Methods | RCT, placebo controlled trial. | |
Participants | Setting: not clear. 36 women. Inclusion criteria: healthy, nulliparous women, 41 weeks’ gestation and Bishop score < 9 |
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Interventions | Intervention group: 2.5 mg intravaginal PGE2, with 2nd dose if labour not established 24 hrs later Comparison group: placebo gel, with 2nd dose after 24 hrs if labour was not established |
|
Outcomes | Change in cervix after 48hrs. | |
Notes | Information from brief abstract. | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Described as “randomized”. |
Allocation concealment? | Unclear | No information. |
Blinding? Women |
Yes | Described as double-blind trial with placebo gel. |
Blinding? Clinical staff |
Yes | |
Blinding? Outcome assessor |
Unclear | No information. |
Incomplete outcome data addressed? All outcomes |
Unclear | Little information on methods. It appeared that all women were available at follow up |