Carbetocin Versus Oral Tranexamic Acid Plus, Buccal Misoprostol on Blood Loss After Vaginal Delivery

What Was Tested

This registered not phased trial tested Carbetocin.

It had three arms (groups): carbetocin (active comparator), Tranexamic acid plus misoprostol (experimental) and misoprostol (active comparator).

The registry classes the interventions as drug.

More on the Plan

All women admitted to the reception unit for vaginal delivery were invited to participate in the study.

The investigators included women aged (20-35 years) with a singleton pregnancy in a cephalic presentation between 38 and 42 weeks gestation.

The participated women have entered the screening phase of the study.

This phase included history taking (age, parity, and gestational age) with measurement of weight, temperature, and initial hemoglobin level.

Who Took Part

The registry lists 360 actual participants took part.

It was open to women only aged from 20 years up to 40 years.

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

Examples of who could join: All women admitted to the reception unit for vaginal delivery. Women aged (20-35 years) with a singleton pregnancy in a cephalic presentation between 38 and 42 weeks gestation.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: medical disorders such as cardiac, hepatic, renal, neurologic disorders thromboembolic disease, blood disorders, diabetes, gestational hypertension, and pre-eclampsia; women at risk for pph as grand multipara (parity \>5), multiple pregnancies, polyhydramnios, fetal macrosomia, antepartum hemorrhage, prolonged, and obstructed labor were also excluded.-; moreover, we excluded women with a scarred uterus or previous instrumental delivery and those suffering from hypersensitivity to ta.

How the Study Was Run

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

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

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

Being open-label, the Carbetocin study did not mask who received what.

It started in 2018-12-01 with completion listed for 2020-05-31.

It ran at 2 sites in Egypt (2).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: difference in the mean blood loss at 4 h postpartum between the three groups (time frame: 4 hours post delivery).

It also tracked 2 secondary outcomes, for example difference in hemoglobin level and the need for additional uterotonics.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carbetocin in 360 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.