Herabutya 1992.
Methods | RCT | |
Participants | Number of women randomised: 108
Setting: Bangkok, Thailand Inclusion criteria
Exclusion criteria
State of cervix: unfavourable cervix (Bishop score 6 or less) |
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Interventions |
Induction group (n = 57): PGE2 intracervical, repeated after 6 hours, AROM and oxytocin on day 2 according to contractions versus Expectant management group (n = 51): a) NST between 42 and 43 completed weeks. 2) NST between 43 and 44 completed weeks; women underwent IOL if there were abnormalities in antepartum fetal testing as non‐reactive NST, or variable decelerations on NST or if Bishop score > 6 on reaching 44 completed weeks' gestation. |
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Outcomes |
Mother: length of first stage of labour; mode of birth; cephalopelvic disproportion; fetal distress Baby: birthweight; meconium staining; Apgar score < 7 at 1 min; Apgar score < 7 at 5 min; intubation required; admission to special care baby unit; perinatal death |
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Notes |
Funding: Ramathibodi Hospital Research Fund Grant 1988 Declaration of interests: 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 | Low risk | No apparent losses to follow‐up or exclusions. |
Selective reporting (reporting bias) | Unclear risk | No outcomes were pre‐specified in the methods; no access to trial protocol to further assess selective reporting. |
Other bias | Low risk | Appears to be free of other bias. |