Bilateral Uterine Artery Ligation in Reducing Incidence of Postpartum Hemorrhage in Cesarean Section

What Was Tested

This registered not phased trial tested Oxytocin.

The patients were recruited from women attending labor ward to undergo cesarean section.

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

Patients at risk of uterine atony undergoing cesarean section underwent bilateral uterine artery ligation and received oxytocin.

Patients at risk of uterine atony undergoing cesarean section received oxytocin only.

The registry classes the interventions as drug and procedure.

Who Took Part

Enrollment: 1070 actual participants took part.

It was open to women only.

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

Examples of who could join: Women with one or more of the following conditions undergoing cesarean section for obstetric indication were included:. Maternal anemia (not less than 7 gm %). Macrosomic baby \>4kgs. Twin pregnancy and high order pregnancy. Previous history of atonic postpartum hemorrhage.

The full record lists 10 inclusion and 4 exclusion criteria; among the exclusions: \- placenta previa; patients with bleeding tendency (congenital or acquired); ante-partum hemorrhage.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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.

The Oxytocin group and the comparison group ran side by side rather than switching.

In this single-blind Oxytocin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2017-12-01 with completion listed for 2018-11-30.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: mean Blood loss after placental separation (time frame: 30 minutes).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 1070 people.

With 1070 participants it is a large trial for this field.

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

More context: the Oxytocin compound page, all human trials.