Prevention of Postpartum Hemorrhage in Patients With Severe Preeclampsia Using Carbetocin Versus Misoprostol

What Was Tested

The trial (phase 3) is built around Carbetocin.

It had two arms (groups): cabetocin (active comparator) and misoprostol (active comparator).

The registry classes the interventions as drug.

More on the Plan

The researchers conducted a prospective non-randomized study at Department of Obstetrics and Gynecology, Benha University Hospital, since March 2013 till June 2015, after approval of the study protocol by the Local Ethical Committee.

A written informed consent was obtained from eligible women before induction or at early stage of labour.

Women with singleton pregnancies of more than 28 weeks' gestation who are admitted to hospital with severe preeclampsia and candidates for vaginal delivery were eligible for the study.

Preeclampsia is labelled as severe in the presence of any of the following abnormalities. 1.

Who Took Part

60 actual participants took part.

It was open to women only aged from 19 years up to 42 years.

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

Examples of who could join: Persistent cerebral or visual disturbances or cerebral edema. Persistent epigastric pain with nausea or vomiting, or both. Systolic ≥160 mmHg or diastolic ≥110 mmHg on 2 occasions at least 6 h apart with the patient at bed rest.

The full record lists 8 inclusion and 1 exclusion criteria; among the exclusions: were hellp syndrome, eclampsia, abruptio placentae, malpresentation, polyhydramnios, previous uterine scar, chorioamnionitis and multiple pregnancies.

How the Study Was Run

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

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

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant.

It started in 2013-03 with completion listed for 2015-08.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

It also tracked 1 secondary outcome, for example measurement of blood loss during second stage of labour.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Carbetocin in 60 people.

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

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