Continued Versus Discontinued Oxytocin Stimulation of Labour
Status:
Completed
Trial end date:
2020-07-01
Target enrollment:
Participant gender:
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
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