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

Dare 2002.

Methods Randomised controlled trial
Participants Setting: Owolowo University teaching hospitals, Ile‐lfe, Nigeria
Duration of study: 18 months (1 January 1998 to 31 May 2000)
Inclusion criteria: “Singleton gestation in the cephalic presentation at 38 weeks gestation, early confirmation of pregnancy by ultrasonography and no contraindications to vaginal delivery” Page 283
Exclusion criteria: “closed cervix not amenable to stripping at 38 weeks gestation, placenta praevia, medical complications of pregnancy such as insulin dependent diabetes mellitus, rupture of fetal membranes, unexplained vaginal bleeding, intrauterine growth restriction or a prior uterine incision” Page 283
Parity: mixed. both nulliparous and multiparous women included (% presented in Table 1 of manuscript page 284).
Bishop score: recorded (% presented in Table 1 of manuscript page 284).
Interventions Membrane sweep (n = 69): “membrane stripping” “Stripping of the membranes was performed by separating approximately 2‐3cm of chorionic membranes from the lower uterine segment using two circumferential passes of the examining finger” Page 283
Control group (n = 68): “gentle cervical examination” Page 283
“All patients were examined by the same person to minimise subjective differences in evaluation. Bishop scores were recorded for all patients”
Membranes stripping or gentle cervical examination, performed by 1 clinician.
Outcomes Spontaneous vaginal delivery
Assisted delivery
Caesarean section
Chorioamnionitis
Apgar score < 7 at 5 minutes
Neonatal death (congenital heart defects)
Notes Funding: none declared
Trial authors’ declaration of interest: none declared
Informed consent obtained:“all candidates gave signed informed consent before randomization”
Ethical approval: yes; “This study was approved by the hospital ethical committee on human investigation”
Email sent 30 August 2017, 26 October 2017. No reply to date
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk “computer‐generated random schedule”. Page 283
Allocation concealment (selection bias) Low risk “The allocation of assignment was concealed by placement in a numbered, opaque sealed envelope which was drawn in consecutive order”. Page 283
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants: not discussed
Personnel: “examined by the same person to minimise subjective differences in evaluation” Page 283
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.“One hundred and sixty‐nine women were eligible for the study of whom 11 (6%) declined to participate. Of the 158 who signed the consent, nine were lost to follow‐up and 12 were excluded because of long, closed cervices not amenable to stripping” < 20%". Page 284
Selective reporting (reporting bias) Low risk No evidence of selective reporting bias.
Other bias Low risk No evidence of other bias.