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High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth
Plain-language guide to NCT06550089: phase 2 randomized trial of Oxytocin. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06550089
- Phase
- phase 2
- Status
- withdrawn
- Start
- 2024-10
- Completion (planned or actual)
- 2026-10
- Participants
- n/a (actual)
- Design
- randomized, open label (everyone knows who gets what), prevention
- Conditions studied
- Postpartum Hemorrhage; Pregnancy Complications; Cesarean Section Complications
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Oxytocin.
Further the investigators, aim to assess whether there are differences in health outcomes between both arms of the study.
It had two arms (groups): one (experimental) and one (active comparator).
The registry classes the interventions as drug.
More on the Plan
Who Took Part
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: Age 18 or greater. English or Spanish speaking. Individuals undergoing a scheduled or unscheduled cesarean delivery.
The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: patient on therapeutic anticoagulation; patient with hypertensive disorder of pregnancy or chronic hypertension; patient with preexisting bleeding disorder.
How the Study Was Run
Design: randomized, parallel-group and open-label.
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.
Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.
It started in 2024-10 with completion listed for 2026-10.
Its stated primary purpose is prevention.
What Was Measured
Researchers chose this as the main measure: Screen failure rate (time frame: Within 8 hours prior to cesarean delivery). Fidelity rate (time frame: Within 8 hours prior to cesarean delivery). Trial retention rate (time frame: Up to 6 weeks after cesarean delivery).
It also tracked 14 secondary outcomes, for example Maternal flushing, Maternal hypotension, Maternal nausea/vomiting, Myocardial ischemia, Cardiac arrhythmia and Quantitative blood loss greater than 1 liter.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Oxytocin in people.
It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Oxytocin compound page, all human trials.
Our Notes on the Compound
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
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.