Intra-myometrial Vasopressin During Cesarean Section in Placenta Previa

What Was Tested

This registered not phased trial tested Vasopressin.

It had two arms (groups): Intramyometrial Vasopressin (experimental) and Placebo (placebo comparator).

The placebo group received a 10-mL bolus injection of saline into the myometrium during slow (30-seconds)immediately after delivery, as soon as the umbilical cord was clamped.

The registry classes the interventions as drug.

More on the Plan

The study drug was administered immediately after delivery, as soon as the umbilical cord was clamped.

Who Took Part

120 actual participants took part.

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.

The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: patients with a cardiac, hepatic, renal or thromboembolic disease; patients with the high possibility of the morbid adherent placenta; known coagulopathy.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Vasopressin and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Vasopressin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2018-12-01 with completion listed for 2021-06-30.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Number of Participants with postpartum hemorrhage (time frame: 6 hours post operative).

It also tracked 3 secondary outcomes, for example intraoperative blood loss, The number of participant needed for blood transfusion and need of extra surgical maneuvers.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vasopressin in 120 people.

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

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