Oxytocin Infusions and Blood Loss in Patients Undergoing Elective Cesarean Delivery.

What Was Tested

In this phase 3 trial, researchers set out to test Oxytocin.

It had two arms (groups): Oxytocin Infusion 1 (experimental) and Oxytocin Infusion 2 (active comparator).

The registry classes the interventions as drug.

More on the Plan

Pregnant patients undergoing elective (scheduled)Cesarean delivery routinely receive oxytocin after delivery of the baby.

Post-delivery, oxytocin is commonly administered as an IV bolus and/or infusion.

No previous studies have accurately assessed differences in oxytocin infusions after delivery in patients undergoing elective cesarean delivery.

Who Took Part

51 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 pregnant patients with uncomplicated pregnancies:. ASA (American Association of Anesthesiologists) class 1 or 2 patients.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: ASA class 3 or 4 patients; known drug allergy to intravenous oxytocin; known uterine abnormality.

How the Study Was Run

Design: randomized, single-group and quadruple-blind.

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

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

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

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

It started in 2013-08 with completion listed for 2015-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Total Estimated Blood Loss (time frame: immediately at end of surgery).

It also tracked 1 secondary outcome, for example Hemoglobin Indices After Cesarean Delivery.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 51 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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