Global Network for Women's and Children's Health Research Data Coordinating Center
- Funded by National Institutes of Health (NIH)
- Total publications:0 publications
Grant number: 3U24HD092094-04S1
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Key facts
Disease
COVID-19Start & end year
2021.02022.0Known Financial Commitments (USD)
$241,469Funder
National Institutes of Health (NIH)Principal Investigator
. Elizabeth McClureResearch Location
United States of America, Congo (DRC)…Lead Research Institution
RESEARCH TRIANGLE INSTITUTEResearch Priority Alignment
N/A
Research Category
Pathogen: natural history, transmission and diagnostics
Research Subcategory
Immunity
Special Interest Tags
N/A
Study Type
Non-Clinical
Clinical Trial Details
N/A
Broad Policy Alignment
Pending
Age Group
Adults (18 and older)
Vulnerable Population
WomenPregnant women
Occupations of Interest
Unspecified
Abstract
The aim of the "COVID-19 prevalence during pregnancy and pregnancy outcomes in 8 LMIC: A Global Network for Women's and Children's Health" study is to determine the prevalence of COVID-19 antibodies in pregnant /recently delivered women in 8 Global Network sites (in DRC, Kenya, Zambia, Bangladesh, India [2 sites], Pakistan and Guatemala) and its association with pregnancy outcomes. RTI International serves as the study data coordinating center. Specifically, the study will determine the prevalence of COVID-19 antibodies in pregnant/recently delivered women in 8 Global Network sites using antibody testing; compare the maternal, fetal and neonatal outcomes of COVID-19 antibody positive women vs. antibody negative women (low birth weight, preterm birth, fetal growth restriction, stillbirth and neonatal mortality); and will assess knowledge, attitudes and practices of pregnant women related to COVID-19 during pregnancy. This will be a prospective, population-based, cohort study conducted of 20,000 women which will be conducted within the Global Network's Maternal and Newborn Health Registry (MNHR), a population-based observational study, over a 12-month study period. Following enrollment in the MNHR, women will be requested to consent for the COVID- 19 study which may include a blood sample collected at first antenatal care visit (4 sites) and/or at delivery (all sites). All women enrolled will also have pregnancy outcomes collected at delivery and 6-weeks postpartum. Maternal samples will be assessed for COVID-19 antibodies, using the same testing analyses methodology across all study sites, coordinated and supported through RTI International. Analyses will be conducted to assess the prevalence of COVID-19 antibodies in the population, and to assess the association of antibodies with maternal and newborn outcomes.