Sahraoui 2005.

Study characteristics
Methods	RCT
Participants	Number of women randomised: 150 Setting: Sousse, Tunisie (Tunisia) Study date: not reported Inclusion criteria 410 to 416 weeks Dates concur with ultrasound before 20 weeks Regular menstrual cycle length 28‐30 days Not on contraception for 3 months prior to conception Singleton pregnancy Morphologically normal ultrasound Intact membranes Bishop score < 4 at initial exam No medical or obstetric complications(?) Exclusion criteria Presence of risk factors for complication (hypertension, pre‐eclampsia, diabetes, placenta praevia) Fetal‐pelvic disproportion More than 5 previous pregnancies Previous caesarean section Previous IUFD Medical contraindication to the use of prostaglandins (asthma, glaucoma, heart disease, allergy to prostaglandins) State of cervix: cervix unripe (Bishop score < 4)
Interventions	Induction group (n = 75): PGE2 gel intracervically (daily cervical ripening by PGE2 gel, maximum 3 gels) versus EM group (n = 75): CTG every second day until 42 completed weeks. After that, PGE2 gel if no spontaneous labour
Outcomes	Mother: duration of labour; mode of birth; GA at birth; duration of mother’s hospital stay (hours); need for augmentation of labour using synthetic oxytocin (Recours aux ocytociques); effect of Bishop score on admission on duration of labour (Effet du score de Bishop à l’admission sur la durée (duration) du travail (labour); progress in labour; time between final dose of PE2 gel and birth Baby: duration of infant’s hospital stay (hours); total cost of care; admission to neonatal unit; stained amniotic fluid; Apgar score at 1 minute; perinatal death; stillbirth; neonatal death; macrosomia; signs of post‐maturity; need for resuscitation at birth; number of doses of gel administered
Notes	This article is in French. Funding: not reported Declaration of interests: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation by computer
Allocation concealment (selection bias)	Unclear risk	Article in French. Appeared not to have been reported
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	Low risk	No apparent losses to follow‐up or exclusions
Selective reporting (reporting bias)	Unclear risk	No access to trial protocol to confidently assess selective reporting
Other bias	Low risk	Appeared to be free of other bias