A Phase 4 interventional study of Balloon for cervical ripening (Teleflex French Dufour catheter CH20 reference 174000) and Oxytocin in Induction of Labor, Cervical Ripening and Premature Rupture of Fetal Membranes, sponsored by University Hospital, Clermont-Ferrand. Recruiting at 5 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-25.
Sponsored by University Hospital, Clermont-Ferrand · Phase 4, Interventional, and Treatment
Premature rupture of membranes (PROM) at term complicates 6 to 22% of singleton pregnancies. Spontaneous labour occurs in 60-67% of these patients within 24h. If no effective uterine contraction occurs, induction of labour (IOL) is the strategy recommended by the French as well as the American College of Obstetricians and Gynecologists. The optimal strategy for IOL in case of PROM with an unfavourable cervix remains unknown and none of the studies conducted in nulliparous women showed the superiority of one induction method over another.
In the current project, we aimed to determine (1) if IOL with association of balloon catheter and oxytocin after 6 hours could increase the rate of delivery \< 24h versus low dose of oral misoprostol (25 µg oral PGE1 every 2h) in case of PROM at term in nulliparous women and (2) patient satisfaction using EXIT survey assessed before hospital discharge.
Context : Premature rupture of membranes (PROM) at term complicates 6 to 22% of singleton pregnancies. Spontaneous labour occurs in 60-67% of these patients within 24hours. If no effective uterine contraction occurs, induction of labour (IOL) is the strategy recommended by the French as well as the American College of Obstetricians and Gynecologists. The optimal strategy for IOL in case of PROM with an unfavourable cervix remains unknown and none of the studies conducted in nulliparous women showed the superiority of one induction method over another1. Oral misoprostol (ProstaglandinE1, PGE1) usually demonstrated the lowest rate of c-section after IOL in general population and balloon catheter was associated with the lowest rate of uterine hyperstimulation. Recently, a comparison 1 to 1 between these two methods was conducted in singletons with comparable results. Despite recent studies demonstrating no higher risk of infectious complications using mechanical device in the context of PROM, only prostaglandins and oxytocin are usually recommended. Recently, Devillard et al. demonstrated that the combination of balloon catheter plus oxytocin systematically infused after 6 hours increased the rate of delivery \<24h compared to dinoprostone vaginal insert group (90% versus 57.5% respectively) and decreased the time between induction and delivery in nulliparous group (17.0hours versus 26.5hours).
In the current project, we aimed to determine (1) if IOL with association of balloon catheter and oxytocin after 6 hours could increase the rate of delivery \< 24hours versus low dose of oral misoprostol (25 µg oral PGE1 every 2h) in case of PROM at term in nulliparous women and (2) patient satisfaction using EXIT (EXperience of Induction Tool) survey assessed before hospital discharge.
We hypothesized that the rate of delivery \< 24hours will be 15% higher in the group induced with balloon + oxytocin (estimated around 85 %) compared to the misoprostol group (estimated around 70 %). Patient satisfaction concerning experience of IOL will be assessed using a validated survey- the EXperience of Induction Tool (EXIT) - translated in French language (Beckman et al., 2017). We aimed to demonstrate a difference greater than an effect-size of 0.25.
Objectives: The main objective is to demonstrate higher rate of vaginal birth \<24hours by insertion of a balloon catheter + oxytocin after 6hours, versus low dose of oral misoprostol (25 µg oral PGE1 every 2hours) in case of unfavorable cervix beyond 12 hours of PROM in nulliparous and to compare patient satisfaction using EXIT survey translated in French language before hospital discharge.
The secondary objectives are:
Study type: Multi-center, randomized, controlled, open-label therapeutic trial with two parallel arms.
Number of centers: 5
Study Description:
The study group is the balloon catheter group with addition of oxytocin as early as 6h after the catheter insertion. After 12 hours of balloon insertion, induction of labour is continued by oxytocin alone. The control group corresponds to induction with misoprostol 25µg given orally (oral prostaglandin E1). The same dose is delivered every 2 hours until labour onset with a maximum of 8 administrations. Oxytocin can be started at least 4 hours after the last misoprostol administration.
Patients will be assigned by random allocation on a 1:1 basis in permuted blocks to either treatment group or control group using a dedicated, password-protected, SSL-encrypted website. To minimize the risk of imbalance between the study groups, the randomization will be stratified by trial site.
Primary endpoint: Hierarchical primary endpoint: (1) Proportion of patients vaginally delivered \<24h and (2) patient satisfaction using EXIT survey assessed before hospital discharge.
Number of patients: 520
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 520 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
Contraindication to misoprostol:
Contraindication to balloon:
Contraindication to oxytocin
Mecanical cervical ripening will be done by transcervical balloon (Teleflex French Dufour catheter CH20 reference 174000). Oxytocin will be started 6 hours after balloon insertion. At H12 balloon will be removed and induction continued by oxytocin alone.
Device: Balloon for cervical ripening (Teleflex French Dufour catheter CH20 reference 174000) · Drug: Oxytocin
Patients will receive misoprostol 25 micrograms given orally (oral prostaglandin E1). The same dose will be given every 2 hours until beginning of labor with a maximum of 8 administrations. (Oxytocin can be started at least 4 hours after the last misoprostol administration if patient remains not in labour.)
Drug: Misoprostol Oral Tablet
Balloon catheter is inserted by a resident or a physician under visual control. The expected volume injected in the balloon probe is 60 mL. No traction is performed on the catheter. The catheter is left in place for a maximum of 12 hours.
Intravenous oxytocin addition (preceded or followed by epidural analgesia on patient's request) will be performed 6 hours after insertion of balloon catheter. Oxytocin is administered as an intravenous infusion (5 IU of oxytocin in 49 mL of 5% glucose\*) at the lowest possible dose with the aim of achieving a maximum of three to four contractions per ten minutes. After appropriate uterine activity has been achieved, the rate of the oxytocin infusion is decreased or stopped.
Patients will receive misoprostol 25 micrograms given orally (oral prostaglandin E1). The same dose will be given every 2 hours until beginning of labor with a maximum of 8 administrations.
Vaginal delivery <24hours
Proportion of patients vaginally delivered \<24hours (in %)
Time frame: at birth
Patient satisfaction
Satisfaction of women concerning method of induction by the EXperience of Induction Tool (EXIT) validated in french language.
Time frame: up to 4 days
Duration from rupture to beginning of induction
in hours
Time frame: at birth
Duration between IOL and delivery
in hours
Time frame: at birth
Duration of balloon exposure or misoprostol exposure
in hours
Time frame: at birth
Misoprostol received
Total dose of misoprostol received (in µg)
Time frame: at birth
Bishop score on balloon removal
(comprised between 0 and 13)
Time frame: at birth
Balloon in place (yes/no)
Rate of balloon in place (%) at 12 hours after the beginning of induction
Time frame: at birth
Duration between induction and full cervical dilatation
Duration (in hours)
Time frame: at birth
Mode of delivery
Rate in %
Time frame: at birth
Post-partum hemorrhage
Rate in %
Time frame: up to 4 days
Rate of fever
Rate in %
Time frame: during labor
Rate of patients experiencing episode(s) of uterine hyperstimulation
Rate of patients experiencing episode(s) of uterine hyperstimulation (%) during labour (defined by the necessity to interrupt oxytocin and/or to inject pharmacological agents in the context of excessive number of contractions with or without abnormal FHR),
Time frame: during labor
Endometritis
Rate of endometritis in %
Time frame: up to 4 days
Duration of hospital stay
Duration (in days)
Time frame: up to 4 days
Birth weight of the newborn
in grammes
Time frame: at birth
Apgar score < 7
Neonatal endpoint (yes/no)
Time frame: 5min after birth
pH umbilical artery
pH at the umbilical artery
Time frame: at birth
Base defect and lactate (umbilical artery)
mmol/L
Time frame: at birth
Neonatal tranfer
Rate of neonatal transfer to intensive care unit or neonatology unit
Time frame: up to 4 days
maternal-fetal infection
Rate of maternal-fetal infection in %
Time frame: up to 4 days
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University Hospital, Clermont-Ferrand