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Comparison of the Effect of Carbetocin Versus Oxytocin in the Prevention of Postpartum Hemorrhage After Emergency Caesarean Section in Antenatal Low-risk Patients

Plain-language guide to NCT07380529: not phased randomized trial of Oxytocin and Carbetocin, 300 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07380529
Phase
not phased
Status
completed
Start
2024-10-01
Completion (planned or actual)
2025-08-04
Participants
300 (actual)
Design
randomized, triple-blind, prevention
Conditions studied
Postpartum Hemorrhage \(PPH\)
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Oxytocin and Carbetocin.

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

Standard oxytocin regimen after delivery (uterotonic prophylaxis at emergency cesarean).

The registry classes the interventions as drug.

More on the Plan

The secondary aim is to observe the changes in intraoperative and postoperative hemodynamic parameters after the administration of these two drugs.

According to NICE (National Institute Health and Care) and RCOG (Royal College of Obstetricians and Gynaecologists) guidelines, patients who are in the emergency caesarean category 1 (The life of the mother or baby is in danger.

The caesarean should be performed as soon as possible, usually within 30 minutes after the decision is made) group will be included.

The secondary aim is to observe the changes in intraoperative and postoperative hemodynamic parameters after the administration of these two drugs.

Who Took Part

The registry lists 300 actual participants took part.

It was open to women only.

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

Examples of who could join: Term pregnancy (\>37 weeks gestation). Not having had a cesarean section before. Emergency cesarean delivery (category 1). Low risk for postpartum hemorrhage. Vaginal labor has started (\> 4 cm cervical dilatation) or a decision has been made (rupture of membranes, Abnormal findings on NST or other signs of fetal compromise.).

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: non-term pregnancy (\< 37 weeks gestation); non- vertex presentation; antenatal high risk pregnancy for postpartum hemorrhage (preeclampsia/eclampsia, previous uterine surgery, placental anomalies).

How the Study Was Run

Design: randomized, parallel-group and triple-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 and outcomes assessor.

It started in 2024-10-01 with completion listed for 2025-08-04.

It ran at 2 sites in Turkey (Türkiye) (2).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Postoperative change in hemoglobin at 24 hours (time frame: Baseline (preoperative) and within 24 hours after emergency cesarean delivery).

It also tracked 2 secondary outcomes, for example Need for additional uterotonic agents and Postoperative change in hematocrit at 24 hours.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin and Carbetocin in 300 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.

Related Pages

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.