NCT02553226.

Trial name or title	CONDISOX‐ Continued versus discontinued oxytocin stimulation of labour in a double‐blind randomised controlled trial.
Methods	Double‐blind multicentre randomised controlled trial.
Participants	1200 women stimulated with Syntocinon® infusion for induction of labour (with or without cervical priming by prostaglandin).
Interventions	Latent phase: stimulation will be given according to national guidelines: initially 20 mL/hour of 10 IE Syntocinon® diluted in 1000 mL 0,9% NaCl. The dose rate will be increased every 20 minutes by 20 mL/hour until appropriate uterine activity of 3 to 5 contractions per 10 minutes is achieved. The maximum allowed dose rate 180 mL/hour for induction of labour. Active phase: the woman will be included in the study and randomised, when the active phase of labour is established (cervical dilatation ≥ 6 cm, ≥ 3 contractions per 10 minutes, and rupture of membranes). When the active phase of labour is established is oxytocin infusion replaced with project medicine. Control group; 10 IE Syntocinon® diluted in 1000 mL 0,9% NaCl infusion. Intervention group; 1 mL 0,9% NaCl diluted in 1000 mL 0,9% NaCl infusion
Outcomes	Primary outcome Delivery by caesarean section Secondary outcomes Birth experience and satisfaction 4 weeks postpartum (Childbirth Experience Questionnaire, CEQ1, Dencker 2010). Maternal: instrumental delivery, duration of the active phase of labour (from time of randomisation to delivery), total duration of labour (from initiation time of oxytocin stimulation until delivery), duration of admission on the delivery ward, tachysystole, hyperstimulation, use of epidural analgesia, dose and duration of oxytocin infusion, episiotomy, rupture of the anal sphincter, uterine rupture, volume of blood loss at delivery and postpartum, need for evacuation of retained products of conception, use of antibiotics during labour, postpartum infection (defined as 2 measured maternal temperatures of 38ºC at least 4 hours apart), retention of urine requiring catheterisation). Neonatal: birthweight, CardioTocoGram (CTG) classification, fetal scalp pH values, Apgar score at 1 and 5 minutes, umbilical cord arterial and venous pH and blood gas values, use of antibiotics, hyperbilirubinaemia, neonatal admission to NICU, need for resuscitation (bag and mask or intubation, time to onset of spontaneous ventilation), or death. Breastfeeding (time to established feeding and duration of exclusive breastfeeding).
Starting date	April 2016
Contact information	Sidsel Boie, Department of Obstetrics and Gynecology, Randers Regional Hospital, Skovlyvej 1, 8930 Randers NØ, Denmark. e‐mail: sidselboie@clin.au.dk
Notes	www.condisox.dk (available in Danish and English) clinicaltrials.gov Identifier: NCT02553226

NaCl: sodium chloride, NICU: neonatal intensive care unit