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Table 2 Primary, maternal, and perinatal outcomes (number (percent); median [interquartile range])

From: Halting the Canadian STRIDER randomised controlled trial of sildenafil for severe, early-onset fetal growth restriction: ethical, methodological, and pragmatic considerations

Outcome

Placebo (n = 9)

Sildenafil (n = 11)

P-value*

Primary outcome

 Gestational age at delivery (weeks + days)

29+2 [28+1, 34+1]

26+4 [25+6, 31+0]

0.200

Maternal

 Symptomatic hypotension

0 (0%)

0 (0%)

NA

 Pre-eclampsia

3 (33.3%)

0 (0%)

0.211

 Mode of delivery

0.348

 Termination of pregnancy

1

4

 

 Vaginal birth

0

1

 

 Classical Caesarean section

4

4

 

 Lower segment Caesarean section

4

2

 

 Haemorrhage requiring transfusion

1 (11.1%)

0 (0%)

0.918

Perinatal

 Fetal growth velocity

 Biparietal diameter (mm/days)

0.36 [0.32, 0.49]

0.37 [0.26, 0.39]

0.508

 Head circumference (mm/days)

1.28 [1.03, 2.07]

1.21 [1.04, 1.52]

0.605

 Abdominal circumference (mm/days)

1.05 [0.97, 1.21]

1.37 [1.10, 1.38]

0.310

 Femur length (mm/days)

0.28 [0.20, 0.31]

0.24 [0.16, 0.30]

0.627

 Estimated fetal weight (g/days)

10.80 [6.07, 11.82]

7.19 [5.62, 9.40]

0.667

 Deepest vertical amniotic fluid pocket (mm/days)

0.007 [0.000, 0.009]

0.013 [0.007, 0.070]

0.181

 Stillbirth

1 (11.1%)

4 (36%)

0.436

 Neonatal death

1 (11.1%)

1 (9%)

1

 Intact survival

7 (77.8%)

6 (55%)

0.528

 Persistent pulmonary hypertension of the newborn

0 (0%)

2 (18%)

0.164

  1. * Fisher’s exact (dichotomous) or Mann Whitney U (continuous) test
  2. Defined as survival to estimated due date without evidence of severe central nervous system injury (by ultrasound and/or magnetic resonance imaging)