Primary and Secondary outcomes: Clinical effectiveness | Foley Catheter (N = 50) | PGE2 Gel (N = 51) | Odds ratio or mean difference (95% CI) | P-value |
---|---|---|---|---|
Primary outcomes | ||||
Vaginal delivery within 12 hours of admission to Birthing unit | 14 (28%) | 27 (53%) | .35 (.15–.79) | .011 |
Inpatient hours randomisation to birth | 21.3 (+/−10.1) | 32.4 (+/−16.9) | −11.3 (−5.9 to −16.7) | <.001 |
Secondary outcomes | ||||
Mode of Delivery | .116 | |||
· Vaginal Delivery | 33 (66%) | 36 (71%) | .85 (.35-1.87) | .620 |
◦ Normal Vaginal Delivery | 15 (30%) | 25 (49%) | .051 | |
◦ Instrumental Delivery | 18 (36%) | 11 (22%) | 2.0 (0.85-4.9) | .109 |
· Caesarean Section | 17 (34%) | 15 (29%) | .620 | |
Delivery Suite hours prior to birth | 13.9+/−(7.5) | 9.7+/−(5.1) | .001 | |
Require Oxytocin | 44 (88%) | 30 (59%) | 5.1 (1.9–14.2) | .001 |
· Duration - Oxytocin (Hrs) | 11.6+/−(6.0) | 9.0+/−(3.6) | .035 | |
· Max Concentration – Oxytocin | 53.7+/−(25.7) | 45+/−(23.7) | .155 | |
Duration (Hrs) | ||||
· Cervical Ripening to Admission to Birthing unit | 19.2+/−(7.0) | 21.7+/−(19.2) | .245 | |
· Cervical Ripening to Delivery Interval | 33.5+/−(11/2) | 31.1+/−(16.3) | .402 | |
Cervical ripening to vaginal delivery interval: | ||||
Vaginal Delivery within 24 Hours | 6 (12%) | 15 (29%) | .33 (.12–.93) | .031 |
Vaginal Delivery beyond 24 Hours | 27 (54%) | 21 (41%) | .197 | |
Outcome of cervical preparation | .27 | |||
· Requirement for 3rd dose PGE2 (IP) | 6 (12%) | |||
· Crossover to PGE2 for failed Foley (OPC) | 2 (4%) | |||
Total inpatient stay (hours) | 96+/−38 | 105+/−38 | −9 (−24 to 7) | .267 |