Oxytocin in Multiparous Women

What Was Tested

The trial (not phased) is built around Oxytocin.

This is a randomized controlled trial investigating whether continuous oxytocin infusion in multiparous women shortens time to delivery, without altering maternal or neonatal outcomes, in augmented deliveries, compared to intermittent infusion.

It had two arms (groups): continuous oxytocin infusion (experimental) and intermittent oxytocin infusion (active comparator).

Continuous oxytocin infusion - women will continue to receive a continuous oxytocin infusion from start of labor augmentation until delivery.

Intermittent oxytocin infusion - oxytocin transfusion will be discontinued after 8 hours if the woman does not go into active labor, or does not deliver in that period of time. The second course of oxytocin will be renewed after 6 hours if the woman hasn't progressed into labor or hasn't given birth yet.

The registry classes the interventions as drug.

More on the Plan

Induction of labor (IOL) is defined as an artificial initiation of uterine contractions before the spontaneous onset of labor.

Augmentation of labor refers to the stimulation of spontaneous but inadequate contractions.

Bishop score is a scoring system which measures changes in the cervix.

It is based on several characteristics such as cervical effacement, dilatation, consistency, position and fetus head station.

Who Took Part

Enrollment: 166 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Multiparous women (women who have given birth one or more times in the past) with a singleton pregnancy that are admitted for induction of labor. Women at gestational age of 370/7 or more.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: age 18 and under; high order gestation; women with contraindication for vaginal delivery.

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.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-04 with completion listed for 2026-04.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The rate of women delivering within 24 hours (time frame: During admission for delivery (assessed up to 5 days since admission to delivery room)).

It also tracked 10 secondary outcomes, for example Length of latent and active phases of labor, The rate of instrumental and caesarean deliveries, chorioamnionitis, obstetric anal sphincter injuries (OASIS), hyponatremia and post-partum hemorrhage (PPH).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 166 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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