Perche 2009.
Methods | Double‐blind randomised controlled trial (setting unclear). Recruitment period not stated, at Urquinana Central Hospital, Maracaibo, Zuilia State, Venezuela. | |
Participants | Women scheduled for admission for cervical ripening and labour induction. Inclusion criteria: included all of the following: singleton fetus, term pregnancies, modified Bishop score < 6, and not in labour. Exclusion criteria: Bishop score > 7, ruptured membranes, chorioamnionitis, bleeding. |
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Interventions | 60 were randomised. 30 were prescribed 40 mg ISMN tablets and 30 received 50 mcg vaginal misoprostol. These medications were repeated every 4 hours for 24 hours. no further details of subsequent treatments were given. | |
Outcomes | Oxytocin augmentation, Apgar score < 7 at 5 minutes, maternal side effects. | |
Notes | Original trial report in Spanish and translated prior to extraction. The authors are grateful to Luciana Figuera for her translation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number tables. |
Allocation concealment (selection bias) | Low risk | Sealed envelopes. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Limited reporting unable to make judgement. |
Selective reporting (reporting bias) | Unclear risk | Limited reporting unable to make judgement. |
Other bias | Unclear risk | Limited reporting unable to make judgement. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Limited reporting unable to make judgement. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Limited reporting unable to make judgement. |