Carbetocin Versus Misoprostol in Cases With Placenta Previa After C.S.

What Was Tested

The trial (phase 4) is built around Carbetocin.

It had two arms (groups): Pabal ( carbetocin) (active comparator) and Misoprostol (active comparator).

The registry classes the interventions as drug.

More on the Plan

It can result from uterine atony, retained placental tissue including that from abnormal placentation, maternal genital tract trauma and coagulopathies.

(Almog et al, 2011) * Uterotonic agents (e.g. ergometrine, misoprostol) should be easily accessible.

The most common regimen reported for the treatment of post-partum hemorrhage is rectally.

(Oladapo et al., 2012) * Misoprostol is a prostaglandin E1 analogue.

Who Took Part

Enrollment: 200 planned participants were the target.

It was open to women only aged from 25 years up to 40 years.

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

Examples of who could join: Women with a singleton pregnancy undergoing cesarean section after 37 weeks of gestation.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: • women undergoing caesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only; women undergoing caesarean section at less than 37 weeks of gestation; hypertension with pregnancy.

How the Study Was Run

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

Because people in this Carbetocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the participants nor the staff measuring them knew who was on Carbetocin, so expectations could not easily colour the readings.

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

It started in 2014-10 with completion listed for 2021-04.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Uterine tone and size (time frame: One hour after the cesarean section).

It also tracked 1 secondary outcome, for example Blood loss.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Carbetocin in 200 people.

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

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