Skip to main content

Table 5 Pregnancy outcomes, perinatal mortality, and neonatal mortality (number (%) unless otherwise stated)

From: Statistical analysis plan for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2)

 

CHAMPION2 intervention arm

STRIPES2 intervention arm

Risk ratio

Intention to treat

   

Pregnancy outcome

   

 Total

x

x

 

 Stillbirth

x (x)

x (x)

 

 Livebirth

x (x)

x (x)

 

 Unknown

x (x)

x (x)

 

Outcome of livebirths at 28 days

   

 Total

x (x)

x (x)

 

 Neonatal death

x (x)

x (x)

 

  Neonatal death on day of birth (day 0)a

x (x)

x (x)

 

  Neonatal death between 1 and 2 days

x (x)

x (x)

 

  Neonatal death between 3 and 6 days

x (x)

x (x)

 

  Neonatal death between 7 and 27 days

x (x)

x (x)

 

 Survived to 28 days

x (x)

x (x)

 

 Unknown

x (x)

x (x)

 

Stillbirth rate (stillbirths per 1000 births), ignoring those with unknown status in the denominator

x 

x 

xb

(95% CI: x, x)

Perinatal death rate (deaths per 1000 births), ignoring those with unknown status in the denominatorc

x

x

xb

(95% CI: x, x)

Neonatal mortality rate (deaths per 1000 live births), ignoring those with unknown status in the denominatord

x

x

xb

(95% CI: x, x)

Place of birth for babies who died

   

 Home

x (x)

x (x)

 

 Hospital/health centre

x (x)

x (x)

 

 On the way to hospital

x (x)

x (x)

 

 Relatives’ home

x (x)

x (x)

 

Primary cause of deathe

   

 Congenital anomaly

x (x)

x (x)

 

 Birth asphyxia

x (x)

x (x)

 

 Preterm newborn

x (x)

x (x)

 

 Sepsis of newborn

x (x)

x (x)

 

 Others

x (x)

x (x)

 

 Unknown

x (x)

x (x)

 

Per-protocol

   

Pregnancy outcome

   

 Total

x

x

 

 Stillbirth

x (x)

x (x)

 

 Livebirth

x (x)

x (x)

 

 Unknown

x (x)

x (x)

 

Livebirths at 28 days

   

 Total

x (x)

x (x)

 

 Neonatal death

x (x)

x (x)

 

  Neonatal death on day of birth (day 0)a

x (x)

x (x)

 

  Neonatal death between 1 and 2 days

x (x)

x (x)

 

  Neonatal death between 3 and 6 days

x (x)

x (x)

 

  Neonatal death between 7 and 27 days

x (x)

x (x)

 

 Survived to 28 days

x (x)

x (x)

 

 Unknown

x (x)

x (x)

 

Neonatal mortality rate (deaths per 1000 live births), ignoring those with unknown status in the denominatord

x

x

xb

(95% CI: x, x)

  1. aNote that the date of birth is day 0
  2. bFrom a generalised linear model for a binary outcome with a log link and robust Huber-White standard errors that allow for clustering, with randomisation stratification variables as covariates. See the “Analysis methods” section for details
  3. cNumerator is sum of stillbirths and neonatal deaths within 7 days; denominator is sum of stillbirths, neonatal deaths, and those surviving to 28 days
  4. dNumerator is neonatal deaths; denominator is sum of neonatal deaths and those surviving to 28 days
  5. eFull list of causes to be determined from ICD-11 classification/codes
Back to article page

Trials

ISSN: 1745-6215