Chanrachkul 2003.
Study characteristics | ||
Methods | RCT | |
Participants | Number of women randomised: 249
Setting: Bangkok, Thailand Study date: study conducted October 1998 to May 2000 Inclusion criteria
Exclusion criteria
State of cervix: favourable (Bishop score 6 or more) |
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Interventions |
Induction group (n = 124): AROM + oxytocin (if uterine contractions inadequate after 2 hours); versus EM group (n = 125): spontaneous labour awaited unless 1) non‐reactive NST or 2) amniotic fluid index < 5 cm or 3) medical or obstetric indication for birth or 4) reaching 44 completed weeks. |
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Outcomes | Mother: prolonged labour; modes of birth and their indications; death; postpartum haemorrhage Baby: perinatal death, birthweight; birth asphyxia, NICU admission, birthweight > 4000 g; Apgar < 7 at 5 minutes | |
Notes |
Funding: Ramathibodi Hospital Research Grant 2/2542 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 | Randomisation was carried out using computer‐generated numbers. |
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 | 1 woman (in IOL group) excluded after randomisation because of misclassification (breech presentation). No apparent losses to follow‐up |
Selective reporting (reporting bias) | Unclear risk | While prespecified outcomes (in the methods) were reported, no access to trial protocol to further assess selective reporting. |
Other bias | Low risk | Appeared to be free of other bias |