Marta Jozwiak

Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term (PROBAAT trial): an open-label, randomised controlled trial

BACKGROUND Induction of labour is a common obstetric procedure. Both mechanical (eg, Foley catheters) and pharmacological methods (eg, prostaglandins) are used for induction of labour in women with an unfavourable cervix. We aimed to compare the effectiveness and safety of induction of labour with a Foley catheter with induction with vaginal prostaglandin E2 gel. METHODS We did an open-label, randomised controlled trial in 12 hospitals in the Netherlands between Feb 10, 2009, and May 17, 2010. We enrolled women with a term singleton pregnancy in cephalic presentation, intact membranes, an unfavourable cervix, an indication for induction of labour, and no prior caesarean section. Participants were randomly allocated by an online randomisation system to induction of labour with a 30 mL Foley catheter or vaginal prostaglandin E2 gel (1:1 ratio). Because of the nature of the intervention this study was not blinded. The primary outcome was caesarean section rate. Secondary outcomes were maternal and neonatal morbidity and time from intervention to birth. All analyses were done on an intention-to-treat basis. We also did a meta-analysis that included our trial. The trial was registered with the Dutch trial registry, number NTR 1646. FINDINGS 824 women were allocated to induction of labour with a Foley catheter (n=412) or vaginal prostaglandin E2 gel (n=412). Caesarean section rates were much the same between the two groups (23%vs 20%, risk ratio [RR] 1·13, 95% CI 0·87-1·47). A meta-analysis including our trial data confirmed that a Foley catheter did not reduce caesarean section rates. We recorded two serious maternal adverse events, both in the prostaglandin group: one uterine perforation and one uterine rupture. INTERPRETATION In women with an unfavourable cervix at term, induction of labour with a Foley catheter is similar to induction of labour with prostaglandin E2 gel, with fewer maternal and neonatal side-effects. FUNDING None.

Cervical ripening with Foley catheter for induction of labor after cesarean section: a cohort study

To evaluate spontaneous vaginal delivery and complication rates after induction of labor with a transcervical Foley catheter in women with a previous cesarean delivery.

Foley catheter versus vaginal misoprostol: randomized controlled trial (PROBAAT-M study) and systematic review and meta-analysis of literature

OBJECTIVES To assess effectiveness and safety of Foley catheter versus vaginal misoprostol for term induction of labor. STUDY DESIGN This trial randomly allocated women with singleton term pregnancy to 30-mL Foley catheter or 25-μg vaginal misoprostol tablets. Primary outcome was cesarean delivery rate. Secondary outcomes were maternal and neonatal morbidity and time to birth. Additionally, a systematic review was conducted. RESULTS Fifty-six women were allocated to Foley catheter, 64 to vaginal misoprostol tablets. Cesarean delivery rates did not differ significantly (25% Foley versus 17% misoprostol; relative risk [RR] 1.46, 95% confidence interval [CI] 0.72 to 2.94), with more cesarean deliveries due to failure to progress in the Foley group (14% versus 3%; RR 4.57, 95% CI 1.01 to 20.64). Maternal and neonatal outcomes were comparable. Time from induction to birth was longer in the Foley catheter group (36 hours versus 25 hours; p < 0.001). Meta-analysis showed no difference in cesarean delivery rate and reduced vaginal instrumental deliveries and hyperstimulation in the Foley catheter group. Other outcomes were not different. CONCLUSION Our trial and meta-analysis showed no difference in cesarean delivery rates and less hyperstimulation with fetal heart rate changes and vaginal instrumental deliveries when using Foley catheter, thereby supporting potential advantages of the Foley catheter over misoprostol as ripening agent.

Cervical Ripening in The Netherlands: A Survey

Objective. We aim to investigate methods and use of cervical ripening in women without and with a prior cesarean delivery in The Netherlands. Methods. In 2010, we conducted a postal survey in all Dutch hospitals with a labor ward. One gynecologist per hospital was addressed and was asked to respond on behalf of the staff. The questionnaire contained 31 questions concerning cervical ripening and induction of labor. We compared this survey to a similar Dutch survey conducted in 2006. Results. Response rate was 78% (70/92 hospitals). In women without a prior cesarean and in need of cervical ripening, all hospitals (100%) applied prostaglandins (either E1 or E2). In women with a prior cesarean, 21.4% of the hospitals performed an elective cesarean section if delivery was indicated (26.0% in 2006). In case of cervical ripening, 72.7% used mechanical methods (49.1% in 2006), 20.0% used prostaglandins (40.4% in 2006), 3.6% used a combination of prostaglandins and mechanical methods, and 3.6% used membrane-sweeping or oxytocin. Conclusions. In 2010, in The Netherlands, prostaglandins and Foley catheters were the preferred methods for cervical ripening in women without and with a prior cesarean, respectively. Use of mechanical methods in women with a prior cesarean has increased rapidly between 2006 and 2010, corresponding with decreasing use of prostaglandins and elective repeat cesarean sections.

Women's Experiences with and Preference for Induction of Labor with Oral Misoprostol or Foley Catheter at Term

Objective We assessed experience and preferences among term women undergoing induction of labor with oral misoprostol or Foley catheter. Study Design In 18 of the 29 participating hospitals in the PROBAAT‐II trial, women were asked to complete a questionnaire within 24 hours after delivery. We adapted a validated questionnaire about expectancy and experience of labor and asked women whether they would prefer the same method again in a future pregnancy. Results The questionnaire was completed by 502 (72%) of 695 eligible women; 273 (54%) had been randomly allocated to oral misoprostol and 229 (46%) to Foley catheter. Experience of the duration of labor, pain during labor, general satisfaction with labor, and feelings of control and fear related to their expectation were comparable between both the groups. In the oral misoprostol group, 6% of the women would prefer the other method if induction is necessary in future pregnancy, versus 12% in the Foley catheter group (risk ratio: 0.70; 95% confidence interval: 0.55‐0.90; p = 0.02). Conclusion Womens experiences of labor after induction with oral misoprostol or Foley catheter are comparable. However, women in the Foley catheter group prefer more often to choose a different method for future inductions.

Induction of labour at term with oral misoprostol versus a foley catheter (PROBAAT-II) : A multicentre randomised controlled non-inferiority trial

When pregnancy complications pose a threat to the mother or fetus or both, induction of labor is often required. Induction of labor is accomplished through a variety of methods; in pregnant women having an unfavourable cervix, cervical ripening of the cervix is accomplished through various mechanical and pharmacological means. Oral misoprostol and Foley catheter are believed to be equally effective in women with an unfavorable cervix in accomplishing vaginal birth. The current open-label randomized noninferiority trial was conducted in pregnant women with a singleton gestation in 29 hospitals in the Netherlands (2012 to 2013) to directly compare oral misoprostol with Foley catheter. Women with a viable singleton pregnancy in cephalic presentation, intact membranes, gestational age of 37 weeks or more, and an unfavorable cervix were included in the trial. The women were then randomly allocated (1:1) to oral misoprostol (n = 932) or Foley catheter (n = 927). Oral misoprostol dosage given was 50 µg orally once every 4 hours with a maximum of 3 times a day. Placement of a 30-mL Foley catheter in the cervix was done either digitally or using a vaginal speculum. The results of the study showed that the primary outcome (asphyxia or postpartum hemorrhage) occurred in 12.2% women in the misoprostol group and in 11.5% women in the Foley catheter group (adjusted relative risk [RR], 1.06; 90% confidence interval [CI], 0.86–1.31). Cesarean delivery resulted in 16.8% of labors in the misoprostol group and in 20.1% of the time in the Foley catheter group (no significant difference between groups [RR, 0.84; 95% CI, 0.69–1.01]). When the indication for cesarean delivery was examined, fewer cesarean deliveries for failure to progress in the first stage occurred after induction in the misoprostol group than in the Foley catheter group (6.2% vs 10.6%; RR, 0.58; 95% CI, 0.42–0.79). In addition, operative vaginal delivery occurred more frequently in the misoprostol group. Among the misoprostol group spontaneous membrane rupture was more common and labor augmentation with oxytocin was less likely. The study leads to a conclusion that in terms of safety and effectiveness, induction of labour using oral misoprostol is as safe as mechanical induction using Foley catheter.