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Table 3 Effect measures for the primary outcomes (intention to treat analysis)

From: Safe birth in cultural safety in southern Mexico: a pragmatic non-inferiority cluster-randomised controlled trial

Variable

Absolut event rate

(n)

(cluster n = 40)

RD

95%CIa

OR

95%CIb

ICC

Intervention

Control

   

Any primary outcomesc

0.12

(50/404)

0.18

(85/468)

− 0.06

− 0.09 to − 0.02

0.63

0.42 to 0.95

0.03

Perinatal deaths 2016 and 2017

0.02

(10/404)

0.03

(16/468)

− 0.01

− 0.04 to 0.02

0.73

0.31 to 1.75

0.04

Neonatal complicationsd

0.06

(23/389)

0.07

(39/456)

− 0.04

− 0.08 to 0.01

0.59

0.30 to 1.18

0.05

Childbirth serious problems

0.05

(19/393)

0.08

(35/456)

− 0.05

− 0.08 to − 0.02

0.35

0.14 to 0.92

0.00

Caesarean section

0.13

(50/381)

0.15

(66/441)

−0.03

− 0.10 to 0.04

0.78

0.47 to 1.31

0.11

Perineal trauma or wound infection

0.21

(81/389)

0.21

(94/455)

0.01

−0.07 to 0.08

1.06

0.70 to 1.61

0.07

Perineal trauma or wound infection in home childbirths

0.11

(17/156)

0.24

(27/116)

−0.12

− 0.27 to 0.01

0.40

0.15 to 1.05

0.18

  1. RD risk difference, OR odds ratio, ICC Intra-cluster correlation coefficient
  2. aBaseline-adjusted cluster-level analysis using t-test as presented by Campbell, 2014
  3. bOR and confidence intervals calculated with a GLMM using lme4 package in R
  4. cchildbirth or neonatal complication or perinatal death
  5. d854 women with completed pregnancies reported on childbirth or neonatal complications, and 18 women with completed pregnancies reported only on perinatal deaths