Asia Pregnancy Outcomes Study
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|ClinicalTrials.gov Identifier: NCT03438110|
Recruitment Status : Enrolling by invitation
First Posted : February 19, 2018
Last Update Posted : September 10, 2019
Preterm birth is a major cause of child mortality and morbidity, most of which occurs in south-east Asia and sub-Saharan Africa. To date few neonatal cause of death studies, especially in low- and middle-income countries have determined the specific causes of preterm death, instead attributing all neonatal deaths of infants born at less than 37 weeks to prematurity. Infections are responsible for a large proportion of these deaths but because of complexity and costs associated with testing, little is known about the prevalence of infection-related deaths in preterm infants or the specific pathogens associated with mortality.
The primary objective of this study is to determine the cause of deaths among preterm births and stillbirths. Secondary outcomes include determining the specific pathogens responsible for infection-related deaths, potential preventability of these deaths and interventions which may reduce mortality. One site in India and one in Pakistan will include a total sample size of 700 (350 stillbirths and 350 preterm neonatal deaths) for 1,400 cases to be included in the cause of death analyses. All women who deliver a preterm birth or a stillbirth at the study hospitals will be eligible for inclusion. Among those who consent, an obstetric history, clinical obstetric and (if applicable) neonatal care will be collected as well as research investigations including ultrasound, x-ray, microbiology and minimally invasive tissue sampling and autopsy will be collected.
This study will align with other efforts to determine cause of death among infants and children and ultimately the results will inform future interventions to reduce neonatal mortality and stillbirth. The researchers emphasize that this study, with its focus on preterm neonatal mortality and stillbirth, will provide information not available elsewhere.
|Condition or disease|
|Neonatal Death Stillbirth|
|Study Type :||Observational|
|Estimated Enrollment :||1400 participants|
|Official Title:||Project to Understand & Research Preterm Pregnancy Outcomes-South Asia (PURPOSe)|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||October 1, 2020|
|Estimated Study Completion Date :||October 1, 2021|
- Cause of Death [ Time Frame: At time of study enrollment of mother ]Cause of death among preterm deaths and stillbirths.
- Neonatal Death [ Time Frame: At time of study enrollment of mother ]Evaluate the rate of mortality by gestational age and birth weight by taking weight post-mortem and estimating gestational age
- Preterm Death and Stillbirth Placental Pathology [ Time Frame: At time of study enrollment of mother ]Determine the placental pathology associated with stillbirth and preterm deaths by performing post-mortem autopsy
- Stillbirth and Preterm Death Pathogens [ Time Frame: Following stillbirth or infant death ]Determine the pathogens associated with stillbirth and preterm deaths by examination of samples collected from fetus/neonate at autopsy and maternal samples collected at time of delivery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438110
|J.J.M. Medical College Hospitals|
|Jinnah Postgrad Medical Center|
|National Institute of Child Health|
|Principal Investigator:||Elizabeth McClure, PhD||RTI International|