Cervical ripening in prolonged pregnancies by silicone double balloon catheter versus vaginal dinoprostone slow release system: The MAGPOP randomised controlled trial.

BACKGROUND: Prolonged pregnancies are a frequent indication for induction of labour. When the cervix is unfavourable, cervical ripening before oxytocin administration is recommended to increase the likelihood of vaginal delivery, but no particular method is currently recommended for cervical ripening of prolonged pregnancies. This trial evaluates whether the use of mechanical cervical ripening with a silicone double balloon catheter for induction of labour in prolonged pregnancies reduces the cesarean section rate for nonreassuring fetal status compared with pharmacological cervical ripening by a vaginal pessary for the slow release of dinoprostone (prostaglandin E2). METHODS AND FINDINGS: This is a multicentre, superiority, open-label, parallel-group, randomised controlled trial conducted in 15 French maternity units. Women with singleton pregnancies, a vertex presentation, ≥41+0 and ≤42+0 weeks' gestation, a Bishop score <6, intact membranes, and no history of cesarean delivery for whom induction of labour was decided were randomised to either mechanical cervical ripening with a Cook Cervical Ripening Balloon or pharmacological cervical ripening by a Propess vaginal pessary serving as a prostaglandin E2 slow-release system. The primary outcome was the rate of cesarean for nonreassuring fetal status, with an independent endpoint adjudication committee determining whether the fetal heart rate was nonreassuring. Secondary outcomes included delivery (time from cervical ripening to delivery, number of patients requiring analgesics), maternal and neonatal outcomes. Between January 2017 and December 2018, 1,220 women were randomised in a 1:1 ratio, 610 allocated to a silicone double balloon catheter, and 610 to the Propess vaginal pessary for the slow release of dinoprostone. The mean age of women was 31 years old, and 80% of them were of white ethnicity. The cesarean rates for nonreassuring fetal status were 5.8% (35/607) in the mechanical ripening group and 5.3% (32/609) in the pharmacological ripening group (proportion difference: 0.5%; 95% confidence interval (CI) -2.1% to 3.1%, p = 0.70). Time from cervical ripening to delivery was shorter in the pharmacological ripening group (23 hours versus 32 hours, median difference 6.5 95% CI 5.0 to 7.9, p < 0.001), and fewer women required analgesics in the mechanical ripening group (27.5% versus 35.4%, difference in proportion -7.9%, 95% CI -13.2% to -2.7%, p = 0.003). There were no statistically significant differences between the 2 groups for other delivery, maternal, and neonatal outcomes. A limitation was a low observed rate of cesarean section. CONCLUSIONS: In this study, we observed no difference in the rates of cesarean deliveries for nonreassuring fetal status between mechanical ripening with a silicone double balloon catheter and pharmacological cervical ripening with a pessary for the slow release of dinoprostone. TRIAL REGISTRATION: ClinicalTrials.gov NCT02907060.

Balloon catheter vs oxytocin alone for induction of labor in women with a previous cesarean section: A randomized controlled trial.

INTRODUCTION: The aim of this study was to compare the efficacy and maternal-neonatal morbidity between balloon catheter and oxytocin for induction of labor in women with a previous cesarean section and an unfavorable cervix. MATERIAL AND METHODS: This open-label randomized controlled trial took place in seven French hospitals. Inclusion criteria were medical indication for labor induction in pregnant women, ≥37 weeks, with lower segment cesarean section, Bishop score ≤4, no pre-labor rupture of membranes, singleton fetus in cephalic presentation. Women were allocated randomly to induction with a 50-mL balloon catheter for 12 hours or a low-dose oxytocin infusion. Primary outcome was the rate of vaginal birth. Secondary outcomes were maternal and neonatal complications. RESULTS: The study enrolled 204 women from 26 December 2010 to 31 December 2013: 101 were allocated to receive balloon catheter and 103 to oxytocin. Vaginal birth rate was 50% (n = 51) in the balloon catheter group vs 37% (n = 38) in the oxytocin group (P = 0.050). Maternal and neonatal morbidity did not differ between balloon catheter and oxytocin groups: two uterine dehiscences vs one, one vs four maternal infections, five vs two hemorrhages and 11 vs five neonatal transfers, respectively. Heterogeneity of treatment effect for vaginal delivery was observed across initial Bishop scores. Balloon catheter was more effective for low values of bishop score. CONCLUSIONS: Balloon catheter tended to be associated with a higher probability of vaginal delivery as compared with low-dose intravenous oxytocin when used for induction of labor in women with a previous cesarean section and low Bishop score at induction.

Trial of labor versus elective cesarean delivery for patients with two prior cesarean-sections: A retrospective propensity score analysis.

INTRODUCTION: Despite awareness of obstetricians to the constant increase in the number of cesarean sections in recent years, the fear of a uterine scar rupture is still present and influences the choice of the mode of delivery in patients with two previous cesarean sections. However, several clinical studies have suggested that, under certain conditions, vaginal birth after two cesarean sections is usually successful and safe. OBJECTIVE: The objective of this study was to compare maternal and neonatal issues according to the planned mode of delivery in patients with two previous cesarean sections. METHODS: It was a retrospective observational comparative study at Rennes University Hospital between January 1, 2013, and December 31, 2020. We performed a propensity score for the comparison of neonatal outcomes: cord pH, cord lactates, Apgar scores, transfer to neonatal unit and deaths, according to the planned delivery mode. Secondary outcomes were maternal issues: uterine rupture, post-partum hemorrhage, deaths. RESULTS: A total of 410 patients with two previous cesarean section were eligible for our study. Prophylactic cesarean was performed in 358 cases (87.3%). Trial of labor was attempted in the 52 remaining patients (12.7%), 67.3 % of whom were successful. Neonatal weight, APGAR score at 1-5-10 min, and pH on cord blood were comparable in both groups. One case of uterine rupture occurred in the trial of labor group. CONCLUSION: Trial of labor seems to be a reasonable option for women with two previous cesarean sections in a selected population.

Assessment of compliance with a color code protocol for non-elective cesarean section and its impact on time to delivery interval and neonatal outcomes.

INTRODUCTION: We set out to assess the compliance with a cesarean section color code protocol and its impact on maternal and neonatal outcomes since its implementation in our maternity ward. METHODS: This was a retrospective study including a sample of 200 patients per year who underwent a non-elective cesarean section delivery in Rennes University Hospital from January 1, 2015 to December 31, 2018. Patients were grouped by year and by color code (red, orange or green). The main outcome was compliance with the protocol (color code in accordance with indication for cesarean section) and compliance with the corresponding decision-delivery interval. Secondary outcomes were maternal and neonatal outcomes. RESULTS: Eight hundred patients were included during the study period. There was no significant difference in patient characteristics over the years. There was a significant improvement in protocol compliance: full compliance increased from 22.4% in 2015 to 76.5% in 2018 (p < 0.0001). The respect of the 15 min decision-delivery interval in red code protocol increased between 2015 and 2018 (p = 0.0020). CONCLUSION: We observed a significant improvement in compliance with the color code protocol between 2015 and 2018 and in the 15 min decision-delivery deadline for the red code.

Operative Technique and Experience of One Referral Center With Vaginal Cesarean Delivery.

BACKGROUND: To report the experience of vaginal cesarean delivery and describe the surgical technique. METHOD: This is a retrospective case series from one referral center of patients who underwent vaginal cesarean delivery from 2000 to 2017, presenting a step-by-step operative technique with a video. The operative technique consists of: 1) development of a transvaginal bladder flap by dissecting the bladder off the cervix, thereby exposing the lower uterine segment; 2) making a vertical segment incision up to the highest part of the lower uterine segment, just below the muscular portion of the uterus; 3) extraction of the fetus; and 4) reconstruction of the lower uterine segment and vagina. EXPERIENCE: Seven patients with maternal indications for urgent premature delivery who underwent vaginal cesarean delivery were included. Indications were severe bleeding (n=3), severe previable preeclampsia (n=2), severe heart failure (n=1), and stroke (n=1). The average gestational age at delivery was 21 2/7 weeks (18 2/7-24 1/7 weeks); median fetal birth weight was 300 g (179-500 g). There were no intraoperative complications attributable to the procedure. CONCLUSION: Vaginal cesarean delivery is a valuable technique for rapid fetal extraction of deceased or nonviable fetuses for severe maternal indications.

Caesarean section at term: the relationship between neonatal respiratory morbidity and microviscosity in amniotic fluid.

OBJECTIVES: The incidence of neonatal respiratory morbidity following an elective caesarean section is 2-3 times higher than after a vaginal delivery. The microviscosity of surfactant phospholipids, as measured with fluorescence polarisation, is linked with the functional characteristics of fetal surfactant and thus fetal lung maturity, but so far this point has received little attention in newborns at term. The aim of the study is to evaluate the correlation between neonatal respiratory morbidity and amniotic microviscosity (Fluorescence Polarisation Index) in women undergoing caesarean section after 37 weeks' gestation. STUDY DESIGN: The files of 136 women who had undergone amniotic microviscosity studies during elective caesarean deliveries at term were anonymised. Amniotic fluid immaturity (AFI) was defined as a Fluorescence Polarisation Index higher than 0.335. RESULTS: Respiratory morbidity was observed in 10 babies (7.3%) and was independently associated with AFI (OR: 6.11 [95% CI, 1.20-31.1] with p=0.029) and maternal body mass index (OR: 1.12 [95% CI, 1.02-1.22] with p=0.019). Gestational age at the time of caesarean delivery was inversely associated with AFI (odds ratio, 0.46 [95% confidence interval, 0.29-0.71], p<0.001), especially before 39 weeks, and female gender was associated with an increased risk (odds ratio, 3.29 [95% confidence interval, 1.48-7.31], p=0.004). CONCLUSIONS: AFI assessed by amniotic microviscosity was significantly associated with respiratory morbidity and independently correlated with shorter gestational age especially before 39 weeks. This finding provides a physiological rationale for recommending delaying elective caesarean section delivery until 39 weeks of gestation to decrease the risk for respiratory morbidity.