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. 2023 Mar 30;2023(3):CD001233. doi: 10.1002/14651858.CD001233.pub4

Blumenthal 1990.

Study characteristics
Methods RCT. Randomisation by drawing a blank envelope from a stack of 50 identical envelopes containing the group allocation.
Participants Vertex, intact membranes, BS < 5, no previous CS.
Interventions Dilapan (polyacrilonitrile hydrogel) inserted in the cervix, up to 6 sticks (23 women); Laminaria inserted in the cervix, as many as possible (18 women).
Outcomes CS.
Notes Results for a 3rd group of women with favourable cervix treated with oxytocin are presented. These women are not be included in the analysis, as they were not randomly allocated to the intervention.
Setting: Michael Reese hospital, Chicago, USA
Study period:January 1987 to January 1988
Funding: not reported
Declarations of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Shuffling envelopes
Allocation concealment (selection bias) Low risk Women choose from stack of all blank, identical envelopes
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not feasible due to nature of intervention
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias)
All outcomes High risk ITT not reported. no explanation what happened to the rest of the randomised women
Selective reporting (reporting bias) Low risk All pre‐specified outcomes reported
Other bias Low risk No other bias detected