Intra-Umbilical Vein Oxytocin Injection as an Adjunct to Active Management of the Third Stage of Labour

What Was Tested

The trial (not phased) is built around Oxytocin.

This randomized controlled clinical trial evaluates the effect of umbilical vein injection of oxytocin given in addition to routine active management of the third stage of labour.

It had two arms (groups): Oxytocin group (active comparator) and Normal Saline Group (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

Postpartum haemorrhage remains one of the leading causes of maternal morbidity and mortality worldwide, particularly in low-resource settings.

Oxytocin is a uterotonic drug that promotes uterine contraction and facilitates placental separation.

Administering oxytocin through the umbilical vein allows the drug to reach the placental bed directly, which may enhance localized uterine contraction at the site of placental attachment.

Such an intervention may be particularly valuable in environments where access to blood transfusion and advanced obstetric care is limited, and where even moderate blood loss can result in serious complications.

Who Took Part

The registry lists 416 actual participants took part.

It was open to women only aged from 18 years up to 35 years.

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

How the Study Was Run

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

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.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2018-02-01 with completion listed for 2019-08-31.

It ran at 1 site in Nigeria.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Postpartum Blood Loss Measured by Calibrated Drape Weight Difference (time frame: Within 1 hour after delivery of the baby). Duration of the Third Stage of Labour Measured by Stopwatch (time frame: From delivery of the baby to delivery of the placenta).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 416 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.