Heimstad 2007.
Study characteristics | ||
Methods | RCT | |
Participants | Number of women randomised: 508
Setting: St. Olavs University Hospital, Trondheim, Norway Study date: women randomised between September 2002 and July 2004 Inclusion criteria
State of cervix: all stages included |
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Interventions |
Inductiongroup (n = 254): if cervix favourable (Bishop score ≥ 6) AROM + oxytocin, if not (Bishop score < 6) 50 µg misoprostol vaginally versus EM group (n = 254): twice‐weekly ultrasound and CTG, labour induction after 300 days of pregnancy |
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Outcomes | Mother: prolonged labour; mode of birth; perineal trauma; maternal satisfaction; postpartum haemorrhage Baby: perinatal death; neonatal morbidity, for which a score was tallied (by evaluating the degree of deviation from the potential of a perfect outcome for each newborn as defined by the authors); neonatal trauma; birthweight; birthweight > 4000 g, NICU admission, birth asphyxia, meconium aspiration syndrome, Apgar < 7 at 5 minutes | |
Notes |
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 | Computerised randomisation using blocks of 16 with no stratification |
Allocation concealment (selection bias) | Low risk | Central allocation ‐ clinical trials office |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding was not feasible. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinded outcome assessment was not mentioned. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No women were lost to follow‐up for clinical outcomes; 8 women did not complete the inclusion questionnaire; for the post‐birth telephone survey, 12 women were lost to follow‐up (4 in induction group and 8 in EM group). |
Selective reporting (reporting bias) | Unclear risk | While all prespecified outcomes (in the methods) were reported, with no access to trial protocol, it was not possible to further assess selective reporting. |
Other bias | Low risk | Appeared to be free of other bias |