Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous or Induced Labour

What Was Tested

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

It had two arms (groups): Experimental group (experimental) and Control group (active comparator).

The experimental group will receive oxytocin at 4 mIU/mL.

The control group will receive oxytocin at 2 mIU/mL.

The registry classes the interventions as drug.

More on the Plan

The research is a double-blind controlled trial, including primiparous obese women in spontaneous or induced labour, for whom a prescription of oxytocin is decided.

Who Took Part

The registry lists 443 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: Age ≥ 18 years. Nulliparous (no previous childbirth beyond 22 SA). BMI ≥ 30 kg/m² at the beginning of pregnancy. Spontaneous or induced onset of labour. Term ≥ 37 weeks of gestation and \< 42 weeks of gestation.

The full record lists 10 inclusion and 11 exclusion criteria; among the exclusions: hypersensitivity to the active substance (oxytocin), to any of its excipients or to latex (risk of cross allergy); medical contraindication for oxytocin; coagulation disorders.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind 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.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-10-02 with completion listed for 2024-12-30.

It ran at 12 sites in France (12).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Rate of caesarean section during labour (time frame: through study completion, an average of 1 month).

It also tracked 12 secondary outcomes, for example Length of labour phases, Arrest of labour, Interruption of oxytocin perfusion and causes, Uterine hyper-stimulation, Mode of vaginal delivery and Reason for the caesarean section.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 443 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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