The Effect of Coadministration of Oral Propranolol to Oxytocin on Induction of Labor

What Was Tested

In this phase 3 trial, researchers set out to test Oxytocin.

The effect of coadministration of oral propranolol to oxytocin on induction of labor.

It had two arms (groups): propranolol plus oxytocin (active comparator) and placebo plus oxytocin (placebo comparator).

121 control patients who will receive a similar capsule as a placebo (oxytocin plus placebo) before beginning induction.

The registry classes the interventions as drug.

More on the Plan

Intervention: After taking informed consent, all patients recruited in the study will undergo complete clinical examination and detailed medical history will be obtained along with necessary laboratory investigations and ultrasound.

Each patient will have a case record form in which the following data will be recorded: 1.

History: personal (age, duration of marriage), present illness (any current medical or surgical diseases and any current medication), obstetric history (including parity, gestational age, obstetric complications) and past medical history(especially cardiac problems). 2.

General examination: assessment of vital data, cardiac and chest auscultation to exclude contraindications for drug administration. 2.

Who Took Part

The registry lists 242 planned participants were the target.

It was open to women only aged from 17 years up to 40 years.

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

Examples of who could join: Gestational age above 37 weeks. Fetal life positive on ultrasound. Bishop score \> 5.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: history of uterine surgery; contraindications to β-adrenergic agents, such as systolic blood pressure less than 100 mmhg or pulse rate less than 60/min and more than 120/min; history of any known cardiac disease.

How the Study Was Run

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

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.

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 and care provider.

It started in 2015-12 with completion listed for 2016-12.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): duration of first stage of labour (time frame: 24 hours).

It also tracked 2 secondary outcomes, for example rate of cesarean section and Apgar score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Oxytocin in 242 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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