Carbetocin Versus Oxytocin for Prophylaxis Against Atonic Primary Post-partum Hemorrhage

Plain-language guide to NCT05479357: not phased randomized trial of Oxytocin and Carbetocin, 80 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT05479357
Phase: not phased
Status: status unknown
Start: 2022-07-28
Completion (planned or actual): 2022-12-30
Participants: 80 (estimated)
Design: randomized, single-blind, prevention
Conditions studied: Atonic Postpartum Hemorrhage; High Risk Pregnancy
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Oxytocin and Carbetocin.

Comparison between Carbetocin and Oxytocin as prophylaxis against Primary Postpartum Hemorrhage.

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

The registry classes the interventions as drug.

More on the Plan

The trial will be conducted on patients with high risk of developing atonic primary postpartum hemorrhage.

The trial will be single blinded.

All patients fulfilling the inclusion criteria undergoing elective Caesarean section will be approached by the treating physician and will be asked to participate in the study.

An informed written consent will be taken from each patient.

Who Took Part

80 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: History of postpartum hemorrhage. Interstitial or submucous fibroid. (Single larger than 4 cm or Multiple myomata).

The full record lists 8 inclusion and 5 exclusion criteria; among the exclusions: • patients without high risk for post-partum hemorrhage; patients at high risk for postpartum hemorrhage but will deliver vaginally; patients with medical disorders complicating pregnancy.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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

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

In this single-blind Oxytocin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2022-07-28 with completion listed for 2022-12-30.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Amount of Postpartum Hemorrhage (time frame: First 24 hours after Delivery).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin and Carbetocin in 80 people.

Its status is unknown; 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.