Continued Versus Discontinued Oxytocin Stimulation of Labour in a Double-blind Randomised Controlled Trial (CONDISOX)

NCT02553226 Phase 4 COMPLETED

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.

Details

Lead sponsor	University of Aarhus
Phase	Phase 4
Status	COMPLETED
Enrolment	1200
Start date	2016-04
Completion	2020-07-01

Conditions

• Adverse Reaction to Oxytocin

Interventions

• Oxytocin
• Placebo

Primary outcomes

• Caesarean section — labour
  Frequency of acute performed caesarean sections

Countries

Denmark, Netherlands