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Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section
Plain-language guide to NCT02079558: phase 2 randomized trial of Oxytocin and Carbetocin, 220 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02079558
- Phase
- phase 2
- Status
- completed
- Start
- 2012-09
- Completion (planned or actual)
- 2013-09
- Participants
- 220 (actual)
- Design
- randomized, double-blind, screening
- Conditions studied
- Postpartum Hemorrhage
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Oxytocin and Carbetocin.
Postpartum hemorrhage (PPH) is a common complication of childbirth and a leading cause of maternal morbidity and mortality.
It had two arms (groups): Oxytocin (experimental) and Carbetocin (experimental).
The registry classes the interventions as drug.
Who Took Part
220 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: At least one risk for postpartum hemorrhage and lack of hypersensitivity to oxytocin and carbetocin.
The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: patients' refusal to cooperate, major therapeutic side effects, history of cardiac and renal disease or preeclampsia.
How the Study Was Run
The set-up was randomized, parallel-group and double-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.
As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2012-09 with completion listed for 2013-09.
It ran at 1 site in Iran.
Its stated primary purpose is screening.
What Was Measured
Researchers chose this as the main measure: screening of Cessation of bleeding (time frame: screening until 24 hours after placenta disconnection). time duration to stop bleeding in the case of post-cesarean section (time frame: 24 hours).
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Oxytocin and Carbetocin in 220 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.