Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery

What Was Tested

The trial (not phased) is built around Oxytocin and Carbetocin.

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

The registry classes the interventions as drug.

More on the Plan

Postpartum hemorrhage (PPH) is a potentially life-threatening complication and one of the leading causes of maternal mortality.

Primary PPH is predominantly caused by uterine atony or inadequate contraction of the uterus after childbirth.

Active management of the third stage of labor involves prophylactic administration of a uterotonic agent before delivery of the placenta, as well as delayed cord clamping and controlled traction of the umbilical cord.

Oxytocin, a synthetic pituitary hormone, is the most commonly used first-line uterotonic drug.

Who Took Part

160 planned participants were the target.

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: Overdistended uterus due to:. Polyhydramnios (amniotic fluid index \>24 cm). Fetal macrosomia reported on prenatal ultrasound \>90th centile or \> 4000 gm. Obesity with body mass index (BMI) \>40 kg/m2. Diabetes mellitus on treatment.

The full record lists 9 inclusion and 5 exclusion criteria; among the exclusions: valvular heart disease, arrhythmias, or heart failure; placenta accreta spectrum; bleeding disorder.

How the Study Was Run

The set-up was 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.

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

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, investigator and outcomes assessor.

It started in 2025-01-14 with completion listed for 2026-12.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Proportion of parturients requiring additional uterotonic agents intraoperatively (time frame: 90 minutes).

It also tracked 25 secondary outcomes, for example Uterine Tone 3 minutes, Uterine Tone 5 minutes, Uterine Tone 10 minutes, Calculated blood loss (CBL), Semi-quantitative blood loss (SQBL) and Presence of blood transfusion.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin and Carbetocin in 160 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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