Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage

What Was Tested

This registered phase 2 trial tested Oxytocin.

It had two arms (groups): Sublingual Oxytocin (experimental) and Intramuscular Oxytocin (other).

Sublingual administration of oxytocin.

Reference product is intramuscular administration of oxytocin.

The registry classes the interventions as drug.

Who Took Part

The registry lists 330 planned participants were the target.

It was open to women only aged from 18 years up to 40 years.

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

Examples of who could join: Women willing and able to provide Informed consent. Women who are able to understand, confirm and give informed consent during an antenatal visit or first stage of labor (cervical dilation \<6 cm). Healthy, primiparous or multiparous (2-4 deliveries), term-pregnant female with a gestational age of 37 to 42 weeks (inclusive). Gestational age should be confirmed with an obstetrical ultrasound if available. Aged between 18 and 40 years (both inclusive). Confirmed singleton pregnancy.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: women who are unable to provide written informed consent; women undergoing an elective or emergency cesarean section; women who have undergone female genital mutilation.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2026-05-30 with completion listed for 2026-10-30.

It ran at 1 site in Nigeria.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Proportion of participants with a satisfactory uterine tone and cumulative blood loss < [amount hidden].

It also tracked 10 secondary outcomes, for example Proportion of participants with satisfactory uterine tone, Measurement of blood loss, Proportion of participants who develop primary PPH, Incidence of blood transfusion due to PPH, Incidence of laparotomy for the treatment of PPH and Proportion of participants that achieve cessation of active bleeding.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 330 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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