Ahmed 2016.
Methods | RCT | |
Participants | Inclusion: postdate pregnancy (> 40 weeks) singleton gestation, intact membranes, cephalic fetal BS ≤ 4 Exclusion: previous caesarean deliveries, EFW > 4000 g, non‐reassuring fetal conditions, ruptured membranes, placenta previa, malpresentation |
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Interventions | Foley catheter (n = 39), 18 F, filled with 50 mL Cook balloon (n = 39), filled with 80/80 mL Max of 12 hours of priming |
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Outcomes | Cervical ripening and BS after 12 hours, VAS for catheter insertion, catheter insertion (easy, moderate or difficult), VAS for patient satisfaction after birth, insertion expulsion time, insertion amniotomy time, insertion delivery time and mode of delivery. Abnormal fetal presentation, cord prolapse, bleeding related to catheter insertion that required removal of the catheter and AS | |
Notes | Setting: Gynaecology, Suez Canal University
Hospital, Egypt Study period: March 2013 to April 2014 Funding: not mentioned Declaration of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Shuffling 78 envelopes, 1:1 |
Allocation concealment (selection bias) | Low risk | Sealed envelopes, opaque? |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not feasible due to nature of intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | ITT not mentioned, 2 women excluded because of failed placement. no missing data mentioned |
Selective reporting (reporting bias) | High risk | Pre‐specified outcomes bleeding after insertion, cord prolapse and abnormal fetal presentation not described in results |
Other bias | Low risk | No other bias detected |