Table 3 Effect of the intervention on maternal, perinatal and neonatal health outcomes

From: Effects of the WHO Labour Care Guide on cesarean section in India: a pragmatic, stepped-wedge, cluster-randomized pilot trial

 

Intervention period (N = 14,814 women)

Control period (N = 11,517 women)

RR (95% CI)a

n/N

(%)

n/N

(%)

 

Maternal secondary outcomes

     

Third- or fourth-degree tears

18/14,814

(0.12)

25/11,517

(0.22)

0.51 (0.01–29.16)

Postpartum hemorrhage requiring uterine balloon tamponade or surgical intervention

28/14,814

(0.19)

46/11,517

(0.40)

0.38 (0.00–84.07)

Suspected or confirmed maternal infection requiring therapeutic antibiotics

114/14,814

(0.77)

53/11,517

(0.46)

2.12 (0.06–70.96)

Fetal/neonatal secondary outcomes

     

Stillbirth

449/14,971

(3.00)

367/11,624

(3.16)

0.97 (0.43–2.19)

Antepartum stillbirth

279/14,971

(1.86)

286/11,624

(2.46)

0.91 (0.34–2.47)

Intrapartum stillbirth

163/14,971

(1.09)

79/11,624

(0.68)

0.90 (0.49–1.65)

Apgar score <7 at 5 minutes

670/14,522

(4.61)

567/11,257

(5.04)

1.17 (0.86–1.59)

Bag and mask ventilation of newborn

424/14,522

(2.92)

256/11,257

(2.27)

1.21 (0.08–18.75)

Mechanical ventilation of newborn

293/14,522

(2.02)

260/11,257

(2.31)

1.29 (0.36–4.66)

Prolonged (>48 hour) admission in NICU

1,843/14,522

(12.7)

1,014/11,257

(9.0)

1.14 (0.47–2.79)

Newborns requiring NICU admission for hypoxic ischemic encephalopathy

34/14,522

(0.23)

152/11,257

(1.35)

0.40 (0.04–3.74)

Composite neonatal morbidity outcomeb

376/14,522

(2.59)

377/11,257

(3.35)

1.11 (0.32–3.79)

Neonatal death

200/14,522

(1.38)

196/11,257

(1.74)

1.31 (0.37–4.71)

Perinatal death (stillbirth or neonatal death)

649/14,971

(4.34)

563/11,624

(4.84)

1.06 (0.41–2.73)

  1. aThe RR and 95% CI were estimated with the generalized estimating equation method employing the Manck and DeRouen bias correction method and a degree of freedom approximation.
  2. bThe composite neonatal outcome was defined as one or more of the following: mechanical ventilation of the newborn, requirement of NICU admission for hypoxic ischemic encephalopathy of the newborn or neonatal death.