Continued Versus Discontinued Oxytocin Stimulation of Labour

• Status: Completed
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborators: Aalborg Universitetshospital; Aalborg University Hospital; Aarhus University Hospital; Herning Hospital; Hillerod Hospital, Denmark; Hvidovre University Hospital; Kolding Sygehus; Odense University Hospital; Randers Regional Hospital; Rigshospitalet, Denmark; University of Amsterdam
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

• Women stimulated with Syntocinon® infusion for induction of labour (with or without cervical priming by prostaglandin)

Exclusion Criteria:

• Unable to read and understand the Danish language or to give informed consent

• Cervical dilatation > 4 cm

• Non-cephalic presentation

• Multiple gestation

• Pathological fetal heart rate pattern (cardiotocogram, CTG) before Syntocinon® initiation

• Fetal weight estimation > 4500 g (clinical or ultrasonic)

• Subject declines participation

• Gestational age less than 37 completed weeks

Definition: Stimulation with Syntocinon® following Premature Rupture of membranes (PROM) is induction of labour if there is no cervical change prior to starting the infusion, whereas stimulation with Syntocinon after PROM but following the establishment of significant cervical change is augmentation.