Jindal 2011 (V50).
Methods | "Identical placebos". Randomised and double‐blind; a coded list indicted which allocation the woman was to receive ‐ the tablets (active and placebo) we then taken from the appropriate 'vial'. | |
Participants | 103 women at term with singleton pregnancies and BS equal or less than 4. All women with ruptured membranes < 4 hours duration. | |
Interventions | Oral or vaginal misoprostol, both 50 mcg 4‐hourly, max 6 doses | |
Outcomes | Labour and delivery outcomes. Neonatal outcomes. |
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Notes | No postrandomisation exclusions. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information about the sequence generation process to permit judgement of ‘Low risk’ or ‘High risk’. |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear whether the allocation was concealed or whether could be seen from the list. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The study did not address this outcome. |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement of ‘Low risk’ or ‘High risk’. |
Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of participants and key study personnel ensured. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of outcome assessment ensured, and unlikely that the blinding could have been broken. "At the end of the study decoding was done according to the decoding list which determined finally which women received active drug misoprostol vaginally and which received orally, accordingly grouped as vaginal or oral for analysis." |