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Standard Oxytocin Versus High Dose Oxytocin to Control Postpartum Hemorrhage in High Risk Pregnancy During Elective Cesarean Section

Plain-language guide to NCT06560099: not phased randomized trial of Oxytocin, 39 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06560099
Phase
not phased
Status
status unknown
Start
2024-08-25
Completion (planned or actual)
2025-04-25
Participants
39 (estimated)
Design
randomized, quadruple-blind, prevention
Conditions studied
Post Partum Hemorrhage
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

It had two arms (groups): one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 39 planned participants were the target.

It was open to women only aged from 20 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: \- Medical disorders ie: Hypertensive diseases with pregnancy - Diabetes Mellitus - Collagen diseases - Coagulopathies - Cardiac diseases - Anemia. History of postpartum hemorrhage. Placental disorders ie: placenta previa. Infertility and ICSI. History of Endometriosis.

The full record lists 11 inclusion and 5 exclusion criteria; among the exclusions: \- oxytocin allergy; normal uncomplicated pregnancy; emergency cesarean section.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-08-25 with completion listed for 2025-04-25.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): blood loss (time frame: at the end of the operation).

It also tracked 2 secondary outcomes, for example haemoglobin and haemoglobin.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 39 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; 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.