Tearing of Membranes Before Birth - a Comparison Between Two Ways of Induction of Labor Pitocin Opposite Prostaglandin

What Was Tested

This registered phase 3 trial tested Oxytocin.

Since the duration until delivery is important in avoiding the risk of complications, several studies have been performed in order to understand what is the preferred way to manage this condition of PROM in women that are not in active labor.

In the largest random study that has been performed 20 years ago, there was found an advantage for labor induction with oxytocin over labor induction with Prostaglandin or waiting.

It had two arms (groups): Intravenous oxytocin (experimental) and vaginal prostaglandin (experimental).

The registry classes the interventions as drug.

More on the Plan

Therefore, the aim of the study is to compare randomly the perinatal outcomes in women with PROM and low BISHOP between women who undergo labor induction with Oxytocin and women who undergo labor induction with Prostaglandin E2.

Who Took Part

Enrollment: 1200 planned participants were the target.

It was open to women only aged from 18 years up to 42 years.

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

Examples of who could join: Rupture of membranes in BISHOP score lower than 7. Pregnancy week 34+0 and onward. Verifying fetal monitoring. Normal maternal temperature (lower than 37.8). Without vaginal bleeding or suspected placental separation.

The full record lists 8 inclusion and 5 exclusion criteria; among the exclusions: multiple pregnancy; maternal age below 18 or over 42; active labor.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.

It started in 2016-05 with completion listed for 2019-05.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The duration from the beginning of labor induction until delivery (time frame: 5 days).

It also tracked 1 secondary outcome, for example Duration of labor induction from rupture of membranes until delivery.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 1200 people.

With 1200 participants it is a large trial for this field.

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.