Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage

What Was Tested

This registered not phased trial tested Carbetocin.

The aim of the study is to evaluate the effect of oral tranexamic acid plus, sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH) after vaginal delivery.

It had two arms (groups): TA plus misoprostol (active comparator) and Carbetocin (active comparator).

Patient receive 600mic gm sublingual misoprostol plus oral tranexamic acid 1 gm.

Patient receives 100 mic gm carbetocin IV.

The registry classes the interventions as drug.

More on the Plan

Tranexamic acid (TA) is an antifibrinolytic agent that blocks the lysine-binding site of plasminogen to fibrin.

In previous studies, its safety has been confirmed for use in non-pregnant women, with no thromboembolic complications.

Who Took Part

The registry lists 135 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.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: were gestational age\<37 weeks,; genital tract trauma,; coagulation defect,.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Carbetocin.

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

It started in 2019-04-01 with completion listed for 2021-08-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: the amount of blood loss (time frame: 6 hours post delivery).

It also tracked 2 secondary outcomes, for example need of uterotonics.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carbetocin in 135 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.