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Cervical Traction vs. Active Management of 3rd Stage of Labor

Plain-language guide to NCT04747015: not phased randomized trial of Oxytocin, 306 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04747015
Phase
not phased
Status
status unknown
Start
2020-07-13
Completion (planned or actual)
2021-12
Participants
306 (estimated)
Design
randomized, single-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.

In the maneuver,sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds.

The traction should be adequate to allow the cervix to reach the vaginal introitus.

It had two arms (groups): Cervical traction (active comparator) and Active management (active comparator).

Sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds. The traction should be adequate to allow the cervix to reach the vaginal introitus.

The registry classes the interventions as drug and procedure.

Who Took Part

Enrollment: 306 planned participants were the target.

It was open to women only aged from 18 years up to 42 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 0 inclusion and 1 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

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.

Only one side, usually the participants, was kept unaware of whether Oxytocin was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2020-07-13 with completion listed for 2021-12.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: occurrence of postpartum hemorrhage (time frame: 24 hours after delivery).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 306 people.

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.