Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan

Table 3 Side effects and adverse events by study group*^a

	Misoprostol (800mcg SL) n = 40	Placebo n = 39	RR 95% CI	P value
Shivering	33 (82.5)	24 (61.5)	1.34 (0.98, 1.74)	0.05
Fever	4 (10.0)	7 (17.9)	0.56 (0.14, 1.97)	0.35
Vomiting	6 (15.0)	7 (17.9)	0.84 (0.27, 2.58)	0.72
Fainting	2 (5.0)	1 (2.6)	1.95 (0.14, 54.1)	1.0
Nausea	6 (15.0)	5 (12.8)	1.17 (0.34, 4.19)	0.78
Side effects reported as acceptable ^b	31/35 (88.6)	34/35 (97.1)	0.91 (0.86, 1.06)	0.36
Maternal death	0	1
Neonatal death	0	1

Abbreviations: SL sublingual, RR relative risk, CI confidence interval
* Data are presented as n (%)
^a Among those who received the study treatment, all received 600mcg oral misoprostol as prophylaxis with the exception of 4 women (1 in misoprostol arm; 3 in placebo arm)
^bIn nine cases participants did not report on acceptability of side effects (5 in misoprostol arm; 4 in placebo arm)

ISSN: 1742-4755