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The Role of Oxytocin in the Second Stage of Labor

Plain-language guide to NCT04303702: not phased randomized trial of Oxytocin, 400 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04303702
Phase
not phased
Status
recruiting participants
Start
2022-07-01
Completion (planned or actual)
2027-06-01
Participants
400 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Labor Complication
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Oxytocin.

This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.

It had two arms (groups): Discontinue Oxytocin (other) and Continue Oxytocin (active comparator).

The registry classes the interventions as drug and other.

More on the Plan

Oxytocin is widely used on Labor and Delivery units throughout the world.Laboring patients are most likely to initiate oxytocin in the first stage of labor.

Among those who receive oxytocin, first stage initiation is far more common than second stage initiation.

These risks call for a closer look at prolonged oxytocin use past the first stage of labor.

Who Took Part

400 planned participants were the target.

It was open to women only.

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

Examples of who could join: Nulliparous pregnant women \>/= 37 weeks gestation. Admission for induction of labor or spontaneous labor.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: multiple gestations; multiparous patients; patients with major fetal anomalies.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2022-07-01 with completion listed for 2027-06-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Second stage duration (time frame: During admission for delivery).

It also tracked 7 secondary outcomes, for example Rate of operative delivery, Rate of Postpartum hemorrhage, Estimated blood loss, Rate of chorioamnionitis during the second stage of labor, Rate of endometritis and Rate of severe perineal laceration.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 400 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.