Rameez 2007.
Methods | Double‐blind randomised controlled trial (stratified by parity) in an inpatient setting. Recruitment between August 2003 and April 2004 at the University Obstetric Unit, Teaching Hospital, Galle, Sri Lanka. | |
Participants | Women scheduled for admission for cervical ripening and labour induction. Inclusion criteria: included all of the following: uncomplicated singleton fetus, cephalic presentation, ≥ 41 completed weeks' gestation, modified Bishop score < 5. Exclusion criteria: any medical or obstetric problems or contraindications to ISMN. |
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Interventions | 156 were randomised. 78 were prescribed 60 mg ISMN tablets and 78 received placebo (vitamin C) re‐examined after 48 hours. If cervix favourable (Bishop score ≥ 7) then they were induced the same day with amniotomy and oxytocin. if unfavourable then an intracervical extra amniotic Foley catheter was used to induce further ripening. |
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Outcomes | Maternal: caesarean section, additional induction agents used. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Block randomisation (stratified by parity). |
Allocation concealment (selection bias) | Low risk | Sealed, opaque sequentially numbered envelopes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence to the contrary. |
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 | Low risk | Outcome assessor unaware of allocation. Suitable dummies used so patient blinded as well. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor unaware of allocation. Suitable dummies used so patient blinded as well. |