Immediate Versus Delayed Induction in Term-PROM Using or Not Antibiotic Prophylaxis

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

The secondary aim is to compare the rates of infection between immediate and delayed induction in women submitted to antibiotic prophylaxis.

It had three arms (groups): Immediate induction with antibiotic prophylaxis (active comparator), Immediate induction without antibiotic prophylaxis (active comparator) and Delayed induction with antibiotic prophylaxis (active comparator).

Immediate induction with antibiotic prophylaxis.

Immediate induction without antibiotic prophylaxis.

Delayed induction (\>= 12 hours after PROM) with antibiotic prophylaxis.

The registry classes the interventions as drug.

Who Took Part

The registry lists 568 planned participants were the target.

It was open to women only.

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

Examples of who could join: Term (≥ 37+0 weeks) singleton pregnancy, a vertex presentation, ruptured membranes for less than 12 hours and a negative Group B Streptococcus (GBS) culture performed between 35 and 37 weeks.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: active labor, absence of gbs culture or indication for gbs antibiotic prophylaxis, contraindication to expectant management or to vaginal delivery.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

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 2013-07 with completion listed for 2018-07.

It ran at 2 sites in Portugal (2).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Maternal and neonatal infection rate (time frame: intrapartum and immediate postpartum).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 568 people.

With 568 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.