Stepwise Labor Induction Following Failure of Prostaglandin Vaginal Insert for Labor Induction

What Was Tested

In this phase 3 trial, researchers set out to test Oxytocin.

During the past years there has been an additional rise due to elective inductions 2.

It had two arms (groups): Administration of Propess (experimental) and Intravenous oxytocin infusion + balloon (experimental).

The registry classes the interventions as device and drug.

Who Took Part

Enrollment: 320 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: Maternal age of 18 years or greater. Bishop score of 7 or less 24 hours after the insertion of Propess. Pregnancies at 36+0/7 weeks of gestation and beyond. Normal fetal heart rate tracings and normal sonogram at admission (ie Vertex, appropriate for gestational age, biophysical score of 8/8, normal amniotic fluid index). No contraindication for prolongation of pregnancy (e.g. intrauterine infection, placental abruption, etc.).

The full record lists 6 inclusion and 2 exclusion criteria; among the exclusions: rupture of membranes (rom) after initial propess insertion.

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.

The Oxytocin group and the comparison group ran side by side rather than switching.

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

It started in 2016-04 with completion listed for 2018-04.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time from second agent induction to delivery (time frame: 48 hours).

It also tracked 3 secondary outcomes, for example Rate of failed induction defined as 5 cm dilatation, Rate of failed induction defined as regular contractions and cesarean sections rate.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 320 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.