Continued Versus Discontinued Oxytocin Stimulation of Labour

Summary

Background:

The proposed study will investigate the effect of Syntocinon® (synthetic oxytocin) to induce labour. The hypothesis to be studied is that once the active phase of labour has commenced, Syntocinon® can be discontinued and the labour process will continue.

Design:

Double-blind randomised controlled multicentre trial

Setting:

Aarhus University Hospital, Denmark and Regional Hospital of Randers, Denmark

Population:

1200 women (600 in each group) stimulated in the latent phase of labour with oxytocin for induction

Methods:

The Syntocinon® infusion will be replaced with either continuous isotonic saline (placebo) or Syntocinon® infusion (control group), when the active phase of labour is reached.

Main outcome measures:

Caesarean section (primary outcome), tachysystole, neonatal asphyxia, birth experience

Perspective:

Syntocinon® is on the list high-alert medications and associated with complications for mother and child during labour. Reducing the duration of stimulation during labour may lower the number of asphyxial sequelae and the number of caesarean sections.

Conditions

• Adverse Reaction to Oxytocin

Interventions

DRUG

Oxytocin

Both arms will initially receive routine treatment with oxytocin according to national guidelines. When active phase of labour is established both arms will have their infusion-set changed for a blinded infusion-set.

DRUG

Placebo

Both arms will initially receive routine treatment with oxytocin according to national guidelines. When active phase of labour is established both arms will have their infusion-set changed for a blinded infusion-set.

Sponsors & Collaborators

• Randers Regional Hospital

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Kolding Sygehus

  collaborator OTHER

• Aalborg University Hospital

  collaborator OTHER

• Herning Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• University of Amsterdam

  collaborator OTHER

• Hillerod Hospital, Denmark

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Hvidovre University Hospital

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Niels Uldbjerg, DMSc · Aarhus University Hospital

• Pinar Bor, PhD · Regionalhospital Randers

• Julie Glavind, PhD · Regionalhospital Randers

• Philip Steer, BSc · Imperial College, London, England

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2020-07-01

Completion

2020-07-01

Countries

• Denmark
• Netherlands

Study Locations