Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With BMI ≥ 40kg/m2

What Was Tested

The trial (not phased) is built around Oxytocin.

Postpartum hemorrhage (PPH) due to uterine atony is a major cause of maternal morbidity and mortality.

It had six arms (groups): one (active comparator), one (active comparator), one (active comparator), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

Laboratory studies show that BMI alone appears to contribute to blunted uterine muscle responses and therefore contraction responses to oxytocin in obese women.

Who Took Part

The registry lists 30 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Elective cesarean delivery under regional anesthesia. Gestational age ≥ 37 weeks. No known additional risk factors for postpartum hemorrhage. Written informed consent to participate in this study.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: refusal to give written informed consent; allergy or hypersensitivity to oxytocin; hepatic, renal, and vascular disease.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

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

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

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

It started in 2019-06-26 with completion listed for 2020-02-03.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Uterine tone 2 minutes: questionnaire (time frame: 2 minutes).

It also tracked 16 secondary outcomes, for example Need for uterine massage: questionnaire, Intraoperative requirement for additional uterotonic medication, Calculated estimate of blood loss, Intravenous fluid administered during surgery, Presence of ventricular tachycardia: ECG and Presence of atrial fibrillation: ECG.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 30 people.

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

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.