High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour in Obese Women

What Was Tested

The trial (phase 4) is built around Oxytocin.

Obesity in pregnancy places women at higher risk of obstetrical complications during pregnancy, delivery and puerperium.

Obesity is a risk factor for cesarean delivery, failed induction of labor and labor dystocia, and prolonged labor curves especially among women with class III obesity.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 202 actual participants took part.

It was open to women only.

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

Examples of who could join: Spontaneous onset of labor. Body mass index ≥ 30 kg/m2. Gestational age ≥ 37 weeks. Reassuring fetal heart rate monitoring. Inefficient uterine contractions during active labor.

The full record lists 8 inclusion and 11 exclusion criteria; among the exclusions: non-reassuring fetal assessment at the time of recruitment; women received cervical ripening agents; any patients contraindicated for vaginal delivery.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant and care provider.

It started in 2018-09-01 with completion listed for 2020-08-31.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: The mean duration from oxytocin augmentation initiation to delivery (time frame: 12 hours).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 202 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.