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oxytocin rct 2010-04 ClinicalTrials

Intracervical Catheters Explored for Labor Induction After Membrane Rupture

Intracervical Catheters for Induction of Labour in Women With Prelabour Rupture of Membranes at Term

Background

Prelabor rupture of membranes (PROM) at term, where the amniotic sac breaks before labor begins, affects a significant number of pregnancies and often necessitates induction of labor to prevent complications like infection. Current methods for induction vary, but there's a continuous search for safer and more effective approaches. This pilot study aimed to evaluate the feasibility of using intracervical balloon catheters for cervical ripening in women with PROM at term.

Study Design

Population
Five women with prelabor rupture of membranes at term were enrolled in this prematurely terminated pilot study.
Intervention
The intervention involved the use of an intracervical balloon catheter for labor induction.
Comparator
Oxytocin alone was used as the comparator for labor induction.
Outcome
The primary objective was to evaluate the feasibility of using intracervical balloon catheters for cervical ripening, including metrics like time to delivery or success rates, but no definitive data was reported due to premature termination.

Results

The study was terminated prematurely after enrolling only 5 participants, a significantly lower number than required for a robust pilot assessment. Consequently, no definitive efficacy or safety data comparing the intracervical balloon catheter method with oxytocin alone for labor induction in women with prelabor rupture of membranes at term was reported. > The premature termination meant that the primary objective of assessing the feasibility of intracervical balloon catheters for cervical ripening, including metrics like time to delivery or success rates, could not be fully evaluated or compared between groups. Therefore, no quantitative comparisons regarding key outcomes such as the average time from induction to delivery, the rate of successful vaginal deliveries, or the incidence of maternal and fetal complications (e.g., infection, fetal distress) could be established from this specific trial. The extremely limited enrollment of 5 subjects provided insufficient data to draw any conclusions about the comparative effectiveness, safety profile, or even the practical feasibility of the interventions.


oxytocin safety data present
Source: clinicaltrials:NCT00890630 · Ingested 2026-04-24 · Digest: gemini-2.5-flash