"Archives of Gynecology and Obstetrics","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"4abc7e69-adae-4d1a-87c1-c39fa0ea222c","owner":[],"postedDate":"September 30th, 2022","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2023-10-16T19:04:19+00:00","versionOfRecord":{"articleIdentity":"rs-1936435","link":"https://doi.org/10.1007/s00404-022-06891-9","journal":{"identity":"archives-of-gynecology-and-obstetrics","isVorOnly":false,"title":"Archives of Gynecology and Obstetrics"},"publishedOn":"2023-02-20 19:00:28","publishedOnDateReadable":"February 20th, 2023"},"versionCreatedAt":"2022-09-30 18:21:01","video":"","vorDoi":"10.1007/s00404-022-06891-9","vorDoiUrl":"https://doi.org/10.1007/s00404-022-06891-9","workflowStages":[]},"version":"v2","identity":"rs-1936435","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-1936435","identity":"rs-1936435","version":["v2"]},"buildId":"GqpaHPwrfC8PjnIFayRh5","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}