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Table 3 Secondary outcomes after randomization to speculum or digital insertion of Foley catheter for the induction of labour in nulliparous women with unripe cervixes

From: Speculum versus digital insertion of Foley catheter for induction of labor in Nulliparas with unripe cervix: a randomized controlled trial

Secondary outcomes

Digital (n = 42)

Speculum (n = 44)

RR (95% CI)

P value

Fidelity to allocated insertion technique

29 (69)

32 (73)

0.9 (0.7–1.2)

0.71**

Use of additional method(s) for ripening

3 (7)

1 (2)

3.1 (0.3–29.0)

0.28**

Insertion-to-balloon expulsion or removal interval (hours)

17.0 ± 5.7

15.7 ± 7.1

 

0.34*

Epidural analgesia

8 (19)

7 (16)

1.2 (0.5–3.0)

0.70**

Oxytocin for labor

34 (81)

36 (82)

1.0 (0.8–1.2)

0.92**

Induction to delivery interval (hours)

30.7 ± 9.4

29.6 ± 11.5

 

0.64*

Mode of delivery

   

0.285**

 Spontaneous vaginal

15 (36)

12 (27)

  

 Operative vaginala

2 (5)

4 (9)

  

 Cesarean sections

25 (60)

28 (64)

0.9 (0.7–1.3)

0.7**

Indication for operative vaginal

   

0.22

 Non-reassuring fetal status

0 (0)

2 (50)

  

 Failure to progress

2 (100)

2 (50)

  

Indications for Cesarean delivery

  

1.1 (0.5–2.8)

0.81**

 Non-reassuring fetal status

7 (28)

7 (25)

  

 Failure to progress

18 (72)

21 (75)

  

Postpartum outcomes

 Delivery blood loss (ml)

300 [250–500]

350 [250–500]

 

0.95***

 Postpartum hemorrhage (≥500 ml)

12 (29)

12 (27)

1.0 (0.5–2.1)

0.89**

 Induction to discharge interval (days)

3.3 ± 0.9

3.4 ± 1.2

 

0.66*

 Maternal satisfaction (induction to birth)

7 [6–8]

7 [7–8]4

 

0.97***

 Feverb

2 (5)

1 (2)

2.1 (0.2–22.3)

0.53**

Neonatal outcomes

 Birth weight (kg)

2.94 ± 0.43

2.95 ± 0.45

 

0.87*

 Apgar score at 5 min

10 [10–10]

10 [10–10]

 

0.13***

 Apgar score at 5 min < = 6

0 (0)

0 (0)

  

 Apgar score at 1 min

9 [9–9]

9 [9–9]

 

0.27***

 Apgar score at 1 min ≤ 4

0 (0)

0 (0)

  

 Admission to neonatal unitc

5 (12)

6 (14)

0.9 (0.3–2.6)

0.81**

Indication for admission

 Transient tachypnea

1 (25)

1 (17)

  

 Severe neonatal jaundice

1 (25)

   

 Presumed sepsis

1 (25)

1 (17)

  

 Observe for heart block

 

1 (17)

  

 Hypoglycemia

 

1 (17)

  

 Grunting

1 (25)

   

 Congenital pneumonia

1 (25)

   

 Mild bilateral ventriculomegaly

 

1 (17)

  

 Meconium aspiration syndrome

 

1 (17)

  

Umbilical cord artery blood pH

7.3 ± 0.06

7.3 ± 0.06

 

0.19*

 pH ≤ 7.1

0 (0)

0(0)

  

Umbilical cord artery blood base excess

−4.7 ± 2.9

−5.1 ± 3.2

 

0.50*

 Base excess ≤ −8

6 (14)

7 (16)

 

0.84**

  1. Data are represented as mean ± standard deviation, number (%) or median [interquartile range]. * represents analyses by t test for means, ** represents Chi Square test for categorical data and *** represents Mann-Whitney U test for ordinal data
  2. aOperative vaginal includes forceps and vacuum. For the digital arm, forceps delivery n = 2 while for the speculum arm, forceps delivery n = 1, vacuum delivery n = 3
  3. bFever is temperature greater than or equal to 38 degrees is recorded intrapartum or 1 day postpartum
  4. cThis includes special care nursery, neonatal intensive care unit and pediatric wards