High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour

What Was Tested

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

Primary outcome is caesarean delivery rate.

Secondary outcomes are: Apgar score, need of neonatal intensive care, hyper-stimulation of contractions, spontaneous vaginal birth rate, length of labour, postpartum haemorrhage, sphincter lacerations, experienced labour pain, epidural analgesia and the women´s childbirth experience one month postpartum (assessed with Childbirth Experience Questionnaire).

It had two arms (groups): one (experimental) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

Infusion with synthetic oxytocin is a commonly used treatment of hypotonic uterine contractions.

Secondary outcomes are Apgar score, need of neonatal intensive care, hyper-stimulation of contractions, spontaneous vaginal birth rate, length of labour, postpartum haemorrhage, sphincter lacerations, experienced labour pain, epidural analgesia and the women´s childbirth experience one month postpartum (assessed with Childbirth Experience Questionnaire).

Based on a sample size calculation (α=0.05, β=0.80), 1045 women will be needed in each group.

Analysis will be performed by the intention to treat.

Who Took Part

1376 actual participants took part.

It was open to women only aged from 18 years up to 60 years.

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

Examples of who could join: Healthy nulliparous women. Spontaneous onset of active labour. At term (37 - 42weeks gestation). Delay or arrest of active labour.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: non-swedish speaking women; previous uterine surgery; malpresentation at time of inclusion.

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.

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

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2013-08 with completion listed for 2016-06-09.

It ran at 2 sites in Sweden (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Caesarean delivery rate (time frame: At birth).

It also tracked 10 secondary outcomes, for example Spontaneous vaginal birth rate, Length of labour, Hyper-stimulation of contractions, Postpartum haemorrhage, Sphincter lacerations and Epidural analgesia.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 1376 people.

With 1376 participants it is a large trial for this field.

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.