Ugwu 2014.

Methods	Randomised controlled trial
Participants	Setting: Nigeria Teaching Hospital (UNTH), Enugu, Nigeria Duration of study: February 2012 – November 2012 Participants randomised: N = 134 Inclusion criteria: “All uncomplicated singleton pregnancies at a gestational age of 40–41 weeks, without uterine contractions” (Page 30). Exclusion criteria: “unsure of date, pre‐conception irregular menstrual cycle, evidence of any contraindication to vaginal delivery, medical diseases in pregnancy, and term premature rupture of membranes.” (Page 30). Parity: mixed. Both nulliparous and multiparous women were included in this study. Bishop score: Pre‐recruitment Bishops score was recorded (Table I, Page 32).
Interventions	Membrane stripping (n = 67): “membranes stripped under aseptic procedure in the antenatal clinic of the hospital without hospital admission. With the woman in dorsal position, initial cervical assessment for the Bishop score was carried out. Thereafter, the investigator’s examining finger was introduced into the cervical os. Then, the fetal membranes were digitally separated from the lower uterine segment by two circular movements of the introduced finger. Where the membranes could not be reached, digital stretching of the cervix was attempted, followed by membrane sweeping, when successful. In cases of failed digital cervical stretching or unfavorable cervix (low bishop score), cervical massaging in the vaginal fornices was performed for 10 s. Each participant in the membrane sweeping group was observed for 1 h in the clinic after the procedure. Prophylactic antibiotics were not administered after the stripping of membranes.” (Page 30). Control group (N = 67): “vaginal examination only to assess the initial Bishop score.” (Page 30).
Outcomes	Spontaneous vaginal delivery Assisted vaginal delivery Caesarean section Apgar < 7 at 5 minutes Chorioamnionitis Spontaneous labour within 72 hours of intervention Formal induction of labour
Notes	Funding: none declared. Trial authors’ declaration of interest: none declared. Informed consent obtained: yes “written informed consent” (Page 30). Ethical approval: yes.“obtained from the Institutional Review Board of the UNTH, Enugu.” (Page 30). Author contacted 8 August 2017 to clarify trial data Further email sent 28 September 2017. Author reply as follows: (1.) Question: Can you please clarify why there were 2 sets of random numbers (1 to 134) and how these were used to conceal allocation? Ans: First, by 2 sets of random numbers we meant...a set of 67 random numbers for intervention group (labelled A) and another set of 67 random numbers for control group (labelled B), making a total of 134. Each envelop containing a 5 x 5 cm white paper labelled either ‘‘A’’ for intervention group or ‘‘B’’ for control group, was opaque and sealed. They were kept by a third party (neither the researchers nor the patients) who did not know about the research objectives. (2.) Question: The data for the following outcomes are reported for only the women who did not go post‐term (> 41+3). Is it possible for you to provide the outcome data on all women so it may be included in our review? Spontaneous vaginal birth Caesarean section Instrumental vaginal delivery Augmentation of labour Apgar score less than 7 at 5 minutes Answer: "Unfortunately our study was not designed to include intention to treat analysis. So, we limited our data collection and analysis to women who delivered before "post‐term" (41+3)."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“…computer‐based random sequence generator…” also “…two sets of random numbers (1 to 134) corresponding to the intervention and control groups…” Email sent to author to clarify: Question: Can you please clarify why there were 2 sets of random numbers (1 to 134) and how these were used to conceal allocation? Answer 17 August 2017: "First, by 2 sets of random numbers we meant...a set of 67 random numbers for intervention group (labelled A) and another set of 67 random numbers for control group (labelled B), making a total of 134."
Allocation concealment (selection bias)	Low risk	Sealed opaque envelopes were labelled sequentially from 1 to 134 by the statistician; each numbered envelope contained a 5 9 5 cm white paper labelled either ‘‘A’’ for intervention group or ‘‘B’’ for control group, corresponding to appropriate number set described above. The envelopes were kept by a medical intern (third party), blinded to the study’s objectives. Furthermore, serial numbers 1–134 were consecutively assigned to each recruited woman following an informed consent. Page 30. Email sent to author to clarify. Answer 17 August 2017: ”Each envelop containing a 5 x 5 cm white paper labelled either ‘‘A’’ for intervention group or ‘‘B’’ for control group, was opaque and sealed. They were kept by a third party (neither the researchers nor the patients) who did not know about the research objectives.”
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding of participants: not reported Blinding of personnel: not reported
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported.
Incomplete outcome data (attrition bias) All outcomes	Low risk	"Eleven participants delivered outside the study centre and were lost to follow‐up" < 20%. Author reports 17/08/2017: "Unfortunately our study was not designed to include intention to treat analysis".
Selective reporting (reporting bias)	High risk	Reported data did not include women (membranes sweeping n = 10, and control n = 24) whose pregnancies progressed to post‐term pregnancy. Author contacted for clarity: Reply 17/08/2017: "Unfortunately our study was not designed to include intention to treat analysis. So, we limited our data collection and analysis to women who delivered before "post‐term" (41+3)."
Other bias	Low risk	No evidence of other bias