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Table 2 Primary and secondary outcomes

From: Pain management during labor: use of intermittent drug delivery devices for improvement of obstetric and neonatal outcome and reduction of healthcare burden: A large non-inferiority randomized clinical trial

 

TOP-UP (n = 315)

PIEB (n = 313)

p

RR (95% CI)

Instrumental assisted delivery; n (%)

27 (10.5)

36 (13.6)

0.28

1.3 (0.8–2.3)

Cesarean section; n (%)

58 (18.4)

48 (15.3)

0.30

0.8 (0.5–1.2)

Total operative delivery; n (%)

85 (27)

84 (26.8)

0.97

0.99 (0.7–1.4)

NRS average; mean (SD)

4.8 (1.8)

4.0 (1.9)

< 0.0001

 

Parturients with mean NRS < 5; n (%)

146 (47.2)

209 (67.7)

< 0.0001

0.43 (0.3–0.59)

Parturients requiring rescue drug; n; (%)

156 (49.5)

90 (28.8)

< 0.0001

0.4 (0.3–0.6)

Total dose of rescue levobupivacaine; mg, mean (SD)

7.8 (12.3)

2.6 (5.3)

< 0.0001

 

Dose of levobupivacaine per minute of analgesia; mg/min, mean (SD)

0.085 (0.05)

0.099 (0.05)

0.001

 

Total dose of levobupivacaine; mg, mean (SD)

33.4 (22.2)

45.3 (23.9)

< 0.0001

 

Neonatal score

    

0 point, n (%)

258 (81.9)

258 (82.4)

0.988

 

1 point, n (%)

48 (15.2)

45 (14.4)

  

2 points, n (%)

8 (2.5)

8 (2.6)

  

3 points, n (%)

1 (0.3)

2 (0.6)

  
  1. NRS numeric rate scale, IQR interquartile range