The REDUCED-I Pilot Trial: REDucing the Utilization of CEsarean Sections With Induction

What Was Tested

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

This pilot project is a randomized controlled trial where induced patients receive an intervention of oxytocin discontinuation once in the active stage of labor (≥6 cm dilation).

It had two arms (groups): Intervention site (Foothills Medical Centre): Continuation of Oxytocin (experimental) and Intervention site (Foothills Medical Centre): Discontinuation of oxytocin (placebo comparator).

Participants in this arm will receive a blinded vial of oxytocin once a patient is found to be \>= 6 cm dilated.

Participants in this arm will receive a blinded vial of saline solution once a patient is found to be \>= 6 cm dilated.

The registry classes the interventions as drug.

More on the Plan

This pilot project is a randomized controlled trial of a proposed intervention to modify management of labor inductions once in the active first stage of labor.

The intervention will take place at Foothills Medical Centre (FMC).

Randomization will be computer generated, participants will be stratified by need for cervical ripening and randomization will be blocked.

Participants will be primiparous women 18 years old or older, at term (≥ 37 weeks) with a cephalic presenting singelton fetus undergoing induction of labor with oxytocin.

Who Took Part

The registry lists 205 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 undergoing induction of labor with oxytocin. 18 years old or older. At term (≥37 weeks).

The full record lists 6 inclusion and 2 exclusion criteria; among the exclusions: multiple pregnancies; known fetal congenital or chromosomal anomalies.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

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

It started in 2021-10-25 with completion listed for 2024-02-15.

It ran at 1 site in Canada.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Rate of Cesarean section in labor (time frame: At Delivery). Occurrence of Uterine Hyperstimulation (time frame: During labour, after >=6 cm dilation). Proportion of screened subjects who agree to enroll in the trial (time frame: During screening of potential participants).

It also tracked 9 secondary outcomes, for example Rate of neonatal asphyxia, Rate of moderate or severe asphyxia (Sarnat) or meets criteria for therapeutic cooling, Rate of neonatal sepsis or suspected sepsis, Rate of postpartum hemorrhage, Rate of blood transfusion and Rate of postpartum uterine artery/pelvic artery embolization.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 205 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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