Parikh 2001.
Methods | RCT. | |
Participants | 30 women attending for induction for a range of indications including post‐dates and IUGR. Inclusion criteria: singleton pregnancy, term, cephalic presentation, intact membranes, Bishop score < 4. Exclusion criteria: previous C/S, sensitivity to prostaglandins, fetal distress, any medical condition such as heart disease, asthma or glaucoma. |
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Interventions | IV oxytocin. Initial dose 5 mU/min increasing by 5 mU/min until 4 sustained contactions in 10 mins. At 3 ‐ 4 cms cervical dilatation amniotomy performed and IV oxytocin continued. FHR closely monitored vs intracervical prostaglandin (PGE2 gel). Examination after 6 hours to assess Bishop score. If score did not exceed 6 then 2nd dose. If score above 6 then amniotomy and later augmentation with IV oxytocin if required. FHR monitored. |
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Outcomes | CS, fetal distress, time from induction to onset of labour, time to delivery. Successful induction. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Described as "patients randomly assigned". |
Blinding? Women | High risk | Not feasible. Different treatment protocols. |
Blinding? clinical staff | High risk | |
Blinding? outcome assessor | High risk | |
Incomplete outcome data addressed? All outcomes | Low risk | No apparent loss to follow up. |
Free of other bias? | Unclear risk | Small study without the power to detect differences between groups for main outcomes. |