Skip to main content

Table 3 Primary and secondary outcomes – feasibility and clinical effectiveness

From: Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial

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