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. 2009 Oct 7;2009(4):CD003246. doi: 10.1002/14651858.CD003246.pub2

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.
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.
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.