Efficacy of Carbetocin in Prevention of Postpartum Hemorrhage in Obese Versus Non Obese Women

What Was Tested

This registered phase 1, phase 2 trial tested Carbetocin.

Postpartum hemorrhage \[PPH\] can have serious consequences and is the leading cause of maternal mortality globally.

Uterine contractility plays an important role in post-delivery uterine involution; impaired contractility can contribute to PPH.

Should contractility be impaired among obese women, there would be implications for management.

It had two arms (groups): Group A: Parturient with BMI ≥ 30 kg/m2. (active comparator) and Group B: Parturients with BMI < 30kg/m2 (control group) (other).

The registry classes the interventions as drug.

More on the Plan

In the United States, the prevalence of maternal obesity has been steadily rising, with more than half of pregnant women classified as overweight or obese.

There are several prophylactic uterotonic agents available for use, including oxytocin, oxytocin/ergometrine, and carbetocin.

Carbetocin is a synthetic analog of oxytocin which provides a longer duration of action than oxytocin (half-life 85-100 min versus 3-4 min).

Also the investigators will examine uterine tone as a surrogate marker for the bioavailability of carbetocin.

Who Took Part

The registry lists 150 actual participants took part.

It was open to women only aged from 18 years up to 39 years.

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

Examples of who could join: Healthy women with a singleton pregnancy undergoing a Cesarean delivery after at least 37 completed weeks of gestation under regional anesthesia. Aged (18-39) years and with signed informed consent.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: emergency cesarean section due to fetal distress; maternal comorbidities such as severe cardiovascular disorders, kidney or liver disorders, coagulopathies, as well as epilepsy; uterine malformation.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Carbetocin study: the participants and staff both knew the treatment.

It started in 2023-07-06 with completion listed for 2023-10-25.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Estimated Blood loss (ml) at cesarean section (time frame: 3 months).

It also tracked 2 secondary outcomes, for example Estimated Blood loss by weighing gauze towel.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Carbetocin in 150 people.

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

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