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 |
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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). |
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Outcomes | Vaginal delivery LTCS labour induction Chorioamnionitis Composite neonatal outcome |
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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 |
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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. |