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Table 3 Secondary outcomes after randomization to eye-mask and earplugs or headband

From: Eye-masks and earplugs compared to headband in nulliparas on increasing spontaneous vaginal delivery: a randomized trial

Outcomes

Eye-mask-earplugs

n = 117

Headband

n = 117

RR (95% CI)

NNTb (95% CI)

P value

Night sleep duration (hours): self-reported

7.0 ± 1.2

6.6 ± 1.5

  

0.04

Participants’ satisfaction with sleep aida

7 [6.0–8.0]

6 [5.0–7.5]

  

 < 0.001

Slept better with sleep aid

 Agreeb

87 (74.4%)

48 (41.0%)

1.81(1.42–2.30)

NNTb 4 (2.2–4.7)

 < 0.001

 Do not agreeb

30 (25.6%)

69 (59.0%)

   

Compliance

 Sleep aid use (times per week)

5 [3.0–7.0]

4 [2.0–5.0]

  

0.002

 Did not use sleep aid (0 times per week)

1 (0.9%)

9 (7.7%)

0.11(0.01–0.86)

NNTb 15 (8.4–57.8)

0.02 g

Maternal outcomes

 Gestational age at delivery (weeks)

38.6 ± 1.2

38.6 ± 1.3

  

0.91

 Preterm birth < 37 weeks

7 (6.0%)

9 (7.7%)

0.78(0.30–2.02)

 

0.80 g

 Recruitment to delivery interval (weeks)

3.5 ± 1.4

3.5 ± 1.6

  

0.92

 Estimated blood loss during delivery (ml)

350 [300–400]

400 [300–550]

  

0.25

 Induction of labor

50 (42.7%)

49 (41.9%)

1.02(0.76–1.38)

 

1.00

 Indications for induction

(n = 50)

(n = 49)

  

0.02

 Small for gestational age

14 (28.0%)

11 (22.4%)

   

 Gestational diabetes

17 (34.0%)

10 (20.4%)

   

 Gestational hypertension

1 (2.0%)

6 (12.2%)

   

 Pre-labor rupture of membrane

5 (10.0%)

1 (2.0%)

   

 Large for gestational age

3 (6.0%)

5 (10.2%)

   

 Prolonged pregnancy

2 (4.0%)

11 (22.4%)

   

 Othersc

8 (16.0%)

5 (10.2%)

   

Methods of induction

 Amniotomy

27 (23.1%)

23 (19.7%)

  

0.95

 Mechanical (Foley’s catheter)

42 (35.9%)

46 (39.3%)

   

 Prostaglandins

4 (3.4%)

3 (2.6%)

   

 Oxytocin

11 (9.4%)

12 (10.3%)

   

Analgesia use in labor

 Epidural

31 (26.5%)

34 (29.1%)

  

0.85

 Pethidine

8 (6.8%)

11 (9.4%)

   

 Entonox alone

10 (8.5%)

12 (10.3%)

   

 Entonox & pethidine

37 (31.6%)

31 (26.5%)

   

Neonatal outcomes

Birthweight (kg)

2.91 ± 0.38

2.94 ± 0.40

  

0.55

 

n = 116d

n = 117

   

 Apgar score at 1-min Score ≥ 4

9 [9–9]

116 (100%)

9 [9–9]

117 (100%)

  

0.02

.e

 Apgar score at 5-min Score ≥ 7

10 [10–10]

116 (100%)

10 [10–10]

117 (100%)

  

0.06

.e

 

n = 107

n = 109

   

 Umbilical cord arterial blood pH

7.29[7.21–7.34]

7.31[7.25–7.34]

  

0.49

 Neonatal admission

9 (7.7%)

11 (9.4%)

  

0.82

 Indications for neonatal admission

(n = 9)

(n = 11)

   

Infant of diabetic mother

1 (0.9%)

   

0.48

 Transient tachypnea of newborn

5 (4.4%)

7 (6.1%)

   

 Presumed sepsis

2 (1.7%)

2 (1.7%)

   

 Low birthweight

 

1 (0.9%)

   

 Othersf

1 (0.9%)

1 (0.9%)

   
  1. Data expressed as mean ± standard deviation, median [interquartile range] or number (%). Analyses by Student t test for continuous data, Chi Square test for categorical datasets (Fisher exact test if > 20% of cells evaluated have cell value < 5) and Mann Whitney U test for non-parametric data (assessed by Kolmogorov–Smirnov test) or ordinal data. 2-sided P < 0.05 for all variables
  2. a11-point visual numerical rating score (VNRS), with 0 representing completely dissatisfied and 10 representing completely satisfied
  3. bRecategorization of Likert scale responses: “agree” includes strongly or somewhat agree; “Do not agree” includes neither agree nor disagree, somewhat disagree and strongly disagree
  4. cOther indications: 6 for non-reassuring fetal status, 2 for prolonged latent phase of labor, 2 for indeterminate antepartum hemorrhage, 3 for maternal medical condition
  5. dOne participant delivered in private center had no neonatal outcome data
  6. e No statistics are computed because the score ≥ 4 and ≥ 7 are constant
  7. f Other indications: 1 for infant of retroviral positive mother and 1 for infant with cleft lip and palate
  8. gFisher’s exact test