Egarter 1989.
Study characteristics | ||
Methods | RCT | |
Participants | Number of women randomised: 345
Setting: Vienna, Austria Study date: not reported Inclusion criteria
Exclusion criteria
State of cervix: favourable (Modified Bishop score > 4) |
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Interventions |
Induction group (n = 180): vaginal PE2 (3 mg) tablets repeated 6 and 24 hours later if no active labour versus EM group (n = 165): spontaneous labour awaited until 42 weeks. NST monitoring every 2‐3 days |
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Outcomes |
Mother: birth interval (onset of contractions to birth in hours); rate and indication for operative birth; length of labour; analgesia requirements; caesarean section Baby: birthweight; length of baby at birth; incidence of meconium‐stained amniotic fluid; Apgar scores; results of umbilical cord pH determination; perinatal death |
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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) | Unclear risk | The method of sequence generation was not reported. |
Allocation concealment (selection bias) | Unclear risk | The method of allocation concealment was not reported. |
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 | Unclear risk | 8/180 women in the induction group refused to be induced; and 3/165 women in the expectant group requested induction; and these 11 women were excluded from analysis post‐randomisation. |
Selective reporting (reporting bias) | High risk | No outcomes were prespecified in the methods, limited information was provided for some outcomes, e.g. "The incidence of prolonged labor was not different in both groups... both groups required analgesic treatment in 35%... Birthweight and length, the incidence of meconium‐stained amniotic fluid, of low Apgar scores, and the results of pH determination were not different between the two groups." |
Other bias | Unclear risk | Some imbalance in the numbers randomised to each group (180 versus 165) |