Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony, During Elective Cesarean Section

What Was Tested

The trial (phase 4) is built around Carbetocin.

It had two arms (groups): one (active comparator) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Postpartum hemorrhage is a major cause of mortality and morbidity in the world, and it is most often caused by uterine atony.

Carbetocin, a long-acting synthetic analogue of oxytocin, has been used for this purpose for many years.

This medication has numerous side effects: hypotension, tachycardia, nausea, vomiting, chest pain, etc.

Who Took Part

72 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: ≥ 18 years old. ≥ 37-week pregnancy. Elective cesarean section with a low transverse incision. ASA I or II.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: personal history of uterine atony or postpartum hemorrhage; abnormal placental implantation (known or suspected); \> 3 cesarean sections in the past.

How the Study Was Run

Design: 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.

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, investigator and outcomes assessor.

It started in 2012-04 with completion listed for 2012-07.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Utilization of a second uterotonic drug (time frame: First 48 hours of the postpartum).

It also tracked 3 secondary outcomes, for example Incidence of side effects, Incidence of major complications and Drop in hemoglobin measurement.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Carbetocin in 72 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.