Oxytocin And Uterotonic Agent Use For Cesarean Delivery

What Was Tested

In this phase 4 trial, researchers set out to test Oxytocin.

Secondary outcomes to be evaluated will be: 1.

It had two arms (groups): Standard Care Group (active comparator) and Protocol Group (active comparator).

The registry classes the interventions as drug.

More on the Plan

The current guidelines for the administration of oxytocin during cesarean delivery are diverse, empiric, and vague.

A stepwise, standardized, checklist driven algorithm for the use of oxytocin and other uterotonic agents during cesarean delivery is needed to guide practitioners in a clear and concise manner.

Who Took Part

60 actual participants took part.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: American Society of Anesthesiologists (ASA) I or II health status. Age between 18 and 50 yrs. Singleton pregnancies in vertex position. Elective (without prior labor) cesarean delivery with a planned lower uterine (pfannenstiel) incision.

The full record lists 4 inclusion and 1 exclusion criteria; among the exclusions: conditions that predispose to uterine atony and postpartum hemorrhage.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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.

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

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

It started in 2011-04 with completion listed for 2012-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone (time frame: Up to 15 min from time of infant delivery).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 60 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.