Tranexamic Acid Plus Buccal Misoprostol on Blood Loss During and After Cesarean Delivery

What Was Tested

This registered not phased trial tested Oxytocin.

The risk of PPH is much higher for women undergoing cesarean delivery (CD).

In the majority of cases, uterine atony is responsible for the occurrence of excessive bleeding during or following childbirth.

It had two arms (groups): oxytocin (active comparator) and Tranexamic acid plus misoprostol (active comparator).

The registry classes the interventions as drug.

More on the Plan

The misoprostol and placebo tablets were similar in size, shape, and color, and ampoules of oxytocin will be also similar to placebo.

Randomization was done by the investigator immediately before transfer to the theater, whereas the preparation of packets and confidential record maintenance was done by the labor room nursing staff.

Who Took Part

Enrollment: 400 actual participants took part.

It was open to women only aged from 20 years up to 45 years.

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

Examples of who could join: Patients scheduled for an elective cesarean section with risk factors for atonic PPH.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: patients with a cardiac, hepatic, renal or thromboembolic disease; patients had an allergy to tranexamic acid; suspected coagulopathy.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

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

It started in 2018-11-01 with completion listed for 2020-03-31.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

It also tracked 3 secondary outcomes, for example difference between preoperative and postoperative hemoglobin, intraoperative blood loss and post operative blood loss.

What This Means in Plain Language

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

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.