Continued Versus Discontinued Oxytocin Stimulation of Labour

What Was Tested

This registered phase 4 trial tested Oxytocin.

Background: The proposed study will investigate the effect of Syntocinon® (synthetic oxytocin) to induce labour.

It had two arms (groups): Continued group (active comparator) and discontinued group (placebo) (placebo comparator).

Recieve routine treatment with oxytocin according to the danish national guidelines.

The routine treatment with oxytocin will be discontinued and replaced with isotonic saline, when the active phase of labour is established.

The registry classes the interventions as drug.

More on the Plan

Randomisation: When the orificium ≥6 cm, regular painful contractions (≥3 per 10 minutes) and rupture of membranes participants will be randomised in a 1:1 ratio to either the control (continued Syntocinon®) or intervention (discontinued Syntocinon®) group using an Internet-based randomisation programme.

The randomisation can only be performed when the woman consents to participation.

Written consent can be given after the commencement of the Syntocinon® infusion, provided the woman previously has received sufficient information for her to give properly informed consent.

The randomisation number corresponds to number of the project medicine (ampoule).

Who Took Part

Enrollment: 1200 actual participants took part.

It was open to women only aged from 18 years up to 99 years.

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

Examples of who could join: Women stimulated with Syntocinon® infusion for induction of labour (with or without cervical priming by prostaglandin).

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: unable to read and understand the danish language or to give informed consent; cervical dilatation \> 4 cm; non-cephalic presentation.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

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

It started in 2016-04 with completion listed for 2020-07-01.

It ran at 10 sites in Denmark (9) and Netherlands (1).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Caesarean section (time frame: labour).

It also tracked 29 secondary outcomes, for example Instrumental delivery, Birth experience, Breastfeeding, Duration of the active phase of labour, Total duration of labour and Uterine tachysystoli.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 1200 people.

With 1200 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.