Oxytocin vs. Prostaglandin for Induction of Labor in Primiparas With Prelabor Rupture of Membrane and Low Bishop

What Was Tested

The trial (phase 4) is built around Oxytocin.

The purpose of the study is to compare between oxytocin to prostaglandin (PGE2), regarding time from induction of labor (IOL) to delivery among primiparas at term with prelabor rupture of membrane (PROM) and an unfavorable cervix.

It had two arms (groups): Oxytocin (experimental) and Prostaglandin E2 (experimental).

The registry classes the interventions as drug.

More on the Plan

Their secondary outcome is to compare between the groups regarding obstetric complications including: cesarean delivery, operative vaginal delivery, maternal intrapartum fever, postpartum hemorrhage, Apgar score at 5 minutes ≤ 7, PH, admission to NICU and the time from initiation of induction to active labor.

The study population will include primiparous at term with PROM and unfavorable bishop score (≤3).

Subsequent to confirming inclusion criteria and after receiving informed consent parturients will be randomly allocated to receive oxytocin or PGE2.

Induction with oxytocin (group 1) will be initiated by infusion of intravenous oxytocin: 2.5 mIU per minute with increments of 2.5 mIU every 20 minutes until achieving 4-5 contractions during 10 minutes.

Who Took Part

Enrollment: 68 planned participants were the target.

It was open to women only aged from 18 years up to 38 years.

Healthy volunteers could join, not only people with the condition.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Oxytocin study did not mask who received what.

It started in 2016-09 with completion listed for 2017-09.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time from induction of labor to delivery comparing between oxytocin and PGE2 among primiparas with prelabor rupture of membrane at term and low Bishop score (≤ 3) regarding the time needed to complete a vaginal delivery (time frame: up to 48 hours).

It also tracked 6 secondary outcomes, for example cesarean delivery, operative vaginal delivery, maternal intrapartum fever, postpartum hemorrhage, Apgar score at 5 minutes ≤ 7 and admission to NICU.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 68 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.