Oxytocin, Carbetocin and Misopristol for Treatment of Postpartum Hemorrhage: A Multicentric Randomized Trial

What Was Tested

In this not phased trial, researchers set out to test Oxytocin and Carbetocin.

Uterine atony is one of the most important causes of PPH.

The traditional treatment of which is the use of uterotonic agents.

It had three arms (groups): Oxytocin (active comparator), carbetocin (active comparator) and misopristol (active comparator).

The registry classes the interventions as drug.

More on the Plan

All patients with atonic PPH who delivered vaginally will be invited to participate in the study.

Patients who delivered by caesarean section, with retained placenta, with traumatic PPH, associated coagulopathy and those refused to participate in the study will be excluded.

The randomization will be done using opaque sealed envelops containing computer-generated codes.

Written consent will be obtained from all participants and approval from the local institutional ethical committee will be included.

Who Took Part

300 planned participants were the target.

It was open to women only.

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

Examples of who could join: Primary atonic postpartum hemorrhage after vaginal delivery.

The full record lists 1 inclusion and 6 exclusion criteria; among the exclusions: patients who delivered by caesarean section; retained placenta; traumatic postpartum hemorrhage.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

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 2012-09 with completion listed for 2013-06.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: control of postpartum hemorrhage (time frame: within 20 minutes of administration).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin and Carbetocin in 300 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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