Bor 2016.

Methods	Randomised controlled trial.
Participants	Inclusion: women with induction or augmentation of labour with oxytocin. Exclusion: < 18 years of age, unable to give written informed consent, cervical dilation of more than 4 cm, multiple pregnancies, more than 1 prior caesarean section, non‐vertex presentation, persistent pathological cardiotocography before oxytocin infusion, an estimated fetal weight of more than 4250 g. Setting: Regional hospital of Randers, Denmark, May 2009 to May 2012 (period of inclusion). Number of included participants: 100 women in the continued group versus 100 women in the discontinued group.
Interventions	Oxytocin infusion No infusion The oxytocin infusion (5 IU oxytocin diluted in 500 mL of isotonic saline) was initiated at 3.3 mIU/minute and increased every 20 minutes by 3.3 mIU/minute until there was 3 to 5 contractions every 10 minutes) achieved. The maximal dose of oxytocin infusion was 30 mU/minute.
Outcomes	Primary Duration of the active phase of labour (from 5 cm of cervical dilation to vaginal delivery) Secondary Mode of delivery Uterine tachysystole Abnormalities in fetal heart rate Hyperstimulation (tachysystole with abnormal fetal heart rate changes) Postpartum haemorrhage Perineal tears Neonatal outcomes; Apgar score at 5 minutes, umbilical artery pH, and admission to the NICU
Notes	Sources of trial funding: the Central Denmark Region Committees on Health Research Foundation. Trial authors declare no conflict of interest. Trial registered 22 December 2006. Non‐compliance 36% in the discontinued group. GCP‐monitored trial.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomised using a computer‐generated randomisation program.
Allocation concealment (selection bias)	Low risk	Centralised real time randomisation.
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding and no placebo used.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Although there was no blinding, outcomes such as mode of delivery are objective, other outcomes are subjective and at risk of bias.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Intention‐to‐treat principle are followed. Missing values are described (up to 10% for some outcomes). Numbers and reasons provided for each group.
Selective reporting (reporting bias)	Unclear risk	Protocol published on clinicaltrialregister.eu (in Danish) (2006‐006956‐36). Primary outcome: duration of labour and duration of various phases of labour. Secondary outcomes not reported in the protocol, nor on EUdract trial register.
Other bias	Low risk	Although randomisation was performed when oxytocin infusion was initiated and not when continued or discontinued, the Consort flow diagram documents both caesarean births before the active phase and trial compliance with treatment allocation.