Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility

What Was Tested

In this phase 1 trial, researchers set out to test Oxytocin.

This is a Phase I open-label, parallel-group clinical study in healthy term pregnant females undergoing a caesarean section.

Two administrations of oxytocin will be tested, after which uterine contractility will be assessed.

It had two arms (groups): Oxytocin intravenous (experimental) and Oxytocin tablet (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 4 actual participants took part.

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

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

Examples of who could join: Healthy, term pregnant female with a gestational age of 37-42 weeks (singleton). Undergoing a planned primary and uncomplicated caesarean section (CS) for their first born under regional anaesthesia. Aged between 18 and 40 years (both inclusive). Ability to communicate well with the Investigator and to comply with the requirements of the entire study. Willing to give informed consent in writing.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: being obese with bmi ≥35 before pregnancy; history of, or existing thromboembolic, cardiovascular or cerebrovascular disorder; history of cervical cancer.

How the Study Was Run

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

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

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

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2018-04-03 with completion listed for 2019-06-27.

It ran at 1 site in Sweden.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Uterine contractility: area under the curve (AUC) (time frame: 3 hours).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 4 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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