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

Janakiraman 2011.

Methods Randomised controlled trial
Participants Setting: Outpatients obstetric clinic, USA
Duration of study: not stated
Participants randomised: N = 123
Inclusion criteria: “All women who presented to an outpatient obstetrics clinic who were >/= 37 weeks, were candidates for vaginal delivery and qualified for GBS prophylaxis were offered enrolment.” (Page S41).
Parity: mixed. Both nulliparous and multiparous women included (Page S41).
Bishop score: not stated
Interventions Membrane stripping (N = 61): in the intervention group sweeping was attempted at each visit (Page S41).
Control group (N = 62): no membrane sweeping was attempted. Standard CDC protocol antibiotic prophylaxis was given (Page S41).
Outcomes Vaginal delivery
LTCS
labour
induction
Chorioamnionitis
Composite neonatal outcome
Notes Funding: none declared
Trial authors’ declaration of interest: none declared
Informed consent obtained: not stated
Ethical approval: not stated
Email requesting further information sent 11 April 2017
Reply 26 April 2017
"The women in the membrane sweep group that were not swept were mostly because they had a closed cervix (they were randomized before a cervix exam was done)
The women that were in the no sweep group that were swept usually had their membrane swept because of provider or patient preference."
Further information requested. Reply received 8 September 2017
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk “randomized using random number generation and block randomization”
Allocation concealment (selection bias) Unclear risk Not reported.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants: not blinded.
Personnel: not blinded.
“No blinding was attempted”
Blinding of outcome assessment (detection bias) 
 All outcomes High risk “No blinding was attempted”
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Abstract of conference proceeding. “7 women withdrew from the study or were lost to follow‐up” (4/61 women from the intervention group, 3/62 women from the control group) < 20%.
Selective reporting (reporting bias) Unclear risk Abstract of conference proceeding. Full trial not available per author. 3 (4.9%) women in the control group received 1 membrane sweep (table). 19 (31.7%) of women in membrane sweep group received no sweep.
Other bias Low risk Abstract of conference proceeding. Full trial not available per author. However, no other bias noted.