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Effect of Co-administration of Carbetocin and Calcium Chloride on Uterine Tone in Patients Undergoing Elective Cesarean Delivery
Plain-language guide to NCT07187544: not phased randomized trial of Carbetocin, 120 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07187544
- Phase
- not phased
- Status
- recruiting participants
- Start
- 2025-12-01
- Completion (planned or actual)
- 2026-12
- Participants
- 120 (estimated)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Postpartum Hemorrhage (Primary)
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Carbetocin.
It had two arms (groups): Calcium (active comparator) and Placebo (placebo comparator).
The registry classes the interventions as drug and other.
Who Took Part
The registry lists 120 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: Scheduled CD for patients ≥ 37 weeks excluding high risk factors for uterine atony. Neuraxial anesthesia as the primary anesthetic where intrathecal medications are the primary anesthetic.
The full record lists 2 inclusion and 13 exclusion criteria; among the exclusions: risk factors for uterine atony including:; obesity with body mass index (bmi) \> 40 kg/m2; placenta previa and/or placenta accreta.
How the Study Was Run
It was run as a randomized, parallel-group and quadruple-blind study.
The participants were allocated by chance, so the Carbetocin group and the comparison group should start out alike.
The Carbetocin group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Carbetocin, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2025-12-01 with completion listed for 2026-12.
It ran at 1 site in Canada.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Uterine Tone 10 minutes (time frame: 10 minutes).
It also tracked 22 secondary outcomes, for example Uterine Tone baseline, Uterine Tone 5 minutes, Uterine Tone 15 minutes, Uterine Tone 20 minutes, Additional uterotonic agents required intraoperatively and Additional uterotonic agents required post-operatively.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Carbetocin in 120 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Carbetocin compound page, all human trials.
Our Notes on the Compound
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.