Table 2.

Outcomes among women delivering in primary and secondary prevention clusters

	N	Primary Prevention1,2	Secondary Prevention1,3	ICC	Estimate4	95% CI	P value5
Non-inferiority test
Hb change	2654	N = 1555	N = 1099
Mean (SD)		−0.37 (0.91)	−0.45 (0.76)	0.16	β = -0.01	Not less than -0.276	0.535
Secondary outcomes
Hb drop ≥2 g/dL	2654	N = 1555	N = 1099
		81 (5.2%)	28 (2.6%)	0.07	RR = 0.46	0.15, 1.37	0.161
Post-delivery Hb	2654	N = 1555	N = 1099
Mean (SD)		10.9 (1.2)	10.8 (1.2)	0.10	β = 0.08	−0.26, 0.42	0.616
PPH diagnosis	2654	N = 1555	N = 1093
		5 (0.3%)	6 (0.6%)	0.02	RR = 2.17	0.28, 16.46	0.455
Transfer to higher level care	2654	N = 1555	N = 1099
		2 (0.1%)	1 (0.1%)	< 0.01	RR = 0.77	0.09, 6.46	0.810
Additional uterotonics7	2654	N = 1555	N = 1099
		4 (0.3%)	2 (0.2%)	0.01	RR = 0.52	0.05, 5.15	0.573

¹Results are presented as N (%) except where otherwise noted

²All 1555 in primary prevention clusters received 600mcg oral misoprostol; 9/1555 (0.6%) women in primary prevention clusters soaked the underpad

³112/1099 (10.2%) women in secondary prevention clusters soaked the underpad; 117 (10.7%) women in secondary prevention clusers received 800mcg misoprostol, including all 112 who soaked the underpad

⁴β Regression coefficient derived incorporating generalized estimating equations (GEE), RR Risk ratio derived from log-binomial regression incorporating generalized estimating equations (GEE)

⁵P value for Hb change is one-sided, all other p values are two-sided

⁶One sided 95% CI for non-inferiority test, pre-defined non-inferiority margin = -0.3

⁷Additional uterotonics administered at place of birth or at the hospital if transferred