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Table 2 Outcomes among women delivering in primary and secondary prevention clusters

From: 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

 

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

  1. 1Results are presented as N (%) except where otherwise noted
  2. 2All 1555 in primary prevention clusters received 600mcg oral misoprostol; 9/1555 (0.6%) women in primary prevention clusters soaked the underpad
  3. 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
  4. 4β Regression coefficient derived incorporating generalized estimating equations (GEE), RR Risk ratio derived from log-binomial regression incorporating generalized estimating equations (GEE)
  5. 5P value for Hb change is one-sided, all other p values are two-sided
  6. 6One sided 95% CI for non-inferiority test, pre-defined non-inferiority margin = -0.3
  7. 7Additional uterotonics administered at place of birth or at the hospital if transferred