Haugland 2012.
Study characteristics | ||
Methods | RCT | |
Participants | Inclusion: singleton pregnancy, > 37 weeks, indication to induce birth, BS < 2 cm, term date set by US before week 21 Exclusion: IUFD, fetal malformations, low lying placenta, rupture of membranes, no understanding of Norwegian language |
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Interventions | Foley catheter (n = 90), 16‐19 hours Cook double balloon (n = 88), 16‐19 hours |
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Outcomes | Cervix dilatation ≥ 3 cm after removal or active labour | |
Notes | Abstract only Setting: Haukeland university hospital, Bergen, Norway Study period: March 2010 ‐ January 2011 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) | Unclear risk | Randomisation not described |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind, says in the protocol that participants and outcome assessor will be blind to allocated treatment, but not clinicians |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind, in the study protocol says participant and outcome assessor will be blind to allocated treatment |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | ITT not described mentioned, to little information to judge |
Selective reporting (reporting bias) | Unclear risk | Insufficient information |
Other bias | Unclear risk | Abstract only, too little information to judge risk of bias |