Yildirim 2010.

Methods	Randomised controlled trial
Participants	Setting: Bakirkoy Maternity and Pediatric Diseases Training and Research Hospital, Istanbul, Turkey Duration of study: October 2006 and July 2007. Participants randomised: N = 351 Inclusion criteria: “a single live fetus in cephalic presentation, gestational age between 38 and 40 weeks as determined by the last menstrual period or by a first‐ or second‐trimester ultrasound scan, no previous cesarean section or any uterine surgery, a Bishop score < 4 in the presence of a closed cervix and no contraindication to vaginal birth”. Page 682 Exclusion criteria: “previous cesarean delivery and uterine surgery, intrauterine fetal death, twin pregnancies, estimated fetal weight 44500g, known gross fetal anomalies or breech presentation”. Page 682. Parity: mixed. Both nulliparous and multiparous women included. Women who agreed to participate were first stratified into nulliparous and multiparous groups. Bishop score: cervical status and Bishop score (median, IR) recorded.
Interventions	“Pelvic examinations were performed to assess the status of the cervix by Bishop scoring. Transvaginal ultrasonographic measurement of cervical length was performed with the standard longitudinal view of the cervix while the patient’s bladder was empty. The probe was placed in the vagina approximately 3 cm proximal to the cervix to avoid distortion of its position or shape and a sagittal view of the cervix, with the echogenic endocervical mucosa along the length of the canal, was obtained. Three measurements were obtained using a Voluson 730 Expert ultrasound machine (GE Medical Systems Kretztechnik, Zipf, Austria) equipped with a 4–11 MHz probe. The shortest measurement was recorded” Page 682 Membrane stripping (N = 179): “Sweeping was performed by separating the lower membrane as much as possible from its cervical attachment, with three 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 forefinger and middle finger for approximately 30 s. Sweeping was performed by only one of the investigators, and vaginal examination also was performed by the same investigator for the control group.” Page 682 “The women were observed for a few hours after membrane sweeping and, if they were well, they were discharged. The women were warned to expect a ‘show’ and were allowed to go home with a fetal movement chart. They were instructed to go to the labor ward if they experienced decreased fetal movement, rupture of the membranes or excessive vaginal bleeding or suspected the onset of labor.” Page 682 Control group (N = 167): vaginal examination. After the initial intervention, there were no further differences in management between the sweeping group and control group. All women were given a deadline date for labour to be induced in the absence of spontaneous onset. Thereafter, all patients were followed weekly until delivery or scheduled induction, and sweeping was not repeated. Page 682
Outcomes	Spontaneous onset of labour Vaginal delivery Caesarean section Maternal infection Maternal discomfort Neonatal mortality
Notes	Funding: not stated Trial authors’ declaration of interest: not stated Informed consent obtained: yes "Written informed consent to participate in the study was obtained from all women who entered the study" Ethical approval: the hospital ethics committee approved the study. Email requesting further information sent 30 August 2017. Resent 20 September 2017. No reply to date.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“First stratified into nulliparous and multiparous groups”. “Randomisation was carried out by using sealed opaque envelopes with a piece of paper inside marked ‘Sweep’ or ‘No Sweep’. Envelopes were prepared in blocks of 20 (10 sweep and 10 no sweep) for each stratified group. Envelopes were then shuffled and placed in boxes marked ‘nulliparous’ and ‘multiparous’. Boxes were refilled as required with blocks of 20 envelopes.” Page 682
Allocation concealment (selection bias)	High risk	“The investigator was not blinded to the allocation procedure.” “using sealed opaque envelopes with a piece of paper inside marked ‘Sweep’ or ‘No Sweep’.” “For random assignment to treatment groups, an envelope was withdrawn from the appropriate box and allocated to the woman. Once allocated, an envelope was discarded if a woman chose to withdraw, or there was an error in recruitment” Page 682.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Personnel: not blinded “The allocated envelope was opened by the clinician performing the initial vaginal examination just prior to that examination.” page 682 Participants: Study states “therefore, at this stage, neither the investigator nor the patients knew the identity of the study group”. However it also states that “The procedure allocation was recorded in the woman’s chart.” Page 682
Blinding of outcome assessment (detection bias) All outcomes	High risk	A sticker bearing the identification of the randomised woman was affixed to the paper marked ‘Sweep’ or ‘No Sweep’, and the paper was placed in a sealed drop box until unblinding at the end of the study. “Follow‐up of the patients was performed by another investigator who was blinded to which group the patients were in; therefore, at this stage, neither the investigator nor the patients knew the identity of the study group. However “The procedure allocation was recorded in the woman’s chart.” Page 682
Incomplete outcome data (attrition bias) All outcomes	Low risk	No evidence of attrition bias.“Data were analysed on an intent‐to‐treat basis” Page 682
Selective reporting (reporting bias)	Low risk	No evidence of selective reporting bias.
Other bias	Low risk	No evidence of other bias.