Stitely 2000.
| Methods | RCT. | |
| Participants | Setting: USA, naval medical centre. 50 women. Inclusion criteria: women with prolonged pregnancy (41 to 42 weeks' gestation) confirmed by ultrasound, clinical examination and menstrual dates. Singleton, cephalic presentation, intact membranes, Bishop score < 5, < 8 contractions per h, AFI > 5 cm, reactive NST, maternal age > 18, < 50 years. Exclusion criteria: malpresentations, multiple pregnancy, previous CS, vaginal bleeding, ruptured membranes, non reactive NST, estimated fetal weight > 4500 g or < 2000 g, placenta previa, active herpes, hypersensitivity to prostaglandin, signs of infection, asthma or serious disease. |
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| Interventions | Intervention group: vaginal misoprostol 25 µg (with second dose after 24 h). Comparison group: placebo, packaged and labelled to appear indistinguishable. Both groups were observed for 4 h with FHR and uterine activity monitoring. If women showed no sign of labour of fetal distress they were discharged and asked to return after 24 h for a second dose, then review after a further 24 h for inpatient management. |
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| Outcomes | Uterine hyperstimulation, CS, Apgar score < 7 at 5 min, meconium staining. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated sequence by pharmacy (permuted block design). |
| Allocation concealment (selection bias) | Low risk | The list was maintained by inpatient pharmacy and drugs were dispensed to appear identical. |
| Blinding (performance bias and detection bias) Women | Low risk | Women would not have been aware of assignment; treatment and placebo identical. |
| Blinding (performance bias and detection bias) Clinical staff | Low risk | Investigators and other obstetric staff blind to group assignment. |
| Blinding (performance bias and detection bias) Outcome assessor | Low risk | Outcome assessors not described, but all staff described as blind until analysis completed. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No apparent loss to follow up. |
| Selective reporting (reporting bias) | Unclear risk | Only primary outcome stated in methods text; fetal outcomes not specified. |
| Other bias | Low risk | Baseline demographics comparable. |
AFI: amniotic fluid index AFV: amniotic fluid volume ARM: artificial rupture of membranes CPD: cephalo‐pelvic disproportion CS: caesarean section EDD: expected date of delivery EFW: estimated fetal weight FGR: fetal growth retardation FHR: fetal heart rate GA: gestational age h: hour/s IMN: isosorbide mononitrate ISMN:isosorbide mononitrate IOL: induction of labour ITT: intention‐to‐treat NHS: National Health Service (UK) NICU: neonatal intensive care unit NST: non‐stress test PGE: progesterone PPH: postpartum haemorrhage PROM: premature rupture of the membranes RCT: randomised controlled trial SOL: spontaneous onset of labour