Impact of dinoprostone versus cook cervical ripening balloon on induction in pregnancies complicated by small-for-gestational-age fetuses at term.

OBJECTIVE: To explore the complications and pregnancy outcomes of vaginal dinoprostone vs. Cook's double balloon for the induction of labor among pregnancies complicated by small-for-gestational-age (SGA) at term. METHODS: This retrospective study included consecutive singleton pregnancies complicated by SGA treated at Fujian Maternity and Child Health Hospital between January 2017 and December 2021. The patients were divided into the Cook's double balloon and dinoprostone groups according to the induction method they received. The primary outcome was vaginal delivery. RESULTS: This study included 318 women [165 (aged 30.25 ± 4.72 years) and 153 (aged 28.80 ± 3.91 years) in the dinoprostone and Cook's balloon groups]. The dinoprostone group had a higher vaginal delivery rate than the Cook's balloon group (83.6% vs. 71.9%, p = .012). The cervical ripening duration (9.73 ± 4.82 vs. 17.50 ± 8.77 h, p < .001) and induction to delivery duration (22.11 ± 8.13 vs. 30.27 ± 12.28, p < .001) were significantly shorter in the dinoprostone group compared with the Cook's balloon group. Less women needed oxytocin infusion in the dinoprostone group compared with that in the Cook's balloon group (32.7% vs. 86.3%, p < .001). Dinoprostone was independently associated with vaginal delivery (HR = 1.756, 95%CI: 1.286-2.399, p = .000). The rates of uterine tachysystole and spontaneous rupture of the fetal membrane were significantly higher in the dinoprostone group than that in the Cook's balloon group (10.3% vs. 0.7%, p < .001; 7.3% vs. 1.3%, p = .012). There were no differences in maternal complications and neonatal outcomes between the two groups. CONCLUSION: In pregnant woman with pregnancies complicated by SGA, cervical ripening using dinoprostone were more likely to achieve vaginal delivery than those with Cook's balloon, and with a favorable complication profile.

Double Balloon Combined with Oxytocin in Labor Induction: Analysis of Multivariate Factors Affecting the Efficacy of Cervical Ripening.

Objective: Labor induction during the late trimester of pregnancy is a common option of terminating pregnancy by inducing uterine contractions through medication or cervical mechanical dilation. However, there are few researches on the factors influencing the effectiveness of cervical ripening balloon combined with oxytocin in inducing labor. To explore factors affecting the efficacy of cervical ripening double balloon combined with oxytocin in labor induction. Methods: Using a convenient sampling method, this study retrospectively collected the clinical data of 230 pregnant women who underwent cervical ripening double balloon combined with oxytocin for labor induction in our hospital from September 2021 to August 2022. The included subjects were divided into a vaginal delivery group (n = 180) and a cesarean section group (n = 50) based on the delivery mode for comparing relevant indicators between the two groups. Results: The presence of acute chorioamnionitis (OR = 1.456, 95% CI: 1.257-2.112), fetal distress (OR = 1.371, 95% CI: 1.331-2.633), and the placement of cervical ripening balloon catheter for >12h (OR = 1.563, 95% CI: 1.231-3.263) were risk factors for successful application of cervical ripening double balloon combined with oxytocin for labor induction in pregnant women; while multi-gravidity (OR = 0.736, 95% CI: 0.455-0.875) was a protective factor. In addition, evaluation of the predictive value revealed that acute chorioamnionitis, fetal distress, the placement of cervical ripening balloon catheter for >12h, and gravidity all had certain predictive value for the failure of cervical ripening double balloon combined with oxytocin for labor induction, with the highest predictive value found through joint predictive (AUC: 0.931, 95% CI: 0.714-0.811). Conclusion: Cervical ripening double balloon combined with oxytocin for labor induction may have a high success rate in multigravida. Acute chorioamnionitis, fetal distress, and prolonged placement of the balloon may have a negative impact on the success rate of cervical ripening double balloon combined with oxytocin for labor induction.

Cervical ripening balloon compared with vaginal dinoprostone for cervical ripening in obese women at term: A prospective cohort study.

OBJECTIVE: To evaluate vaginal delivery in obese women who underwent cervical ripening at term using a dinoprostone vaginal insert or a cervical ripening balloon (CRB), and to assess maternal and neonatal morbidity according to the method. METHODS: A prospective cohort study including obese women with a live singleton fetus in cephalic presentation who required cervical ripening at term (≥37 weeks) for maternal and/or fetal disease using a dinoprostone vaginal insert or a CRB. The primary outcome was vaginal delivery. Secondary outcomes were a favorable cervix (Bishop score >6) after 24 h, the time from device insertion to delivery, and composite maternal and neonatal morbidity. RESULTS: In total, 135 consecutive women were analyzed (107 CRB, 79.3%; 28 dinoprostone vaginal insert, 20.7%). Vaginal delivery (86 [80.4%] after CRB vs 19 [67.9%] after dinoprostone vaginal insert; P = 0.248), favorable cervix within 24 h after device placement (52 [48.6%] vs 17 [60.7%]; P = 0.264), and maternal morbidity (12 [11.2%] vs 4 [14.3%]; P = 0.646) were similar between the groups. The time from device insertion to delivery also did not differ between the groups. Neonatal morbidity was significantly higher after the dinoprostone vaginal insert (11 [39.3%] vs 20 [18.7%]; P = 0.030). Cervical ripening using the dinoprostone vaginal insert, compared with the CRB, was significantly associated with neonatal morbidity (adjusted odds ratio 4.00, 95% confidence interval 1.34-12.5), but not with maternal morbidity (adjusted odds ratio 1.23, 95% confidence interval 0.30-4.38). CONCLUSIONS: Vaginal delivery, a favorable cervix after 24 h, the time from device insertion to delivery, and maternal morbidity did not significantly differ between the CRB and the dinoprostone vaginal insert for cervical ripening in obese women at term. Nevertheless, neonatal morbidity was significantly associated with the dinoprostone vaginal insert, compared with the CRB, among obese women who required cervical ripening at term.

Time from insertion to expulsion of cervical ripening balloon in preterm versus term inductions of labor.

OBJECTIVE: Preterm induction of labor can be necessary for maternal and fetal wellbeing. Duration of cervical ripening balloon (CRB) use has been studied in only term inductions. Our study investigated duration of time in hours for CRB expulsion and vaginal delivery in preterm inductions of labor. METHODS: This was a single-institution retrospective cohort study of preterm (< 37 weeks) and term (≥ 37 weeks) inductions with CRB between 2010 and 2021. Cesarean deliveries were excluded. Primary outcome was insertion to expulsion time of CRB. Secondary outcomes included induction to delivery time, cervical dilation after expulsion, misoprostol, and Pitocin use. Institutional review board (IRB) approval was obtained prior to the study. RESULTS: Ninety-eight patients with vaginal delivery after preterm CRB use were identified and matched 1:1 on baseline characteristics (p > 0.05) to term patients with vaginal delivery after CRB use. Mean insertion to expulsion time was significantly shorter for term than preterm inductions (mean 7.2 ± 3.09 h versus 8.5 ± 3.38 h; p < 0.01). Mean induction to delivery time was significantly shorter for term than preterm inductions (18.4 ± 7.6 h versus 22.5 ± 9.01 h; p < 0.01). Increased use of misoprostol, Pitocin, and second CRB were noted among the preterm cohort. Among term patients, more CRB placement at start of induction and greater cervical dilation post-balloon were found in comparison to preterm patients. CONCLUSION: Among patients undergoing preterm induction, longer insertion to expulsion time of CRB, longer induction to delivery time, and increased interventions should be expected. Different standards for labor management should be considered for achieving vaginal delivery in preterm inductions.

Induction of Labour with a Double Balloon Catheter - Comparison of Effectiveness of Six Versus Twelve Hours Insertion Time: a Prospective Case Control Study.

Introduction: Induction of labour is a common obstetric procedure to initiate or augment contractions when labour is delayed or uncertain. The double balloon catheter is a safe and effective mechanical method for cervical ripening during induction of labour. This study evaluates the effectiveness of reducing double balloon catheter insertion time from 12 to 6 hours. Methods: 248 women undergoing induction with a double balloon catheter at term were divided into two groups: catheter placed for 12 hours at 8 pm in the first half of 2021 (P12) and catheter placed for 6 hours at 7 am in the second half of 2021 (P6). T-tests, chi-squared tests, and Wilcoxon signed rank test were used for statistical analysis. Primary and secondary endpoints included induction to delivery interval, prostaglandin to delivery interval, mode of delivery, and maternal and neonatal outcomes. Results: The P6 group had a significantly reduced induction to delivery interval of 558 min (P6: 1348 min, P12: 1906 min, p < 0.01, 95% CI: 376-710) within demographically comparable groups. Multiparous women also showed a significant reduction in prostaglandin to delivery interval of 260 min (P6: 590 min, P12: 850 min, p = 0.038, 95% CI: 9-299). There were no significant differences in mode of delivery, maternal blood loss, or neonatal outcome. Conclusion: Reducing double balloon catheter placement time from 12 to 6 hours resulted in almost 9 hours less induction to delivery interval without adverse effects on maternal and neonatal outcome.

Developing a nomogram for estimating the risk of needing to perform a caesarean section after induction of labour in pregnancies using a COOK® Cervical Ripening Balloon.

BACKGROUND: Using a COOK® Cervical Ripening Balloon (CCRB) for cervical maturity has become a common clinical practice for the induction of labour (IOL). OBJECTIVE: To develop and validate a predictive instrument that could estimate the risk of a caesarean after IOL in term pregnancies with CCRB treatment. METHODS: The medical records of 415 pregnant women requiring IOL from January 2018 to October 2022 were retrospectively reviewed and randomly selected for training (290) and validation (125) sets in a 7:3 ratio. A model for predicting the risk of a caesarean was virtualised by a nomogram using logistic regression analysis. RESULTS: After completing the multivariate analysis, parity (odds ratio [OR] = 0.226; p= 0.017), modified Bishop score at induction (OR =0.688; p= 0.005) and the artificial rupture of membranes (OR = 0.436; p= 0.010) were identified as the predictors for implementing a caesarean delivery after IOL. The decision curve analysis showed that the model achieved a net benefit across all threshold probabilities. CONCLUSION: We successfully constructed a nomogram for caesarean delivery after IOL in pregnancies with CCRB treatment using factors including parity, modified Bishop score at induction and the artificial rupture of membrane.

Application of intrauterine balloons in cervical ripening.

INTRODUCTION: At present, the double balloon represented by the COOK Cervix Ripening Balloon and the single balloon represented by the Foley catheter are the commonly used intrauterine balloons. The application of intrauterine balloons in cervical ripening has evolved over 100 years. Although intrauterine balloons have been widely used in cervical ripening, the effect of labor induction in clinical practice does not satisfy all clinicians, especially patients with poor cervical maturity. AREAS COVERED: The research in this review is about intrauterine balloons and cervical ripening. EXPERT OPINION: This article reviews the historical evolution and different application methods of intrauterine balloons in cervical ripening, such as application range, placement method and placement duration of intrauterine balloons, volume and temperature of the solution fillings, and whether to apply traction to the catheter. We aim to better understand the principle of intrauterine balloons in cervical ripening and make this method more effective.

Induction of Labor in Women with Previous Cesarean Section and Unfavorable Cervix: A Retrospective Cohort Study.

Background: The efficacy and safety of a cervical ripening balloon (CRB) in women with a previous cesarean section (CS) and unfavorable Bishop score are still controversial. Methods: A retrospective cohort study was performed across six tertiary hospitals from 2015 to 2019. Women with one previous transverse CS, singleton cephalic term pregnancy and BS < 6 were included if submitted to labor induction with a CRB. The main outcome was the rate of vaginal birth after cesarean (VBAC) after CRB ripening. Secondary outcomes were abnormal composite fetal and maternal outcomes. Results: Of the 265 women included, 57.3% had successful vaginal birth. Augmentation improved vaginal delivery (32.2% vs. 21.2%). Intrapartum analgesia was associated with an increased VBAC rate (58.6% vs. 34.5%). Maternal BMI ≥30 and age ≥40 years increased emergency CS rate (11.8% vs. 28.3% and 7.2 vs. 15.9%). Composite adverse maternal outcome occurred in 4.8% of CRB group women and increased to 17.6% when associated with oxytocin. Uterine rupture occurred in one case (0.4%) in the CRB-oxytocin group. Poorer fetal outcome occurred after emergency CS, if compared to successful VBAC (12.4% vs. 3.3%). Conclusions: In women with a previous CS and unfavorable Bishop score, induction of labor with a CRB can be considered safe and effective.

Predictors of efficacy for cervical ripening among the Bishop score criteria in nulliparous women at term.

OBJECTIVE: To determine predictors of efficacy for cervical ripening among the Bishop score criteria in nulliparous women at term. METHOD: Prospective observational study of nulliparous women with singleton term fetuses in vertex presentation, intact membranes, and an unfavorable cervix (Bishop score < 6) who underwent cervical ripening with a cervical-ripening balloon (CRB; n = 47) or dinoprostone vaginal insert (PG; n = 28). The authors analyzed Bishop score criteria (dilatation, effacement, fetal station, consistency, position) before and after device removal. Primary outcome was favorable cervix (Bishop score ≥ 6) after device removal. Secondary outcomes were vaginal delivery, modification of Bishop score criteria, and perinatal morbidity. RESULTS: Rates of favorable cervix after cervical ripening were similar between groups (66.7% with CRB vs. 59.3% with PG; P = 0.526). Vaginal delivery (76.6% vs. 78.6%; P = 0.843) and perinatal morbidity did not differ between groups. CRB appeared to be more effective than PG in increasing consistency (+0.7 ± 0.2 vs. +0.3 ± 0.2; P = 0.001) and dilatation of the cervix (+1.3 ± 0.3 vs. +0.9 ± 0.3; P = 0.005). No Bishop score criterion was found as a significant predictor for vaginal delivery. CONCLUSION: CRB seems to be more effective than PG in increasing the consistency and dilatation of the cervix. Efficacy of CRB and PG for vaginal delivery was similar.

Conventional versus modified application of COOK Cervical Ripening Balloon for induction of labor at term: a randomized controlled trial.

BACKGROUND: This study aims to evaluate the efficacy and safety of the modified application of COOK Cervical Ripening Balloon (CCRB) for induction of labor (IOL) at term in primipara. METHODS: A total of 227 singleton full-term pregnancies with indications of IOL were enrolled and randomly divided into the control and study groups in our hospital from January 2021 to December 2021. In the control group, a conventional method was used. Both the uterine and vaginal balloons were filled to 80 mL and removed after 12 h. In the study group, a modified method was used. The uterine and vaginal balloons were filled to 120 mL and 40 mL respectively. Light traction was given to help CCRB to be discharged after 12 h placement. Oxytocin was administered in both groups after CCRB was discharged before labor starting. The improved Bishop scores, duration of labor, and spontaneous delivery rate were evaluated in the two groups. RESULTS: The improved Bishop scores in the study group were 3.06 ± 0.97 at 12 h placement of CCRB and 4.37 ± 0.87 when CCRB was discharged, which were significantly higher compared to the control group (2.52 ± 0.79, p < 0.05). Duration of the first stage of labor and the full labor in the study group were significantly shorter than those in the control group ((6.17 ± 2.85) h vs. (7.27 ± 2.90) h, p = 0.010; (7.07 ± 3.18) h vs. (8.09 ± 3.11) h, p = 0.028). No difference in spontaneous delivery rate between the two groups was observed. But the delivery rate within 24 h between the two groups was significantly different (79.79% vs. 55.91%, p < 0.05). For the cases with initial Bishop scores ≤ 3, the improved score was significantly increased, the first stage of labor and the full labor were significantly shorter in the study group than those in the control group (p < 0.05). Those results were not observed in cases with initial Bishop scores of 4-6. CONCLUSIONS: The modified application of CCRB could benefit cervical ripening, shorten the duration of labor, especially for cases with poor cervical maturity, and improve the delivery rate within 24 h. TRIAL REGISTRATION: Retrospectively registered: ChiCTR2200058270. Registered 04/04/2022.

Vaginal Dinoprostone Insert versus Cervical Ripening Balloon for Term Induction of Labor in Obese Nulliparas-A Randomized Controlled Trial.

Data regarding the preferred induction method in women with obesity is scarce. The current study was aimed at comparing pharmacological and mechanical induction in this population. This prospective randomized controlled trial was conducted between 2016−2020, in nulliparas with a pre-pregnancy body mass index >30. Inclusion criteria were singleton-term pregnancies, bishop score < 5, and indication for induction. Patients were randomized to induction by a cervical ripening balloon (CRB) or a 10 mg vaginal dinoprostone insert. The primary outcome was delivery rate within 24 h. Secondary outcomes included time to delivery, cesarean section rate, maternal and neonatal outcomes, satisfaction, and anxiety. The study population comprised of 83 women in the CRB group and 81 in the dinoprostone group. There was a significant difference in delivery rates within 24 h and time to delivery between the dinoprostone and CRB groups (45% vs. 71%, p = 0.017 and 49.3 ± 6.8 h vs. 23.5 ± 5.9 h, p = 0.003, respectively). There were no differences in cesarean delivery rates or maternal and neonatal outcomes, though CRB induction was associated with a significantly lower rate of tachysystole. Induction with CRB was accompanied by higher satisfaction and lower anxiety. In summary, CRB induction is associated with shorter time to delivery, higher satisfaction, and lower anxiety compared to PGE2 in women with obesity, without compromising maternal or neonatal outcomes.

Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO).

Background: The aim of this study is to demonstrate that a double balloon catheter combined with oxytocin decreases time between induction of labor and delivery (TID) as compared to a vaginal dinoprostone insert in cases of premature rupture of membranes at term. Methods: This is a prospective, randomized, controlled trial including patient undergoing labor induction for PROM at term with an unfavorable cervix in Clermont-Ferrand university hospital. We compared the double balloon catheter over a period of 12 h with adjunction of oxytocin 6 h after catheter insertion versus dinoprostone vaginal insert. After device ablation, cervical ripening continued only with oxytocin. The main outcome was TID. Secondary outcomes concerned delivery mode, as well as maternal and fetal outcome, and were adjusted for parity. Results: 40 patients per group were randomized. Each group had similar baseline characteristics. The study failed to demonstrate reduced TID (16.2 versus 20.2 h, ES = 0.16 (−0.27 to 0.60), p = 0.12) in the catheter group versus dinoprostone except in nulliparous women (17.0 versus 26.5 h, ES = 0.62 (0.10 to 1.14), p = 0.006). The rate of vaginal delivery <24 h significantly increased with combined induction (88.5% versus 66.6%, p = 0.03). No statistical difference was observed concerning caesarean rate (12.5% versus 17.5%, p > 0.05), chorioamnionitis (0% versus 2.5%, p = 1), postpartum endometritis, or maternal or neonatal outcomes. Procedure-related pain and tolerance to devices were found to be similar for the two methods. Interpretation: The double balloon catheter combined with oxytocin is an alternative for cervical ripening in case of PROM at term, and may reduce TID in nulliparous women.

Cook Cervical Ripening Balloon for placenta accreta spectrum disorders with placenta previa: a novel approach to uterus preserving.

PURPOSE: To evaluate the efficacy of intrauterine inflated Cook Cervical Ripening Balloon (ICRB) in postpartum hemorrhage (PPH) management and fertility preserving for placenta accreta spectrum disorders with placenta previa (previa PAS). METHODS: At a tertiary referral center, 74 patients suffering with previa PAS were entered into this retrospective cohort study from January, 2016 to December, 2020, and were confirmed intraoperatively that abnormal invasive placenta reaches the cervical internal ostium and the upper part of the cervical canal. In control group (n = 39), the combination of infrarenal abdominal aorta balloon occlusion (IAABO) and longitudinal parallel compression suture to lower uterine segment were performed. In study group (n = 35), in addition to the aforementioned surgical techniques, ICRB was implemented at the cervical internal ostium and the outside of the cervix simultaneously. RESULTS: Use of ICRB significantly reduced the rate of peripartum hysterectomy (2.9% vs 30.4%, p = 0.001), and associated with a reduction in surgical time and duration of IAABO (mean 172.7 min vs 206.6 min, p = 0.017; median 30 min vs 40 min, p < 0.001). Use of ICRB significantly reduced the estimated amount of blood loss (median 2500 ml vs 4000 ml, p < 0.001), amounts of packed red blood cells and fresh-frozen plasma transfusion (median 6 U vs 13.5 U, p < 0.001; median 450 ml vs 1200 ml, p < 0.001), postoperative hospital stay and the incidence of oligomenorrhea postoperatively (median 5 days vs 6 days, p = 0.009; 13.8% vs 61.1% p = 0.001). No significant difference was observed between both the groups regarding the use of cryo and PLT, injury of urinary system, relaparotomy, admission to the ICU, postpartum hematocele in uterine cavity, and postoperative complications (including incidence rate of DVT, incidence rate of femoral thrombosis, puerperal morbidity, intrauterine infection, surgical site infection, and deep tissue infection). CONCLUSION: ICRB was a simple, effective procedure for PPH management and fertility preserving in some previa PAS cases in which abnormal invasive placenta reaches the cervical internal ostium and the upper part of the cervical canal, in tandem with IAABO and compression suture.

Comparison of two management options for labor induction following unsuccessful prostaglandin E2 ripening.

OBJECTIVE: We sought to compare the likelihood of a vaginal delivery (VD) using oxytocin, with and without a cervical ripening balloon, in nulliparous women who did not respond to initial ripening with prostaglandin E2 (PGE2). METHODS: We a performed a retrospective cohort study of nulliparous women with a singleton pregnancy at term who underwent cervical ripening with vaginal PGE2 between October 2015 and March 2019. Patients who did not respond to PGE2 ripening (bishop score (BS) of 6 or less with cervical dilation less than 3 cm) were stratified into two groups based on management: sequential ripening with a cervical ripening balloon in addition to oxytocin versus oxytocin alone. Patients who had PGE2 for less than 6 h, a BS greater than 6 after ripening, rupture of membranes or missing data were excluded. The primary outcome was VD. Secondary outcomes included VD within 24 h of induction, time from induction to delivery, rates of chorioamnionitis and postpartum hemorrhage, presence of meconium, neonatal birthweight, NICU admission, 5 min apgar < 5, and umbilical cord pH < 7. Statistical analysis included Chi-squared, Fisher's exact and Mann-Whitney U tests, as well as logistic regression. Odds ratios (ORs) were calculated and adjusted for significant confounders using backwards-stepwise logistic regression. For time to delivery, a Cox proportional hazard regression was used to determine the hazard ratio (HR) and adjusted HR. RESULTS: 840 patients underwent cervical ripening with PGE2 during the study period. After the exclusion criteria were applied, 272 cases comprised the study cohort. Of those, 123 (45%) continued labor induction with a cervical ripening balloon and oxytocin and 149 (55%) continued labor induction with oxytocin alone. Baseline characteristics such as age, BMI, ethnicity, gestational age at induction and number of women undergoing elective induction were similar between both groups. There was no statistically significant difference in the likelihood of VD (oxytocin and cervical ripening balloon: 62.6% vs. oxytocin alone: 50.3%; a OR 1.61, p = .07) or rate of secondary outcomes between the two groups. Patients in the oxytocin alone group had a higher BS after PGE2 ripening, although both were very low (3 vs. 2, p < .0001).". Additionally, there were significantly more patients undergoing full PGE2 ripening for 12 h in the cervical ripening balloon and oxytocin group compared to oxytocin alone (65.9% vs. 49.7%, p = .02). CONCLUSION: Our data did not show a difference in VD rate in nulliparous women unresponsive to PGE2 ripening who underwent continued induction with oxytocin and cervical ripening balloon compared to oxytocin alone. Larger studies investigating the utility of sequential ripening and determining the optimal induction method following unsuccessful ripening are needed.

Optimizing cervical ripening in women presenting with decreased fetal movements.

OBJECTIVE: To determine the optimal method for cervical ripening in women presenting with decreased fetal movements at term. We hypothesized that women who undergo induction of labor for decreased fetal movements represent a higher risk group, and will benefit from mechanical intervention with cervical ripening balloon rather than with pharmacological prostaglandin E2 vaginal insert. STUDY DESIGN: Retrospective cohort study from January 2014 and January 2019. We recommended induction of labor to every woman ≥39 weeks' gestation with complaints of persistent decreased fetal movements. We excluded women with major fetal anomalies, Bishop score of ≥6 on admission, and cases with contraindications to prostaglandins. Women were allocated into one of two groups based on the cervical ripening agent used. In group 1 we introduced the prostaglandin E2 vaginal insert (10 mg dinoprostone in a timed-release formulation). In group 2 we placed the mechanical cervical ripening balloon. The primary outcome of the study, analyzed separately to nulliparous and multiparous women, was the rate of cesarean delivery in each of the groups. RESULTS: During the 5-years study, 294 women were included in the final analysis, of which 201 were in the prostaglandin E2 vaginal insert group and 93 were in the cervical ripening balloon group. The rate of cesarean delivery was comparable between the groups (nulliparous: 20.8%, 16/77 versus 21.3%, 10/47. multiparous: 16.9%, 21/124 versus 7%, 3/46, respectively). Other maternal and neonatal secondary outcomes, including the induction-to-delivery time (nulliparous: 32.5 ± 25.3 h versus 26.5 ± 12.2 h. multiparous: 24.6 ± 17.2 h versus 21.25 ± 12.3 h, respectively), were also not different between the two induction methods used. A longer induction-to-delivery time was observed in nulliparous women who had repeat prostaglandin E2 vaginal insert compared with the cervical ripening balloon group (74.6 ± 27.3 h versus 26.5 ± 12.2 h, p < .01). CONCLUSION: Both pharmacological and mechanical methods can safely and efficiently be used for cervical ripening in women presenting with decreased fetal movements at term. With repeat prostaglandin E2 use, nulliparous women may experience a prolong labor compared with the cervical ripening balloon group, but maternal or fetal safety are not compromised.

Double Foley catheter for labor induction: An alternative method.

OBJECTIVE: To introduce a new handmade device, the double Foley catheter (DFC), and compare it with the Foley catheter (FC) and Cook cervical ripening balloon for its effectiveness in labor induction. METHODS: This prospective randomized controlled trial included 222 patients with unfavorable cervices. The patients were randomly allocated to the DFC, FC, and Cook cervical ripening balloon groups (n = 74 patients per group). The outcomes were evaluated using SPSS v. 23. RESULTS: Bishop scores successfully increased with all three methods (P = 0.000 for all groups), and the rates of vaginal delivery within 24 and 48 h were similar (P = 0.101 and P = 0.390, respectively). The pain scores of the DFC and Cook cervical ripening balloon groups were similar, but were lower than those of the FC group (P = 0.011). The overall maternal satisfaction scores of the DFC and Cook cervical ripening balloon groups were not significantly different but were higher than those of the FC group (P = 0.014). CONCLUSION: The maternal safety and success rate of labor induction were comparable between groups. However, the FC group had a higher pain score during catheter insertion and a lower maternal satisfaction rate. Moreover, considering the high cost of the Cook cervical ripening balloon, the DFC has an advantage, especially in low-resource countries.

Developing and validating the Caesarean risk assessment nomogram and comparing the effect of cervical ripening balloon, evening primrose oil and misoprostol on childbirth outcomes in term pregnancies: A study protocol.

AIM: To develop and validate the nomogram for risk estimation of Caesarean delivery and to compare the effect of cervical ripening balloon, evening primrose oil (EPO) and misoprostol on Bishop Score and duration of the first stage of labour. DESIGN: The first phase is a prospective study, and the second phase is a randomized controlled trial. METHODS: In the first phase, the nomogram will be developed and validated over 300 participants, and in the second phase, the 90 participants will be allocated to three groups: vaginal 25mcg misoprostol, vaginal 4000mg EPO and double-balloon catheter, through block randomization method. The Bishop score will be evaluated every 4 hr, and if required the same dose will be repeated. Maximum waiting time for balloon is 12 hr if not effective, the catheter will be removed, and other interventions will be done according to guidelines. DISCUSSION: The nomogram will help informed decision-making for women undergoing an induction with an unfavourable cervix and introducing effective low-complication methods of labour induction can improve the pregnancy outcomes.

Prostaglandin insert dinoprostone versus trans-cervical balloon catheter for outpatient labour induction: a randomised controlled trial of feasibility (PROBIT-F).

BACKGROUND: The aim was to assess the feasibility of conducting a randomised controlled trial (RCT) of induction of labour comparing use of two methods in the outpatient setting. METHODS: An open-label feasibility RCT was conducted in two UK maternity units from October 2017 to March 2019. Women aged ≥ 16 years, undergoing induction of labour (IOL) at term, with intact membranes and deemed suitable for outpatient IOL according to local guidelines were considered eligible. They were randomised to cervical ripening balloon catheter (CRB) or vaginal dinoprostone (Propess). The participants completed a questionnaire and a sub-group underwent detailed interview. Service use and cost data were collected via the Adult Service Use Schedule (AD-SUS). Women who declined to participate were requested to complete a decliners' questionnaire. RESULTS: During the study period, 274 eligible women were identified. Two hundred thirty (83.9%) were approached for participation of whom 84/230 (36.5%) agreed and 146 did not. Of these, 38 were randomised to Propess (n = 20) and CRB (n = 18). Decliner data were collected for 93 women. The reasons for declining were declining IOL (n = 22), preference for inpatient IOL (n = 22) and preference for a specific method, Propess (n = 19). The intended sample size of 120 was not reached due to restrictive criteria for suitability for outpatient IOL, participant preference for Propess and shortage of research staff.The intervention as randomised was received by 29/38 (76%) women. Spontaneous vaginal delivery was observed in 9/20 (45%) women in the dinoprostone group and 11/18 (61%) women in the CRB group. Severe maternal adverse events were recorded in one woman in each group. All babies were born with good condition and all except one (37/38, 97.4%) remained with the mother after delivery. No deaths were recorded. - 21% of women in the dinoprostone group were re-admitted prior to diagnosis of active labour compared to 12% in the CRB group. CONCLUSIONS: A third of the approached eligible women agreed for randomisation. An RCT is not feasible in the current service context. Modifications to the eligibility criteria for outpatient IOL, better information provision and round the clock availability of research staff would be needed to reach sufficient numbers. TRIAL REGISTRATION: NCT03199820. Registered on June 27, 2017.

Declined use of cervical ripening balloon did not reduce the incidence of umbilical cord prolapse in Japan.

AIM: To clarify whether the incidence of umbilical cord prolapse (UCP) at delivery is related to the cervical ripening balloon (CRB). METHODS: A postal questionnaire study was conducted in 2018 in institutions providing maternity services across Japan. Questions on the number of deliveries, labor inductions, used CRB and cases of UCP in 2017 were included. Because a similar questionnaire survey was conducted in 2012, the incidence of UCP and frequency of the use of CRB were compared. RESULTS: A total of 1354 answers were assessed (57% of all delivery institutions). The total number of deliveries was 490 279. Of these, 78% were transvaginal; 74 cases of UCP were reported (0.015%), while 13 cases were reported from obstetric facilities never using CRB (0.008%). The incidence of UCP (odds ratio [95% confidence interval]) was 0.036% in the intracervical type (4.3 [1.6-11.3]), 0.091% in the disk-type (11.0 [4.2-29.0]) and 0.067% in the ball-type (8.1 [2.8-22.8]). Frequencies of the use of CRB were 7.3% and 6.6% in the 2012 and 2018 surveys, respectively. The use of the intracervical type increased from 2.8% in the 2012 survey to 3.5% in the 2018 survey, while that of the disk-type and ball-type declined. However, the incidence of UCP was not different between the two surveys regardless of the use of cervical ripening balloons (0.014% vs 0.015% with CRB, 0.005% vs 0.008% without CRB). CONCLUSION: Although the frequency of CRB use significantly declined, the incidence of UCP did not significantly reduce in the last 5 years.

Double-balloon catheter compared with single-balloon catheter for induction of labor with a scarred uterus.

BACKGROUND: In obstetrics, labor induction is a common procedure. It has been proved that both single balloon catheters (Foley's catheter) and double balloon catheters (Cook cervical ripening balloon) are effective and relatively safe in cervical ripening and labor induction. This research aimed to compare the efficacy of single and double balloon catheter in the induction of labor with scarred uterus. METHODS: 120 pregnant women who had prior cesarean delivery participated in this research and were randomized into single-balloon catheter group (n = 60) and double-balloon catheter group (n = 60). The cervical ripening effect, security, and influence to the process of childbirth were analyzed in each group. RESULTS: The validity of cervical ripening in single balloon group was better than double balloon group. Double balloon catheters increased the time between insertion and expulsion of the catheter and decreased spontaneous catheter expulsion rate. All the neonatal outcomes in these two groups were comparable. CONCLUSION: Based on our data, the two different catheters both have their pros and cons in the labor induction of pregnant women with scarred uterus. The appropriate catheter used based on specific circumstance will improve the quality of labor induction.