de Miranda 2006.

Methods	Randomised controlled trial
Participants	Setting: midwifery practices, the Netherlands. Duration of study: June 2000 to March 2003. Inclusion criteria: “low risk (single fetus in cephalic presentation, no pregnancy complications or risk factors and no contraindications to normal vaginal delivery), with a reliable gestational age of 41 weeks (range 40+6to41+3)” Page 403. Exclusion criteria: “history of blood loss after the first trimester or suspicion of loss of amniotic fluid during pregnancy.”Page 403 Parity: mixed,both nulliparous and multiparous women included (Table 1 page 404). Bishop score: not recorded.
Interventions	Membrane stripping (N = 375) "Women allocated to the control group received routine monitoring. To prevent prostaglandin release, vaginal examination was not performed in the control group until the onset of labour. In addition, we asked the midwives to refrain from advice regarding sexual intercourse as a way of stimulating labour onset, regardless of the allocation." Page 403 Control group (N = 367) "Women allocated to sweeping received routine monitoring as well, followed by a vaginal examination for assessment of the cervical ripeness (Bishop score (BS)) and immediate sweeping. Sweeping was performed by separating the lower membranes as much as possible from their cervical attachment, with 3 circumferential passes of the examining fingers. When sweeping was not possible because the cervix was closed, cervical massage was performed. Massage of the cervical surface was performed with circular pushing and massaging movements of the fore finger and middle finger for approximately 15 seconds. Sweeping was repeated every 48 hours, with a maximum of 3 times, until labour commenced or 42 weeks of gestation was reached. The midwives explained to the women who had been swept that blood‐stained mucus or painful contractions could occur." Page 403
Outcomes	Spontaneous onset of labour < 42 weeks Spontaneous onset of labour ≥ 42 weeks labour induction total Epidural Spontaneous vaginal delivery Forceps delivery Vacuum delivery Caesarean section Augmentation of labour Adverse neonatal outcomes Perinatal death Women’s perception of sweep
Notes	Funding: none declared Trial authors’ declaration of interest: none declared Informed consent obtained: “A written informed consent was obtained at the antenatal visit of 41 weeks” Page 403 Ethical approval:“The ethics committee of the Academic Medical Center of Amsterdam approved the trial” Page 403 Email sent 30 August 2017 requesting data for subgroup analysis. Reply received 31 August 2017...follow‐up email sent 20 September 2017 Subgroup data received 26 October 2017
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“blocked randomisation using 30 blocks of 25,26 with a variable allocation ratio of 12:13 or 13:12” Page 403
Allocation concealment (selection bias)	Low risk	“The allocations were placed within consecutively numbered, opaque, sealed envelopes. A box containing the agreed number of randomisations (variable for each centre) was then sent to the midwifery practices where they were kept.” Page 403
Blinding of participants and personnel (performance bias) All outcomes	High risk	Personnel: “The participating midwives were unaware of the randomisation method.” Does not reference blinding for intervention. Page 403 Participants: not discussed.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	After every randomisation, the numbered envelope containing the allocation card was posted to the trial coordinator together with a randomisation form containing the date of randomisation, the allocation group and the subject characteristics.” Page 403 “Data concerning prenatal care, obstetric intervention, delivery and infant condition were recorded on a case report form (CRF).” “The midwives asked all women to complete the questionnaires.” Page 403
Incomplete outcome data (attrition bias) All outcomes	Low risk	No evidence of attrition bias. “Primary analysis was by intention to treat, i.e. three women allocated to sweeping, who did not receive the intervention, and 19 women randomised to the control group, who were nevertheless swept, were analysed according to the allocated group.” < 20% (375 in the sweeping group and 367 in the control group). Page 404
Selective reporting (reporting bias)	Low risk	No selective reporting bias noted.
Other bias	Low risk	No other bias noted.