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Carbetocin Versus Oxytocin and Ergometrine for the Prevention of Postpartum Haemorrhage Following Caesarean Section
Plain-language guide to NCT02101567: phase 4 randomized trial of Oxytocin and Carbetocin, anemia, 200 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02101567
- Phase
- phase 4
- Status
- completed
- Start
- 2014-05
- Completion (planned or actual)
- 2015-04
- Participants
- 200 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Bleeding; Anemia
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Oxytocin and Carbetocin for anemia.
It had two arms (groups): Pabal ( carbetocin) (active comparator) and Oxytocin and Methergine (methyl ergometrine) (active comparator).
The registry classes the interventions as drug.
More on the Plan
The study population will include 200 patients.
Who Took Part
Enrollment: 200 actual participants took part.
It was open to women only aged from 20 years up to 30 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: • Women with a singleton pregnancy undergoing elective cesarean section after 37 weeks of gestation.
The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only; women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies); hypertension with pregnancy.
How the Study Was Run
Design: randomized, parallel-group and quadruple-blind.
Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.
The Oxytocin group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the anemia participants and researchers unaware of who received Oxytocin.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2014-05 with completion listed for 2015-04.
It ran at 1 site in Egypt.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Uterine tone and size (time frame: One hour after the cesarean section).
It also tracked 1 secondary outcome, for example Blood loss.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Oxytocin and Carbetocin in 200 people with anemia.
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, Anemia research.
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.