Induction of labour in case of premature rupture of membranes at term with an unfavourable cervix: protocol for a randomised controlled trial comparing double balloon catheter (+oxytocin) and vaginal prostaglandin (RUBAPRO) treatments

Abstract

IntroductionPremature rupture of membranes (PROM) occurs at term in 8% of pregnancies. Several studies have demonstrated that the risk of chorioamnionitis and neonatal sepsis increases with duration of PROM. Decreasing the time interval between PROM and delivery is associated with lower rates of maternal infections. In case of an unfavourable cervix, the use of prostaglandin for cervical maturation demonstrates some advantages over oxytocin. The use of double balloon catheter in reduction of PROM duration has not been evaluated in the literature.Methods and analysisWe are conducting a prospective, monocentric, randomised clinical trial on pregnant women with an unfavourable cervix showing PROM at term (RUBAPRO).After 12–24 hours of PROM, women are randomly assigned to one group treated with a double balloon catheter for 12 hours, with oxytocin administered after 6 hours or to the control group treated with 24 hours of vaginal prostaglandin followed by oxytocin infusion alone. Patients (n=80) are randomised at a 1:1 ratio with stratification on parity.The inclusion criteria are a Bishop score of <6, cephalic presentation at term and confirmed PROM. Women with suspected chorioamnionitis; group B streptococcus (GBS) carrier; a history of caesarean delivery or any contraindication for vaginal delivery are excluded.The time from induction to delivery is the primary outcome. Secondary outcomes were mode of delivery, maternofetal morbidity and the effect of parity on strategies for reduction of PROM duration.To sufficiently demonstrate a difference (10 hours) between groups—with a statistical power of 90% and a two-tailed α of 5%—40 patients per group will be required.Ethics and disseminationWritten informed consent is required from participants.National Ethics Committee approval was obtained in August 2017. The results will be published in a peer-reviewed journal and presented at relevant conferences. Access to raw data will be available only to members of the research team.Trial registration numberNCT03310333.

RETRACTED: Isosorbide mononitrate for cervical ripening in induction of labor for pregnant women with PROM at or post term

“…An extended interval from membrane rupture to delivery is associated with a greater risk of maternal and neonatal infection. 1 The management of women with PROM at term, particularly those with an unfavorable cervix, remains debatable. Treatment options range from conservative management or immediate labor induction to delayed induction with vaginal or oral prostaglandin, mechanical methods, or intravenous oxytocin.…”

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

“…The nature of the intervention rendered the blinding of physicians, midwives, or patients impossible. The protocol was published on the BMJ open website [ 16 ], and the main study stages are described in Figure 1 .…”

Evaluating misoprostol and mechanical methods for induction of labour

“…Results of randomised trials 11 of women with ruptured membranes have similar findings to those when the membranes are intact: those induced with oral misoprostol rather than dinoprostone have fewer caesarean births and less hyperstimulation. The use of mechanical methods has not been widely studied in prelabour rupture of membranes, but a randomised trial 29 is ongoing. Only one study 30 of 202 women has directly compared oral misoprostol to balloon catheter and no differences in outcomes were reported.…”