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Oxytocin Maintenance Infusion in Labouring Women Undergoing Cesarean Delivery: an Up-down Sequential Allocation Study

Plain-language guide to NCT05290129: not phased non-randomized trial of Oxytocin, 40 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05290129
Phase
not phased
Status
recruiting participants
Start
2022-08-17
Completion (planned or actual)
2026-12
Participants
40 (estimated)
Design
non-randomized, quadruple-blind, treatment
Conditions studied
Postpartum Hemorrhage
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Oxytocin.

Oxytocin is a drug that is routinely used to help the uterus to contract and keep it contracted after delivery.

It had ten arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 40 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

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

The full record lists 0 inclusion and 6 exclusion criteria; among the exclusions: all patients who refuse to give written informed consent; all patients who declare allergy or hypersensitivity to oxytocin; A history of hypertension and/or severe cardiac disease(s).

How the Study Was Run

Design: non-randomized, parallel-group and quadruple-blind.

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 2022-08-17 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 up to discharge from the post anesthetic care unit (PACU): questionnaire (time frame: 2 hours).

It also tracked 18 secondary outcomes, for example Calculated blood loss, Need for blood transfusion, Episodes of bleeding postpartum, Intraoperative requirement for additional uterotonic medication, Requirement for additional uterotonic medication in the PACU and Requirement for additional uterotonic medication from discharge from the PACU until 24 hours postpartum.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Oxytocin in 40 people.

It is still recruiting; 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.