Early Versus Delayed Oxytocin Infusion Following Amniotomy in Nulliparous Women

What Was Tested

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

In UKM Medical Centre (UKMMC), delayed oxytocin augmentation at two hours following amniotomy is the routine obstetric practice in spontaneous or induced labour with intact membranes.

It had two arms (groups): Early oxytocin Infusion (experimental) and Late oxytocin infusion (active comparator).

Labour augmentation with oxytocin was started early following amniotomy.

Oxytocin augmentation was delayed at two hours after amniotomny and this practice is currently being used as standard protocol in this hospital to manage women in labour.

The registry classes the interventions as other.

More on the Plan

This was a randomised controlled trial undertaken in the labour room of UKMMC for a period of eighteen months from August 2014 until February 2016.

Eligible women who were admitted in spontaneous labour or for induction of labour were recruited.

For women who underwent induction of labour, an interval of at least six hours following vaginal prostaglandin before recruitment was mandatory to avoid overlapping effect of prostaglandin and oxytocin.

Upon enrolment, each patient was given a study explanation and written consent was obtained.

Who Took Part

Enrollment: 250 actual participants took part.

It was open to women only aged from 19 years up to 45 years.

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

Examples of who could join: Gestational age between 36+0 to 41+6 weeks. Singleton pregnancies in cephalic presentation. Estimated fetal weight between 2.5 - 4.0 kg. Cervical dilatation of 4 cm with intact membranes. Normal fetal heart rate trace before artificial rupture of membranes.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: fetal abnormality (eg. fetal growth restriction or small for gestational age \< 2.5 kg, suspected macrosomia \> 4.0 kg, fetal anomaly).

How the Study Was Run

Design: randomized, parallel-group and single-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.

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

In this single-blind Oxytocin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2014-08-01 with completion listed for 2016-01-30.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Achieving vaginal delivery (time frame: through study completion, an average of 18 months). Neonatal outcome (time frame: through study completion, an average of 18 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 250 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.