Maternal Newborn Health Registry

NCT01073475 · tracked via the Priya Life Science India tracker

Sponsor

NICHD Global Network for Women's and Children's Health

Phase

Observational

Started

2008-05

Last updated

2026-01-21

Condition(s) studied

Pregnancy Outcome Trends in Low-resource Geographic Areas

Investigational drug(s) / intervention(s)

There is no intervention associated with the parent MNHR study. For the MNHR COVID sub-study, participants will be asked to provide a blood specimen at or near delivery.

There is no intervention associated with the parent MNHR study. For the MNHR COVID sub-study, participants will be asked to provide a blood specimen at or near delivery.: There is no intervention associated with the parent MNHR study For the MNHR COVID sub-study, each woman will be asked to provide a blood specimen of approximately 3-5 cc at or near delivery (at delivery or 14 days after) to be tested for COVID-19 antibodies. The person collecting the specimen will be a trained member of the registry staff. The ZEUS ELISA SARS-CoV-2 IgG Test System will be used and run at each site. RTI International will provide central quality support of the analyses.

Study summary

The primary purpose of this population-based study is to quantify and understand the trends in pregnancy outcomes in defined low-resource geographic areas over time, in order to provide population-based data on stillbirths, neonatal and maternal mortality.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: * Community-level * Appropriate for long-term registry data collection and the conduct of ongoing Global Network research * At least 300 deliveries per year * Participant-level * Pregnant women intending to deliver within study cluster * Women who deliver within the study cluster * Women who reside in the community but are transferred for care at delivery Exclusion Criteria: * Participant-level * Opt out of consent to include data in the study

Primary outcome measure(s)

Maternal mortality rate — 42 days post delivery
Maternal mortality rate by site and cluster
Stillbirth rate — Delivery
Stillbirth rate by site and cluster
Early neonatal mortality rate — 28 days post delivery
ENM by site and by cluster

Trial sites (15)

Facility	City	Region	Status
University of Alabama at Birmingham	Birmingham	Alabama	Recruiting
University of Colorado Denver	Aurora	Colorado	Recruiting
Indiana University School of Medicine	Indianapolis	Indiana	Recruiting
Boston University	Boston	Massachusetts	Recruiting
Columbia University	New York	New York	Recruiting
University of North Carolina	Chapel Hill	North Carolina	Recruiting
Thomas Jefferson University	Philadelphia	Pennsylvania	Recruiting
University of Virgina	Charlottesville	Virginia	Recruiting
ICDDRB	Dhaka	Bangladesh	Recruiting
Kinshasa School of Public Health	Kinshasa	Democratic Republic of the Congo	Recruiting
Institute for Nutrition of Central America and Panama (INCAP)	Guatemala City	Departamento de Guatemala	Recruiting
Lata Medical Research Foundation	Nagpur	India	Recruiting
KLE Academy of Higher Education and Research	Belagavi	Karnataka	Recruiting
The Aga Khan University	Karachi	Pakistan	Recruiting
University Teaching Hospital	Lusaka	Zambia	Recruiting

More NICHD Global Network for Women's and Children's Health trials in India

Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries Recruiting

Caffeine for Hypoxic Ischemic Encephalopathy Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01073475 on ClinicalTrials.gov ↗ ← All trials in India