Comparison Of The Effects Of Carbetocin And Oxytocin In C-Sectıon

Plain-language guide to NCT05742854: phase 4 randomized trial of Oxytocin and Carbetocin, 200 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT05742854
Phase: phase 4
Status: status unknown
Start: 2023-03-09
Completion (planned or actual): 2023-05-31
Participants: 200 (estimated)
Design: randomized, open label (everyone knows who gets what), prevention
Conditions studied: Carbetocin; Oxytocic Drugs Causing Adverse Effects in Therapeutic Use
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around Oxytocin and Carbetocin.

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

The registry classes the interventions as drug and procedure.

Who Took Part

200 planned participants were the target.

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

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

Examples of who could join: 18-45 years old. Pregnant women to have a C-section,. Subjects with no history of oxytocin allergy, At term, no multiple pregnancies, elective C-section.

The full record lists 3 inclusion and 1 exclusion criteria; among the exclusions: subjects with a history of oxytocin allergy, subjects scheduled for an emergency c-section, multiple pregnancies, having been diagnosed with diabetes mellitus.

How the Study Was Run

Design: randomized, crossover and open-label.

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

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-03-09 with completion listed for 2023-05-31.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Effect of uterotonic agents on uterine tone (time frame: intraoperative). hemorrhage (time frame: haemoglobin levels before and after 6 hours).

It also tracked 2 secondary outcomes, for example in terms of haemodynamic changes uterotonic agents cause and side effects of uterotonic agents.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin and Carbetocin in 200 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.