Dyson 1987.
Study characteristics | ||
Methods | RCT | |
Participants | Number of women randomised: 302
Setting: Kaiser Permanente Medical Care Hospital in California, USA Study date: study conducted 11 January 1983 to 3 December 1985 Inclusion criteria
Exclusion criteria
State of cervix: unfavourable (Bishop score < 6) |
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Interventions |
Induction group (n = 152): PE2 gel (initially 3 mg but later reduced to 0.5 mg). If no labour in 24 hours, repeat PE2 and oxytocin if needed versus EM group (n = 150): NST twice weekly, pelvic examination and amniotic fluid determination weekly between 41‐42 weeks and twice weekly afterwards |
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Outcomes |
Mother: length of hospital stay; caesarean section; length of labour Baby: perinatal death; 1 minute Apgar score < 7; 5 minute Apgar score < 7; meconium‐stained amniotic fluid; meconium aspiration syndrome; post‐maturity syndrome; fetal distress; birthweight; birthweight > 4000 g; infant hospital stay length |
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Notes |
Funding: Community Service Program of Kaiser Foundation Hospitals 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 | A table of random numbers was used. |
Allocation concealment (selection bias) | Unclear risk | The authors reported " using a series of consecutively numbered, sealed envelopes..." for allocation concealment, but no mention was made of envelope opaqueness. |
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 apparent losses to follow‐up or exclusions |
Selective reporting (reporting bias) | Unclear risk | No outcomes were prespecified in the methods; no access to trial protocol to further assess selective reporting |
Other bias | Low risk | Appeared to be free of other bias |