Brane 2014.

Study characteristics
Methods	RCT
Participants	Number of women randomised: 138 Setting: Stockholm, Sweden Study conducted: women recruited June 2007 to May 2012 Inclusion criteria Nulliparous low‐risk women Normal pregnancies With contractions Singleton fetus with cephalic presentation GA: between 37+0 and 41+6 confirmed by ultrasound < 20 weeks Cervical dilation < 4 cm and intact membranes Able to speak, read and understand Swedish Exclusion criteria Not stated State of cervix: Bishop score at presentation ranged from 1‐8 in induction group and 2‐9 in EM group.
Interventions	Induction group (n = 71): 5 hours after medication to promote 'therapeutic rest' IOL performed, with method dependent on state of cervix: intravaginal PGE2 or transcervical catheter +/‐ AROM if cervical dilation permitted; followed by IV oxytocin (augmented every 20‐30 minutes) if no progress after AROM versus EM group (n = 67): spontaneous labour awaited as long as possible; IOL if women wanted, or if the obstetrician/midwife considered suitable
Outcomes	Mother: mode of birth; experience of birth; duration of labour; labour analgesia; oxytocin for augmentation; birth presentation; postpartum haemorrhage; sphincter tears Baby: Apgar score < 7 at 5 minutes; cord artery metabolic acidosis; birthweight; head circumference; admission to NICU
Notes	Women in both groups given medication to promote 'therapeutic rest' (1 g paracetamol, 10 mg zolpidem, 10 mg morphine). During active phase of labour (cervical dilation ≥ 4 cm or ROM) women monitored according to local protocol; slow progress (arrest of dilation for 2‐3 hours) was treated with AROM or oxytocin Funding: Karolinska Institute Foundations and Funds Declaration of interests: The authors reported no conflicts of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"The randomization was performed in blocks of 5–10 in each group." Method of sequence generation not reported
Allocation concealment (selection bias)	Unclear risk	"A sealed envelope containing coded protocols for the respective groups… was opened by the midwife." No further detail provided
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding was not feasible.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Blinded outcome assessment was not mentioned.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Some attrition and missing data, particularly for the women’s views questionnaire. Most of the sample were included in the analyses for the primary outcome (65/71, and 64/67 in main analysis for mode of birth). The reasons for missing data for some clinical outcomes were not reported.
Selective reporting (reporting bias)	Unclear risk	No access to trial protocol to confidently assess selective reporting. Perinatal death not reported
Other bias	Low risk	Appeared to be free of other bias