Misoprostol+Oxytocin vs. Carbetocin in CS

Plain-language guide to NCT02786992: phase 2, phase 3 randomized trial of Oxytocin and Carbetocin, 600 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02786992
Phase: phase 2, phase 3
Status: completed
Start: 2016-05
Completion (planned or actual): 2020-01
Participants: 600 (actual)
Design: randomized, quadruple-blind, prevention
Conditions studied: Cesarean Section
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2, phase 3) is built around Oxytocin and Carbetocin.

Patients eligible for elective lower segment cesarean section will be randomized to 2 groups.

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

The registry classes the interventions as drug.

Who Took Part

600 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Women with singleton pregnancy Women scheduled for elective CS full term (gestational age ≥37 weeks).

The full record lists 1 inclusion and 13 exclusion criteria; among the exclusions: hypersensitivity to oxytocin, carbetocin or prostaglandins; contraindication to prostaglandins (e.g. glaucoma); severe asthma.

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.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2016-05 with completion listed for 2020-01.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: incidence of post-partum hemorrhage (time frame: 24 hours). amount of blood loss (time frame: 24 hours).

It also tracked 8 secondary outcomes, for example Number of participants needing hemostatic surgical interventions, Hemoglobin deficit in gm/dl, APGAR score at 1 minute and 5 minutes, Number of participants with NICU admission, Drug side effects and Time till resuming bowel habits.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Oxytocin and Carbetocin in 600 people.

With 600 participants it is a large trial for this field.

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.