Sharma 2005.
Methods | 'Randomised' Inpatient setting. Recruitment between November 2001 and November 2003, Deptartment of Obstetrics and Gynecology, at the All India Institute of Medical Sciences, New Delhi. | |
Participants | Women scheduled for admission for cervical ripening and labour induction. Inclusion criteria: included all of the following: nulliparity, singleton fetus, modified Bishop score < 6. Exclusion criteria: previous caesarean section and ruptured membranes. |
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Interventions | 65 were randomised into 3 groups. 21 were prescribed 500 mcg GTN (misoprostol) tablets, 21 received 0.5 mg intracervical PGE2 and 23 received 50 mcg of vaginal misoprostol. Women were reassessed at 6 hours and if possible amniotomy was performed. If Bishop score < 6 then further dose of same drug was given. |
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Outcomes |
Maternal: uterine hyperstimulation with and without FHR changes, caesarean section, cervix unfavourable at 12 to 24 hours, oxytocin augmentation, instrumental vaginal delivery and maternal side effects (headache). Neonatal: perinatal death, serious neonatal morbidity or death. |
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Notes | 2 patients (1 from GTN and 1 from misoprostol group excluded due to being delivered by caesarean section after first dose of medication. Not clear if included in final data on caesarean section. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomised." |
Allocation concealment (selection bias) | Unclear risk | No details given. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | May be concern over 2 post randomisation exclusions. |
Selective reporting (reporting bias) | Low risk | No evidence to the contrary. |
Other bias | Unclear risk | No evidence to the contrary. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated. |