The Comparison of the Effect of Different Oxytocin Administrations on the Blood Loss During Cesarean Delivery

Plain-language guide to NCT03967171: not phased randomized trial of Oxytocin, post-surgical inflammation and surgery recovery, 101 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT03967171
Phase: not phased
Status: completed
Start: 2019-05-01
Completion (planned or actual): 2019-06-20
Participants: 101 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Cesarean Section Complications; Postpartum Hemorrhage; Blood Loss, Surgical; Blood Loss, Postoperative; Postoperative Pain; Atony, Uterine
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Oxytocin for post-surgical inflammation and surgery recovery.

This study compares the effect of starting intravenous oxytocin infusion early before uterine incision versus late after umbilical cord clamping on the blood loss during elective cesarean section.

It had two arms (groups): before uterine incision oxytocin group (experimental) and after clamping the umbilical cord oxytocin group (active comparator).

The registry classes the interventions as other.

More on the Plan

Several regimens of oxytocin have been tested during cesarean section with variable wanted (uterotonic) and unwanted (cardiovascular) effects.

Who Took Part

Enrollment: 101 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Single fetus at term \>37 weeks of gestational age.

The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: history of previous cesarean section; history of previous uterine surgery; multiple gestation, placenta previa, polyhydramnious, fetal macrosomia.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The post-surgical inflammation and surgery recovery participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Groups ran in parallel: each of the post-surgical inflammation and surgery recovery participants stayed in one arm throughout.

Being open-label, the Oxytocin study did not mask who received what.

It started in 2019-05-01 with completion listed for 2019-06-20.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: blood loss during elective cesarean section (time frame: 2 hours).

It also tracked 1 secondary outcome, for example postoperative blood loss.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 101 people with post-surgical inflammation and surgery recovery.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, Post-surgical inflammation and surgery recovery research.

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.

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.