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Table 5 Fetal and neonatal adverse events in the all treated population

From: Recombinant human relaxin versus placebo for cervical ripening: a double-blind randomised trial in pregnant women scheduled for induction of labour

Adverse Event Preferred Term Pooled Placebo (n = 32)a Pooled Serelaxin (n = 40)a
  Number (%) of Fetuses
Tachycardia 2 (6.3) 1 (2.5)
Hypoxia 3 (9.4) 3 (7.5)
  Number (%) of Neonates
Conjunctivitis 4 (12.5) 1 (2.5)
Regurgitation of food 1 (3.1) 3 (7.5)
Cerebral ischemia 8 (25.0) 3 (7.5)
Torticollis 4 (12.5) 2 (5.0)
Hypertonia 3 (8.4) 0 (0.0)
Hypoglycemia 3 (9.4) 2 (5.0)
Jaundice 2 (6.3) 5 (12.5)
Neonatal hypoxia 7 (21.9) 7 (17.5)
Neonatal agitation 7 (21.9) 4 (10.0)
Hypotonia 6 (18.8) 6 (15.0)
Neonatal asphyxia 6 (18.8) 4 (10.0)
Poor weight gain 1 (3.1) 3 (7.5)
Postmature baby 7 (21.9) 1 (2.5)
Umbilical cord around neck 5 (15.6) 3 (7.5)
Dermatitis diaper 3 (9.4) 1 (2.5)
  1. Listed are fetal and neonatal AEs occurring in >5 % in either arm
  2. aThe pooled placebo group includes all fetuses or neonates from Parts A and B treated with placebo and the pooled serelaxin group includes all subjects from Parts A and B treated with any dose of serelaxin