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Clinical Trial

Balloon + Oxytocin Versus Oral Misoprostol to Induce Labor in Case of PROM (RUBAPRO2)

NCT: NCT05568745 · TERMINATED

NCT IDNCT05568745
StatusTERMINATED
Start Date2023-01-18
Completion2025-08-29
SponsorUniversity Hospital, Clermont-Ferrand (OTHER)
First posted
Last updated

Brief Summary

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.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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