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

Table 4 Maternal adverse events

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)

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
^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

ISSN: 1471-2393