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. 2023 Mar 30;2023(3):CD001233. doi: 10.1002/14651858.CD001233.pub4

Ahmed 2016.

Study characteristics
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
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
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
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