IV vs IM Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage

What Was Tested

This registered not phased trial tested Oxytocin.

The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via IV infusion results in a lower mean blood loss compared to IM injection.

It had two arms (groups): IV infusion (active comparator) and IM Injection (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 653 actual participants took part.

It was open to women only.

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

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: planned or transferred for delivery via cesarean section; not delivering a live birth; unable to provide informed consent due to mental impairment, distress during labor or other reason.

How the Study Was Run

It was run as a randomized, single-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Being open-label, the Oxytocin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2012-05 with completion listed for 2012-11.

It ran at 3 sites in Ecuador (1), Turkey (Türkiye) (1) and Vietnam (1).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Mean blood loss (ml) (time frame: minimum of 1 hour after delivery of baby).

It also tracked 6 secondary outcomes, for example Change in hemoglobin from pre-delivery to postpartum, Time to placental delivery, Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy, Side effects 1 hour postpartum and Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 653 people.

With 653 participants it is a large trial for this field.

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.