Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid During Cesarean Section

What Was Tested

The trial (not phased) is built around Oxytocin and Carbetocin.

It had three arms (groups): Carbetocin plus placebo to TA and placebo to oxytocin (active comparator), oxytocin plus TA (active comparator) and oxytocin plus placebo to TA and placebo to carbetocin (active comparator).

The registry classes the interventions as drug.

More on the Plan

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

Oxytocin is regarded as the gold standard uterotonic agent but only has a half-life of 4-10 min; therefore, at cesarean section oxytocin must be administered as a continuous intravenous infusion to attain sustained uterotonic activity throughout the surgical procedure and immediate postpartum period.

A single intravenous bolus of carbetocin produces a tetanic uterine contraction within 2 min and persists for an average of 60 min following injection.

Who Took Part

400 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Women who undergo elective cesarean section with one or more risk factors for PPH were the candidates for participation. With fetal macrosomia, polyhydramnios, low insertion of the placenta, multiple gestations, prolonged labor, chorioamnionitis, past history of PPH, diabetes and high parity (5 previous deliveries).

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: suspected coagulopathy,; history of coronary artery disease or hypertension,; women with a history of hypersensitivity to carbetocin, ta or oxytocin.

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 Oxytocin and who got the comparison, which limits bias.

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2019-01-01 with completion listed for 2021-03-30.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

It also tracked 3 secondary outcomes, for example estimation of intraoperative blood loss (ml), amount of postoperative blood loss and number of patient with postpartum hemorrhage.

What This Means in Plain Language

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