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.
The purpose of the Global Network for Women's and Children's Health Research is to develop and test feasible, sustainable interventions to improve the outcome of women and children and to develop research capacity in resource-poor settings. Because most of the sites have weak health care systems, unacceptably high rates of maternal and neonatal mortality and lack birth and death registries, they lack precise data on outcomes and measures of care. Information from a vital registry system will allow the Global Network to document maternal and neonatal mortality, design trials to address the major causes of poor outcome, assess the outcome of our interventions, and ultimately disseminate the results as the basis of public health policy. A sub-study to the Maternal Newborn Health Registry will be conducted to understand the prevalence of COVID-19 among pregnant women, the association between COVID-19 and pregnancy outcomes, and the Knowledge, Attitudes, and Practices of pregnant women related to COVID-19 and its prevention during pregnancy. Women who consent to participation in the MNHR COVID sub-study will provide a blood specimen at or near delivery to be tested for COVID-19 antibodies. Four Global Network sites (Guatemala, Bangladesh, Nagpur India and Pakistan) will also collect and analyze blood specimen from participants during antenatal care visits.
Study Type
OBSERVATIONAL
Enrollment
950,000
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.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGUniversity of Colorado Denver
Aurora, Colorado, United States
Maternal mortality rate
Maternal mortality rate by site and cluster
Time frame: 42 days post delivery
Stillbirth rate
Stillbirth rate by site and cluster
Time frame: Delivery
Early neonatal mortality rate
ENM by site and by cluster
Time frame: 28 days post delivery
Cause of maternal death at less than or equal to 42 days
Data collected by site and by cluster
Time frame: 42 days post delivery
Cause of neonatal death at less than or equal to 28 days
Data collected by site and by cluster
Time frame: 28 days post delivery
Prevalence of COVID-19 antibody positive results during pregnancy
Data collected by site and by cluster
Time frame: At 12-14 week antenatal care visit, at delivery or 14 days after
Fetal/neonatal outcomes (spontaneous abortion, stillbirth, birth weight (g), and fetal growth restriction, early (7-day) and late (28-day) neonatal death, cause of death, congenital infections, and malformations) associated with COVID-19 positivity
Data collected by site and by cluster
Time frame: At delivery, 7 days post delivery and 28 days post delivery
Maternal outcomes (rate of infection, timing of infection, types of symptoms, death, cause of death) associated with COVID-19 positivity
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Indiana University School of Medicine
Indianapolis, Indiana, United States
RECRUITINGBoston University
Boston, Massachusetts, United States
RECRUITINGColumbia University
New York, New York, United States
RECRUITINGUniversity of North Carolina
Chapel Hill, North Carolina, United States
RECRUITINGThomas Jefferson University
Philadelphia, Pennsylvania, United States
RECRUITINGUniversity of Virgina
Charlottesville, Virginia, United States
RECRUITINGICDDRB
Dhaka, Bangladesh
RECRUITINGKinshasa School of Public Health
Kinshasa, Democratic Republic of the Congo
RECRUITING...and 5 more locations
Data collected by site and by cluster
Time frame: At delivery, 42 days post delivery
Knowledge, attitudes, and practices of pregnant women related to COVID-19 infection during pregnancy
Data collected by site and by cluster
Time frame: At the 12-14 week Antenatal Care visit
Peri-partum and postpartum depression
Data collected by site and by cluster
Time frame: At delivery and 6 weeks post-partum