Chanrachakul 2002.
Methods | Randomly allocated by computer‐generated number. Inpatient setting. Recruitment between December 1999 and September 2000 in Ramathibodi Hospital, Mahidol University, Thailand. | |
Participants |
Inclusion criteria: singleton pregnancy, cephalic presentation, Bishop score < 6, reactive non‐stress test. Exclusion criteria: fetal malpresentations. contraindications to receive nitric oxide donors or prostaglandins. |
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Interventions | 110 women randomised, 107 analysed. 55 women received vaginal ISMN tablet (40 mg) versus 52 women who received vaginal misoprostol (50 µg). Both groups reviewed at 6, 12 and 24 hours. At 24 hours (or earlier if possible) both groups had forewater amniotomy and oxytocin. |
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Outcomes |
Maternal: uterine hyperstimulation both with and without FHR changes, caesarean section, cervix unfavourable/unchanged after 12 to 24 hours, oxytocin augmentation, maternal nausea or headache and postpartum haemorrhage. Neonatal: Apgar score < 7 at 5 minutes, NICU admission. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated. |
Allocation concealment (selection bias) | Unclear risk | No details given. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 sets of incomplete data and 1 woman withdrawn due to an undiagnosed breech presentation. |
Selective reporting (reporting bias) | Low risk | No evidence to the contrary. |
Other bias | Low risk | No evidence to the contrary. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No mention of suitable dummies used. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor not aware of treatment allocation. |