A Pilot Study: High Versus Low Oxytocin Dosing for Induction of Labor in Pregnant Patients With Obesity

What Was Tested

The trial (phase 4) is built around Oxytocin.

Pregnant patients with obesity are more likely to undergo induction of labor and have a higher risk of failed induction compared to patients with normal weight.

The association between maternal obesity and labor dysfunction leading to cesarean delivery is poorly understood.

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

The registry classes the interventions as drug.

More on the Plan

This study is a pragmatic single center randomized, double blinded controlled trial.

Nulliparous women with a pre-pregnancy body mass index (BMI) ≥30 kg/m2 undergoing induction of labor at ≥37 weeks' gestation will be eligible for enrollment.

All other aspects of obstetric management will be at the discretion of the patient's clinical care team.

Postpartum maternal, neonatal, and delivery outcomes will be collected.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Maternal age \>18 years. Gestational age ≥37w0d. Indication for oxytocin use in the first stage of labor. No contraindication to labor or vaginal delivery. Pre-pregnancy BMI ≥30 kg/m2 based on patient report and confirmed by pre-pregnancy or first trimester weight as recorded in the medical record.

The full record lists 10 inclusion and 16 exclusion criteria; among the exclusions: fetal demise; major fetal congenital malformation or known chromosomal abnormality; prior uterine surgery (e.g., cesarean, myomectomy).

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2022-04-06 with completion listed for 2022-09-18.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants Delivered by Cesarean (time frame: Until delivery).

It also tracked 16 secondary outcomes, for example Duration of Time From Start of Induction to Delivery, Duration of the First Stage of Labor, Occurrence of Tachysystole, Incidence of Uterine Rupture, Incidence of Clinical Chorioamnionitis and Incidence of Postpartum Maternal Infectious Morbidity.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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