Comparison of IV Ergonovine With IM Carboprost, With Oxytocin IV, During Cesarean Section for Failure to Progress

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

Patients having Cesarean section after they have been in labor for many hours bleed much more, in average twice as much, as compared with patients having an elective Cesarean section.

This study will involve the use of oxytocin (also known as syntocinon), ergonovine (also known as ergot) and carboprost (also known as hemabate).

It had three arms (groups): Oxytocin only (active comparator), Oxytocin + Ergot (active comparator) and Oxytocin + Carboprost (active comparator).

The registry classes the interventions as drug.

More on the Plan

This could be also the reason for a greater risk of uterine atony and postpartum hemorrhage (PPH) seen in women requiring induction and augmentation of labor.

Who Took Part

105 actual participants took part.

It was open to women only aged from 14 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Patients who give written informed consent. Patients undergoing Cesarean section for failure to progress in labour, under regional anesthesia. Patients should be in the first stage of labour and have received oxytocin for at least 4 hours.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: patients who refuse to give written informed consent; patients who require general anesthesia; patients who claim allergy or hypersensitivity to oxytocin, ergot derivatives or prostaglandins.

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.

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

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

It started in 2013-06-04 with completion listed for 2019-07-08.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Need for additional uterotonics intraoperatively (time frame: 1 hour).

It also tracked 6 secondary outcomes, for example Need for blood transfusion, Vital signs, Side effects, Estimated blood loss and Need for additional uterotonics or interventions post-operatively.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 105 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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