Oxytocin Bolus Versus Infusion in Elective Cesarean Section"

What Was Tested

The trial (phase 4) is built around Oxytocin.

It had two arms (groups): Bolus arm (active comparator) and Infusion arm (active comparator).

The registry classes the interventions as drug.

More on the Plan

However, the optimal strategy for oxytocin administration remains controversial.

There is limited high quality data comparing bolus versus infusion administration of oxytocin.

However, the time to uterine tone appears to be slightly longer (3-4 mins) with the infusion method.

Thus, the purpose of this research study is to compare bolus and infusion administration of oxytocin on parturients undergoing elective cesarean section.

Who Took Part

The registry lists 120 planned participants were the target.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Parturients between the ages of 18 to 45 with singleton pregnancies. Undergoing elective cesarean section under spinal anesthesia. American Society of Anesthesia (ASA) physical status class I or II. Patients must be able to provide written informed consent.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: parturients in labor or ruptured membranes; multiple gestation; risk factors predisposing to uterine atony (history of placenta previa, preeclampsia, diabetes mellitus macrosomia, hydramnios, bleeding diathesis, uterine fibroids).

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.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2022-03-15 with completion listed for 2024-12-15.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Number/Proportion of Participants with Adequate Uterine tone (time frame: 2 minutes).

It also tracked 1 secondary outcome, for example Patient satisfaction questionnaire (Scale 0 to 10, 0 being complete dissatisfaction and 10 being highly satisfied.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 120 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.