Cervical balloon catheter versus Dilapan-S for outpatient cervical ripening: A randomized controlled trial.

As induction of labor increases in the United States, safe, effective outpatient cervical ripening has been explored as a method to decrease the inpatient time burden. The most effective method of outpatient mechanical cervical ripening remains unclear. To evaluate if Dilapan-S is non-inferior to cervical balloon for outpatient cervical ripening (CR) based on change in Bishop score. This was a single-blind, randomized controlled trial at a single tertiary hospital. Term patients, both nulliparous and multiparous, aged 18-50 with a singleton, cephalic fetus and no prior c-section who were scheduled for outpatient CR per pre-existing hospital policy were eligible. Participants were randomized to single balloon cervical ripening with a Cook catheter with 60mL in the intrauterine balloon or placement of 3 to 5 Dilapan-S hydroscopic dilators and were then discharged home. On return to the hospital, the CR agent was removed, a blinded cervical exam performed, and participants completed a satisfaction survey. Further induction proceeded per their obstetrical provider. The primary outcome was change in Bishop score. Secondary outcomes included patient satisfaction, mode of delivery, induction time, adverse maternal and neonatal outcomes and a cervical ripening failure composite (failure to place randomized cervical ripening agent, prelabor rupture of membranes prior to scheduled return to hospital, significant vaginal bleeding, or need for further cervical ripening after the initial agent is removed) .We had 80% power to show non-inferiority in change in Bishop score with a margin of 2 and standard deviation of 3. From May 2022 to June 2023, 80 participants were randomized with no difference in baseline demographic data, starting dilation, or Bishop score. 70% of participants in each arm were nulliparous. There was no difference in change in Bishop score between Dilapan-S and cervical balloon (median change 3 (interquartile range (IQR) 2-5) vs 3 (IQR2-4.5) respectively, p=0.91). There was no difference in time to delivery, mode of delivery, or maternal or neonatal outcomes. Participants randomized to Dilapan-S were more satisfied with their experience (satisfaction scale 0-10, median 9 (IQR 8-10) vs 8 (IQR 5-9), p<0.01) and were less likely to experience cervical ripening failure (7(17.5%) vs 18(45%), p<0.01) compared to participants who were randomized to cervical balloon. Dilapan-S was non-inferior to cervical balloon catheter for outpatient cervical ripening based on change in Bishop score. Participants were more satisfied with Dilapan-S and less likely to experience cervical ripening failure compared to a cervical catheter with single balloon inflation.

Wood RL ，Bluemm C ，Lassey SC ，Little SE ... -  《-》

Dilapan-S vs standard methods for cervical ripening in term pregnancies: an individual patient data meta-analysis.

Dilapan-S is a cervical ripening agent approved by the FDA that has been found to be just as effective as other agents and can be utilized for outpatient ripening. No large-scale studies have been conducted to compare cesarean delivery rates between Dilapan-S and other ripening methods. Our objective was to combine these trials to compare cesarean delivery rates for Dilapan-S with other cervical ripening methods, overall and in sub-groups. The time period for this study was from January 1994 to April 2023. Ovid MEDLINE, Embase via Ovid, Ovid Emcare, CINAHL Plus, ClinicalTrials.gov, euclinicaltrialsregister.eu, and Scopus were searched. The study was conducted according to the Preferred Reporting Item for Systematic Reviews guidelines and was registered with PROSPERO (CRD42023423573). This was a systematic review and meta-analysis of individual patient data from randomized controlled trials comparing Dilapan-S to other mechanical or pharmacologic cervical ripening methods for labor induction in singleton gestations. The main outcome measure assessed was the cesarean delivery (CD) rate in comparing Dilapan-S to alternative methods. Secondary maternal outcomes included changes in Bishop score postintervention, vaginal delivery without complications, postpartum hemorrhage, cervical ripening issues, uterine infection, and patient satisfaction. Secondary neonatal outcomes were Apgar score <7 at 5 minutes, arterial cord pH <7.1, meconium presence, NICU admission and length of stay, hypoxic-ischemic encephalopathy, intraventricular hemorrhage, infant infection, and infant death. This study exclusively included randomized controlled trials (RCTs) involving participants who underwent labor induction during the third trimester of a singleton pregnancy. At least one group within these trials received Dilapan-S for the purpose of cervical ripening. Trials were excluded if induction occurred prior to 37 weeks of gestation or if cervical ripening was deemed unnecessary. Two reviewers independently selected studies, assessed the risk of bias using the Cochrane Risk of Bias Tool for RCTs, and extracted the data. Prespecified subgroup analysis was performed for parity, body mass index, Bishop score, and gestational age. Pooled odds ratios (ORs) adjusted for maternal age and parity with 95% confidence intervals (CI) were calculated using frequentist and Bayesian approaches. Four RCTs were identified, with 1731 women included (1036 allocated to Dilapan-S; 695 to alternative cervical ripening methods). CD rates were 28% and 30% with Dilapan-S and other methods, respectively. There was no difference in maternal age and parity-adjusted CD rates between Dilapan-S and other methods (OR 1.03, 95% CI 0.8-1.3). Bayesian inference indicated a 95% probability of being noninferior (5% margin) and a 4.5% probability of being inferior to other methods. Subgroup analysis demonstrated significant interaction with parity with a 99% probability of lowering cesarean rates among multiparous women treated with Dilapan-S (RR 0.61, 95% CrI 0.4-0.9) compared to a 6% probability of benefit among nulliparous women (RR 1.13, 95% CrI 0.97-1.33). Pain levels ≥4 were significantly lower in the Dilapan-S group (46% vs 62%; OR 0.5, 95% CI 0.40-0.64). Complication rates during cervical ripening (uterine hypertonus, uterine tachysystole, nonreassuring fetal heart tracing, and others) were also lower in the Dilapan-S group (19% vs 47%; OR 0.28, 95% CI 0.28-0.37). Higher patient satisfaction was reported with Dilapan-S. Dilapan-S was at least noninferior and marginally superior in lowering cesarean rates compared to other preinduction cervical ripening agents. Parity impacted efficacy, with multiparous women benefiting the most.

Saad AF ，Pedroza C ，Gavara R ，Gupta J ，Wapner RJ ，Saade GR ... -  《-》

Cervical ripening at home or in hospital during induction of labour: the CHOICE prospective cohort study, process evaluation and economic analysis.

Black M ，Yuill C ，Harkness M ，Ahmed S ，Williams L ，Boyd KA ，Reid M ，Bhide A ，Heera N ，Huddleston J ，Modi N ，Norrie J ，Pasupathy D ，Sanders J ，Smith GCS ，Townsend R ，Cheyne H ，McCourt C ，Stock S ... -  《-》

Tugging the Foley catheter balloon every three hours in induction of labor after one previous cesarean: a randomized controlled trial.

Induction of labor after 1 previous cesarean delivery with an unripe cervix have an especially high risk for unplanned cesarean delivery and uterine rupture. Mechanical balloon ripening is often preferred over prostaglandin-based ripening during induction of labor after 1 previous cesarean delivery, because uterine rupture has been associated with prostaglandin use. The transcervical Foley balloon can be dislodged past the ripened cervix and be retained comfortably in the vagina during passive placement. Tugging of the Foley catheter can be a noninvasive and tolerated method for timelier retrieval of the retained balloon; expediting discovery of a ripened cervix would permit an earlier follow-on amniotomy and oxytocin infusion, thereby hastening birth. This study aimed to evaluate the effect of tugging of the Foley balloon for 30 seconds every 3 hours during 12 hours of scheduled placement in comparison with standard care (no tugging) on the induction to birth interval and patient satisfaction. This randomized controlled trial, conducted at a university hospital in Malaysia, recruited participants from April 2023 to March 2024. Eligible participants admitted for Foley balloon induction of labor who had 1 previous cesarean were recruited. After balloon insertion, participants were randomized to tugging or standard care. Following balloon displacement, a vaginal examination was performed to check the cervix. The examination findings then dictated the follow-on management of induction of labor after 1 previous cesarean according to standard practice. The primary outcomes were the induction (Foley insertion) to delivery interval and participants' satisfaction with the birthing process. Secondary outcomes were largely derived from the core outcome set for trials on induction of labor. Based on a superiority hypothesis, it was calculated that a sample size of 126 would be required to detect a 4-hour reduction in the induction-to-delivery interval and a 1.5 point increase in the satisfaction score based on a 0 to 10 numerical rating scale with the level of significance set at 0.05, power at 80%, and a 10% drop out rate. Comparative analyses using an intention-to-treat approach were conducted using t tests, Mann-Whitney U tests, chi square tests, and Fisher exact tests as appropriate. A total of 126 participants were randomized with 63 in each trial arm. The induction to birth interval was (mean ± standard deviation) 29.7±9.6 hours for those in the 3-hourly tugging group and 29.8±9.1 hours for those under standard care (P=.950), and maternal satisfaction with the induction of labor after 1 previous cesarean delivery birth process, assessed using a 0 to 10 numerical rating scale, was (median [interquartile range]) 8 [7-9] and 8 [7-9] (P=.936), respectively. The cesarean delivery rate was 37 of 63 (59%) vs 41 of 63 (65%) (P=.238) for those in the tugging group vs standard care, and the main indication for unplanned cesarean delivery was failure to progress with an incidence of 24 of 37 (65%) and 24 of 41 (59%) (P=.914) for tugging vs standard care arms, respectively. Three-hourly tugging also did not shorten the interval from induction to balloon displacement, amniotomy, the start of oxytocin infusion, or the second stage of labor. Tugging the catheter every 3 hours during scheduled 12-hour Foley balloon placement for induction of labor after 1 previous cesarean delivery did not hasten birth or improve patient satisfaction when compared with standard care.

Yunesh K ，Adlan ASA ，Wong TY ，Gan F ，Hamdan M ，Tan PC ... -  《-》

Erratum: Eyestalk Ablation to Increase Ovarian Maturation in Mud Crabs.

《Jove-Journal of Visualized Experiments》