Labour Augmentation by Means of Oxytocin - Obstetric Outcome and Women's Experiences

What Was Tested

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

Oxytocin augmentation is widely used to treat slow labour despite associated risks for the fetus.

An ongoing debate concerns whether oxytocin should be administered directly or postponed after arrested labour.

It had two arms (groups): Expectant group (experimental) and Early oxytocin group (no intervention).

Arrest in labour progress for 2-3 hours and no progress after amniotomy. Expectancy of standard oxytocin treatment for 3 hours.

Arrest in labour progress for 2-3 hours and no progress after amniotomy. Oxytocin treatment started within 20 minutes.

The registry classes the interventions as other.

More on the Plan

In contemporary handling of labouring women in the western world, it has become extremely common to intervene through "active" or disciplined" management (Enkin et al., Widela et al., Gerdhardstein et al., Frigoletto et al).

It is a widespread routine - and potential side effects will therefore have a great impact.

The effects, when evaluated, are short-term effects of maternal (obstetric) and fetal outcomes.

Only one of the studies found sought the women's view on the augmentation procedures (Enkin).

Who Took Part

2072 actual participants took part.

It was open to women only aged from 18 years up to 48 years.

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

How the Study Was Run

The set-up was randomized and open-label.

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.

Nothing was hidden in this open-label Oxytocin study: the participants and staff both knew the treatment.

It started in 1998-10 with completion listed for 2003-12.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mode of delivery (spontaneous vaginal, instrumental vaginal or caesarean delivery).

It also tracked 4 secondary outcomes, for example Postpartum haemorrhage, Sphincter lacerations, Need of neonatal intensive care and Maternal experiences of childbirth.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 2072 people.

With 2072 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.