Bilateral Uterine Artery Ligation During the Cesarean Delivery of Twins

What Was Tested

The trial (not phased) is built around Oxytocin.

It had two arms (groups): study group (experimental) and control group (active comparator).

Patients with twin pregnancy undergoing cesarean section underwent bilateral uterine artery ligation and received oxytocin.

Patients with twin pregnancy undergoing cesarean section received oxytocin only.

The registry classes the interventions as drug and procedure.

More on the Plan

Women with twin pregnancy undergoing scheduled or emergency cesarean were randomized into two groups.

In the BUAL group, women underwent BUAL before placental delivery; in the control group, women had cesarean delivery without BUAL.

The primary outcome was the estimated blood loss during a cesarean.

Who Took Part

Enrollment: 400 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Women undergoing cesarean section.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: placenta previa; ante-partum hemorrhage; patient refuse to participate.

How the Study Was Run

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

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2020-09-01 with completion listed for 2022-06-30.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): mean Blood loss after placental separation (time frame: 30 minutes).

It also tracked 2 secondary outcomes, for example Number of Participants with postpartum hemorrhage and The number of participant needed for blood transfusion.

What This Means in Plain Language

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