Sublingual Misoprostol in Reduction of Caesarean Blood Loss

What Was Tested

This registered not phased trial tested Oxytocin.

It had two arms (groups): Misoprostol (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

It would be a double blind randomized controlled trial.

The Placebo study arm would receive two sublingual placebo tablets similar to the misoprostol tablets.

The Misoprostol and the Placebo tablets will be given in each study arm at the point of starting the uterine incision at caesarean section.

Both study arms would receive routine intravenous oxytocin at the time of clamping of the umbilical cord.

Who Took Part

The registry lists 152 planned participants were the target.

It was open to women only.

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

Examples of who could join: Pregnant women at term (37+0 weeks to 41+6 weeks gestational age) for elective or non-elective caesarean sections. Pregnant women who have risk factor for primary postpartum haemorrhage. Pregnant women who consent to participate in the study.

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: pregnant women who withhold consent to participate in the study; caesarean sections for dire emergencies (umbilical cord prolapse, suspected fetal distress and active antepartum haemorrhage); previous caesarean sections or other uterine surgeries.

How the Study Was Run

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

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

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 2023-03-14 with completion listed for 2023-10-14.

It ran at 1 site in Nigeria.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Estimated volume of intraoperative blood loss (time frame: Immediate postoperative period).

It also tracked 4 secondary outcomes, for example Additional intraoperative oxytocic, Postoperative blood transfusion, Side effect profile and Postoperative haematocrit level.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 152 people.

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

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