Pregnancy Outcomes Study
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Determining the cause of deaths among preterm births (both live births and stillbirths)
- Registration Number
- CTRI/2018/03/012281
- Lead Sponsor
- Bill and Melinda Gates Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Pregnant women > 18 years of age
Women who are admitted likely to have a preterm delivery (20-37 weeks gestation) or women who have a known stillbirth (intrauterine fetal death >20 weeks).
Preterm infants who are admitted to the NICU at <7 days of age
Exclusion Criteria
Induced (medical) abortion
Unable to determine the gestational age at delivery
Gestational age < 20 weeks at delivery
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of this study is cause of deaths in preterm births, which will be defined as delivery at or after 20 0/7 weeks and prior to 37 0/7 weeks, and in stillbirthsTimepoint: Enrollment to 28 days of neonatal age
- Secondary Outcome Measures
Name Time Method To determine the placental pathology associated with stillbirth and preterm deathsTimepoint: Enrollment to 28 days of life;To evaluate the rate of mortality by gestational age and birth weightTimepoint: Enrollment to 7 days of life;Interventions associated with reduced risk of mortality among preterm births or stillbirthTimepoint: Enrollment to 28 days of life;Obstetric risk factors for stillbirth and neonatal mortalityTimepoint: Enrollment to delivery;To determine causes among extremely preterm (28 weeks) very preterm (28-32 weeks) preterm (32-37 weeks) in relation to the cause of deathTimepoint: Enrollment to 28 days of life;To determine the pathogens associated with stillbirth and preterm deathsTimepoint: Enrollment to 28 days of neonatal age