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Table 4 Maternal adverse events

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

Observation Period
Adverse Event Preferred Term
Number (%) of Subjects
  Pooled Placebo (n = 32)a Pooled Serelaxin (n = 40)a
Study Drug Dosing
 Tachycardia 4 (12.5) 2 (5.0)
24-h Post-infusion
 Amniotic fluid decreased 3 (9.4) 0 (0.0)
 Labour complication 3 (9.4) 0 (0.0)
 Post-partum vaginal laceration 3 (9.4) 2 (5.0)
 Uterine cervical laceration during labour 4 (12.5) 2 (5.0)
 Uterine hypotonus 2 (6.3) 3 (7.5)
>48-h Post-infusion (follow-up)
 Amniotic fluid decreased 4 (12.5) 3 (7.5)
 Uterine cervical laceration during labour 6 (18.8) 4 (10.0)
 Uterine hypotonus 2 (6.3) 3 (7.5)
 Uterine hemorrhage 3 (9.4) 0 (0.0)
  1. Listed are all adverse events occurring in >5 % in either arm during study drug dosing, within the 24-h post-infusion period and within the follow up period
  2. aThe pooled placebo group includes all subjects 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