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 |
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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 |