Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening

What Was Tested

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

Twenty-two percent of deliveries in France are induced.

It had two arms (groups): Induction of labor (experimental) and Second cervical ripening (active comparator).

Women randomized in the experimental group will be admitted to the labor ward to undergo induction of labor with intra-veinous oxytocin and early amniotomy. Oxytocin will be administered according to the French guidelines for induction of labor. Maximum oxytocin used should not exceed 10 UI.

The registry classes the interventions as drug.

More on the Plan

In some units, women are admitted into labor ward for induction of labor with oxytocin.

The policy of induction of labor with oxytocin, being the simpler strategy, would be acceptable if it did not lead to a substantially proportion of women with caesarean deliveries compared with a second cervical ripening.

Who Took Part

Enrollment: 1494 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: ≥ 18 years old. With a singleton cephalic pregnancy. ≥37+0 weeks of gestation. Gestational age estimated from the first trimester ultrasound (realized between 11+0 and 13+6 weeks of gestation). Bishop score ≤ 6 at inclusion (unfavorable cervix).

The full record lists 9 inclusion and 10 exclusion criteria; among the exclusions: any measures of legal protection; prior caesarean section or uterine scar; contra-indications to a vaginal delivery.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2021-09-28 with completion listed for 2027-09.

It ran at 14 sites in France (14).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Cesarean delivery rate (time frame: Up to 2 days after intervention).

It also tracked 14 secondary outcomes, for example Time from intervention to delivery in hours, The proportion of women who delivered within 12 hours of the intervention, Maternal satisfaction, assessed with the self administered ACE Questionnaire for Assessing Childbirth Experience (QACE), The proportion of women who require induction with oxytocin (for women in the control group), The indications of caesarean in case of caesarean delivery and The proportion of women with an instrumental delivery.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 1494 people.

With 1494 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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