Augensen 1987.
Study characteristics | ||
Methods | RCT | |
Participants | Number of women randomised: 409
Setting: Bergen, Norway Study date: 1981‐84 (no further details) Inclusion criteria
Exclusion criteria
State of cervix: mixed (about 35% in each group had unripe cervix) |
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Interventions |
Induction group (n = 214): immediate induction with oxytocin (5 IU increased in a stepwise manner). GA at intervention 41+ weeks (290‐297 days) versus EM group (n = 195): NST every 3‐4 days, IOL after 7 days |
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Outcomes |
Mother: caesarean section; assisted vaginal birth; length of labour; length of hospital stay Baby: perinatal death; birthweight; neonatal jaundice; meconium‐stained amniotic fluid; NICU admission |
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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 | List of random numbers |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was unclear given that it was not undertaken by a staff member or team member clearly uninvolved in the trial. It was reported that the midwife undertook allocation using a random number list, and this list was inaccessible to the participating physicians. |
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 | 4/214 in the IOL group went into labour before IOL but data for these women have been included in the IOL group for analyses. No apparent losses to follow‐up or exclusions. |
Selective reporting (reporting bias) | High risk | No outcomes were prespecified in the methods; some outcomes reported incompletely in text, e.g. "There was no significant difference between the groups in the use of analgesia, sedatives, and epidural anaesthesia". |
Other bias | Low risk | Appears to be free of other bias. |