← Human Trials & Peer-Reviewed Studies
Carbetocin vs Misoprostol for Postpartum Hemorrhage Prevention
Plain-language guide to NCT07353281: not phased randomized trial of Carbetocin, 146 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07353281
- Phase
- not phased
- Status
- not yet recruiting
- Start
- 2026-01-31
- Completion (planned or actual)
- 2028-01-01
- Participants
- 146 (estimated)
- Design
- randomized, open label (everyone knows who gets what), prevention
- Conditions studied
- Postpartum Complication; Postpartum Hemorrhage
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Carbetocin.
Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide, particularly among women with known risk factors.
Carbetocin, a long-acting oxytocin analogue, and misoprostol are both used for this purpose, but comparative data in high-risk vaginal deliveries remain limited.
It had two arms (groups): Carbetocin arm (experimental) and Misoprostol arm (active comparator).
The registry classes the interventions as drug.
More on the Plan
Postpartum hemorrhage (PPH), most commonly caused by uterine atony, remains a major contributor to maternal morbidity and mortality.
This prospective, randomized, single-center study will enroll women at term with singleton pregnancies and predefined risk factors for postpartum hemorrhage.
The primary outcome is the occurrence of postpartum hemorrhage.
Who Took Part
146 planned participants were the target.
It was open to women only aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Women aged 18 years or older. Gestational age 37-42 weeks. Presence of one or more risk factors for postpartum hemorrhage, including:. Grand multiparity (≥5 previous deliveries). History of postpartum hemorrhage.
The full record lists 15 inclusion and 8 exclusion criteria; among the exclusions: multiple gestation; known major fetal anomalies; intrauterine fetal demise (iufd).
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Because people in this Carbetocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Carbetocin group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Carbetocin study: the participants and staff both knew the treatment.
It started in 2026-01-31 with completion listed for 2028-01-01.
Its stated primary purpose is prevention.
What Was Measured
Primary outcome: Postpartum hemorrhage (PPH) (time frame: Within 24 hours after delivery). Need for additional uterotonic treatment or surgical intervention (time frame: Within 24 hours of delivery).
It also tracked 3 secondary outcomes, for example Change in hemoglobin level, Blood transfusion requirement and Maternal adverse effects related to study medications.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Carbetocin in 146 people.
Its status is not yet 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.