Valadan 2005.
Methods | RCT. | |
Participants | 91 women attending for induction indicated by post‐dates. Inclusion criteria: singleton pregancy, cephalic presentation, intact membranes on admission, aged 16‐45 years, reassuring FHR, no more than 2 contactions in a 10‐minute period, Bishop score < or = 4. Exclusion criteria: uterine scar after previous C/S, contraindication to vaginal delivery, vaginal bleeding, ruptured membranes, unstable pre‐eclampsia, suspected chorionamnionitis, contraindication to prostaglandin. |
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Interventions | Both groups had routine amniotomy as early as possible after admission. IV oxytocin. 6 mU/min increasing by 6 mU/min at 40 min intervals to max dose of 42 mU/min, unless signs of fetal distress or hyperstimulation vs intravaginal dinoprostone (PGE2) tablet. After 6 hrs Bishop score evaluated if less than 3 contractions per 10 mins then IV oxytocin started at same dose as above. |
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Outcomes | Primary outcome: delivery within 24 hrs. | |
Notes | Mean length of labour stated but not clear how many women delivered within 24 hours. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Described as "stratified randomisation technique". |
Allocation concealment? | Unclear risk | Not stated. |
Blinding? Women | High risk | Not feasible. |
Blinding? clinical staff | High risk | |
Blinding? outcome assessor | High risk | |
Incomplete outcome data addressed? All outcomes | Low risk | |
Free of selective reporting? | Unclear risk | Not clear how many women delivered within 24 hours (this was stated as the primary outcome). |