Carbetocin Versus Oxytocin for Prevention of Postcesarean Hemorrhage in Pregnancy With High Risk for PPH

Plain-language guide to NCT04089176: early phase 1 randomized trial of Oxytocin and Carbetocin, 120 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT04089176
Phase: early phase 1
Status: completed
Start: 2019-02-01
Completion (planned or actual): 2019-04-30
Participants: 120 (actual)
Design: randomized, double-blind, treatment
Conditions studied: Postpartum Hemorrhage; Cesarean Section; High Risk Pregnancy
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this early phase 1 trial, researchers set out to test Oxytocin and Carbetocin.

It had two arms (groups): protocal A (active comparator) and protocal B (active comparator).

Carbetocin versus placebo.

Oxytocin versus placebo.

The registry classes the interventions as drug.

More on the Plan

Defined patient in two group.

Primary outcome is evaluate additional drug use Secondary outcome is evaluated estimated blood loss, hemoglobin level.

Who Took Part

120 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Previous history of postpartum hemorrhage. Previous cesarean section. Prolonged premature rupture of membrane. Augmentation of labour.

The full record lists 9 inclusion and 3 exclusion criteria; among the exclusions: pregnancy induce hypertension; on anticoagulant; placenta previa or placenta percreta.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and care provider.

It started in 2019-02-01 with completion listed for 2019-04-30.

It ran at 1 site in Thailand.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Additional drug use (time frame: during intra-operation).

It also tracked 3 secondary outcomes, for example Estimate blood loss, Side effect and Hemoglobin level.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Oxytocin and Carbetocin in 120 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 and the Carbetocin compound page, all human trials.

Our Notes on the Compounds

Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.

Carbetocin: A long-acting oxytocin analog used outside the US to prevent bleeding after childbirth; also studied intranasally in Prader-Willi syndrome.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.