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Amr Maneuver for Prevention of Postpartum Hemorrhage
Plain-language guide to NCT04401839: not phased randomized trial of Oxytocin, 306 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04401839
- Phase
- not phased
- Status
- status unknown
- Start
- 2020-05-31
- Completion (planned or actual)
- 2021-08
- 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
The trial (not phased) is built around Oxytocin.
It had two arms (groups): Control group (active comparator) and Study group (active comparator).
The registry classes the interventions as drug and procedure.
More on the Plan
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.
Meanwhile (CCT ) is avoided and watchful waiting for signs of placental separartion till 90 seconds end.
Massage is not employed but the fundus is frequently palpaple to insure it doesnot become atonic and filled with blood from placenta separation.
Who Took Part
306 planned participants were the target.
It was open to women only aged from 18 years up to 45 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Women who candidate for vaginal delivery at casualty department singleton fetus full term pregnancy ( gestational age of more than 37 weeks).
The full record lists 1 inclusion and 1 exclusion criteria.
How the Study Was Run
It was run as a randomized, parallel-group and single-blind study.
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.
In this single-blind Oxytocin study one party knew the assignments and the other did not.
Those kept unaware of assignments: outcomes assessor.
It started in 2020-05-31 with completion listed for 2021-08.
It ran at 1 site in Egypt.
Its stated primary purpose is prevention.
What Was Measured
Primary outcome: 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.