Cooling the Uterus in C-section After Dysfunctional Labor

What Was Tested

In this not phased trial, researchers set out to test Oxytocin.

It had two arms (groups): Control Group (other) and Study Group (experimental).

The registry classes the interventions as drug and other.

More on the Plan

Two hundred patients will be drawn from all pregnant women who require a cesarean delivery for dysfunctional labor.

Dysfunctional labor will be defined as cervical dilation of 3 or more centimeters, in active labor without cervical change for 2 or more hours.

Patients will be randomly assigned to the study group or the control group, and each group will have 100 patients.

Following the delivery of the fetus, patients in the control group will have IV Pitocin administered per the usual protocol and the uterus will be wrapped in lab sponges soaked in room-temperature saline while the uterine incision is closed per the attending obstetrician's usual practice.

Who Took Part

Enrollment: 8 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Pregnant women of any age. Gravidity and gestational duration who present for cesarean section and who have given informed consent to be in the study.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: women who refuse to be in the study; women who are unable to consent due to emergent nature of the cesarean section.

How the Study Was Run

It was run as a randomized and parallel-group study.

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

The Oxytocin group and the comparison group ran side by side rather than switching.

It started in 2015-05-14 with completion listed for 2017-11-10.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Estimated Blood Loss (time frame: up to 24 hours after surgery).

It also tracked 2 secondary outcomes, for example Change in Hematocrit and Need for use of uterotonic medications.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 8 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.