Open Label Comparative Trial of Dinoprostone Plus or Minus Oxytocin Versus Oxytocin Alone in Cervical Ripening for Labor Induction

What Was Tested

In this phase 4 trial, researchers set out to test Oxytocin.

This is a comparative trial between oxytocin alone and dinoprostone for cervical ripening in unfavorable cervix pregnant women with 38 or more weeks of gestational age.

It had two arms (groups): A (experimental) and B (active comparator).

The registry classes the interventions as drug.

Who Took Part

170 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Gestational age ≥ 38 weeks. Fetal cephalic presentation. Bishop score \< 6.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: no uterine scar (no previous delivery by caesarean section); no more than 3 previous vaginal births; no condition that disallows use of prostaglandins for induction of labor.

How the Study Was Run

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

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 2010-06 with completion listed for 2012-01.

It ran at 4 sites in Brazil (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Vaginal birth delivery within 24 hours and C-section rate (time frame: 24 hours).

It also tracked 3 secondary outcomes, for example Treatment failure rate, Uterine hyperstimulation and/or fetal distress and Use of additional oxytocin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 170 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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