Oxytocin Dosage to Decrease Induction Duration

What Was Tested

The trial (phase 4) is built around Oxytocin.

The randomization is stratified by maternal body mass index.

It had four arms (groups): Lean-Control (active comparator), Lean-Intervention (experimental), Obese-Control (active comparator) and Obese-Intervention (experimental).

The registry classes the interventions as drug.

More on the Plan

Obesity in pregnancy places women at higher risk of obstetrical complications during pregnancy, delivery and postpartum.

When pregnant women need help going into labor, they commonly receive a medication called Pitocin on the labor and delivery floor.

Pitocin is the brand name and is a synthetic analog to the naturally produced oxytocin, a hormone secreted by mother when they naturally go into labor.

This medication has been used widely around the world.

Who Took Part

Enrollment: 140 actual participants took part.

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

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

Examples of who could join: Singleton pregnancy ≥ 37 weeks gestation. Patient presented for induction of labor who is determined to be a candidate for oxytocin. Reassuring fetal health assessment (no abnormal findings in fetal assessment, see below). Meeting one of the following BMI category:.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: non-reassuring fetal assessment at the time of recruitment; previous cervical ripening agents (cytotec, cervidil, cervical foley balloon); \<18 years of age.

How the Study Was Run

Design: 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 2017-06-05 with completion listed for 2018-10-12.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Length of Time to Delivery (time frame: Start of induction to Delivery).

It also tracked 6 secondary outcomes, for example Maximum Oxytocin Infusion Rate, Number of Participants With Terbutaline Use, Rate of Cesarean Delivery, Rate of Cesarean Delivery for Labor Arrest, Maternal Blood Loss and Number of Neonates With Apgar Score <7.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 140 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.