NCT03438110

Asia Pregnancy Outcomes Study

Completed Last updated 13 August 2025

What this trial tests

trial in Neonatal Death in 1,226 participants. Completed in 12 February 2020.

Timeline

1 September 2018

Primary endpoint
12 February 2020

12 February 2020

Quick facts

Lead sponsor	RTI International
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,226
Start date	1 September 2018
Primary completion	12 February 2020
Estimated completion	12 February 2020
Sites	3 locations across Pakistan, India

Conditions studied

• Neonatal Death — all drugs for Neonatal Death →
• Stillbirth — all drugs for Stillbirth →

Sponsor

RTI International — full company profile →

Who can join

Adults 14 to 45, female only, with Neonatal Death or Stillbirth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The project to understand and research preterm pregnancy outcomes and stillbirths in South Asia (PURPOSe): a protocol of a prospective, cohort study of causes of mortality among preterm births and stillbirths.
   McClure EM, Saleem S, Goudar SS, Dhaded S, et al · · 2018 · cited 27× · PMID 29945651 · DOI 10.1186/s12978-018-0528-1
2. Factors Associated With Parental Acceptance of Minimally Invasive Tissue Sampling to Identify the Causes of Stillbirth and Neonatal Death.
   Tikmani SS, Saleem S, Moore JL, Reza S, et al · · 2021 · cited 8× · PMID 34910175 · DOI 10.1093/cid/ciab829
3. Predictors of Preterm Neonatal Mortality in India and Pakistan: A Secondary Analysis of Data from PURPOSe Study.
   Tikmani SS, Saleem S, Sadia A, M Bann C, et al · · 2024 · cited 2× · PMID 38487208 · DOI 10.1177/2333794x241236617