A cluster-randomized, non-inferiority trial comparing use of misoprostol for universal prophylaxis vs. secondary prevention of postpartum hemorrhage among community level births in Egypt

Table 3 Side effects reported among women delivering in primary and secondary prevention clusters

	Primary Prevention^a N = 1555	Secondary Prevention^a N = 1099	ICC	Risk ratio^b	95% CI	P value
Shivering	663 (42.6%)	305 (27.8%)	0.33	0.58	0.27–1.24	0.158
Severe	23 (1.5%)	17 (1.6%)
Fever	6 (0.4%)	2 (0.2%)	< 0.01	0.56	0.06–5.25	0.614
Severe	0	0
Diarrhea	3 (0.2%)	1 (0.1%)	< 0.01	0.61	0.05–8.20	0.708
Severe	0	0
Nausea	48 (3.1%)	41 (3.7%)	0.01	1.24	0.60–2.53	0.561
Severe	2 (0.1%)	2 (0.2%)
Vomiting	157 (10.1%)	46 (4.2%)	0.15	0.53	0.18–1.55	0.249
Severe	1 (0.1%)	0
Fainting/feel faint	2 (0.1%)	15 (1.4%)	0.01	10.54	2.34–47.46	0.002
Severe	1 (0.1%)	0
Other^c	22 (1.4%)	5 (0.5%)	0.09	0.28	0.03–2.29	0.236
Severe	2 (0.1%)	0

^aResults are presented as N (%)
^bRisk ratio derived from log-binomial regression incorporating generalized estimating equations (GEE)
^cOther side effects in Group 1: abdominal pain/cramping (n = 18), pain in nipple (n = 1), numbness (n = 2), headache (n = 1) and in Group 2: fatigue (n = 1), cold sweats and low blood pressure (n = 1), chest pain (n = 1), feeling faint (n = 1) and high blood pressure (n = 1)

ISSN: 1471-2393