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. 2020 Feb 27;2020(2):CD000451. doi: 10.1002/14651858.CD000451.pub3

El‐Torkey 1992.

Methods Randomised controlled trial
Participants Setting: Antenatal clinic, district maternity hospital, UK
Duration of study: June 1990 to March 1991
Inclusion criteria: pregnant women between 41 and 42 weeks' gestation. "women who opted for induction of labour were randomly allocated to undergo sweeping of the membranes or to act as controls". Deadline date for labour induction given after randomisation. Page 456
Exclusion criteria: none stated
Parity: mixed. Both nulliparous and multiparous women included.
Bishop score: cervix > 4 cm at first exam
Interventions Membrane stripping (n = 33): “As much of the membranes as possible was separated from the lower segment” “If cervix would not admit a finger it was massaged vigorously to encourage prostaglandin release”. “Sweeping of the membranes was performed by one of the authors (M.E‐T.).” “After allocation the subjects were given a date for formal induction of labour”Page 456
Control group (n = 32):
no vaginal examination. Page 456
Outcomes Spontaneous onset of labour:
Epidural
Mode of birth
Caesarean section
Forceps
Spontaneous
Neonatal outcomes
Apgar < 6 at 5 minutes
Serious neonatal infection
Neonatal perinatal death
Notes Funding: none declared
Trial authors’ declaration of interest: none declared
Informed consent obtained: no, only women in sweeping group were "informed of the purpose of the trial". page 456
Ethical approval: no,”formal ethical approval of the study was not sought”
Unable to contact either author. Unable to locate current place of work or email address. Hospital trial was set in now closed.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation by “random permuted blocks”. Page 456.
Allocation concealment (selection bias) Unclear risk The randomisation codes were placed in opaque sealed envelopes which “were kept in the antenatal clinic”. Page 456. However not noted if envelopes were sequential or sealed.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants: "Those who were randomized to sweeping were informed of the purpose of the trial and the procedure". "The women randomized to the control group were not aware that they were taking part". Page 456.
Personnel: not reported.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No evidence of attrition bias. “Because of this marked difference in the proportions of subjects achieving spontaneous labour the trial was stopped before 110 women were recruited. The decision to stop the trial was made by the authors themselves, the decision being based on the statistical stopping rule for randomized trials (Pocock,1983)”
Selective reporting (reporting bias) Low risk No evidence of selective reporting bias noted.
Other bias Low risk No evidence of other bias noted.