Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?

What Was Tested

The trial (phase 4) is built around Oxytocin.

It had two arms (groups): Intramyometrial oxytocin (experimental) and Intramyometrial Saline (placebo comparator).

The registry classes the interventions as drug.

Who 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: Elective cesarean Delivery. Term (\> 37 wks gestational age) as defined by ultrasound or last menstrual period. Age \> 18. BMI \< 40. Height \> 5'2" and \< 5"8".

The full record lists 9 inclusion and 11 exclusion criteria; among the exclusions: placenta previa; multiple gestation; gestational diabetes or pre-existing diabetes.

How the Study Was Run

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

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

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

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

It started in 2011-08 with completion listed for 2012-04.

It ran at 1 site in Canada.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Uterine Tone (time frame: The blinded obstetrician will assess uterine tone at 1,2,4,6, 8 and 10-minute intervals).

It also tracked 4 secondary outcomes, for example Estimated Blood Loss, Pre-operative to post-operative change in hematocrit, Need for additional unterotonics and Need for blood pressure support.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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