NCT01073475

Maternal Newborn Health Registry

Global Network for Women's and Children's Health Research Maternal Newborn Health Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 950,000 (estimated)
• Sponsor: NICHD Global Network for Women's and Children's Health · Network
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Pregnancy Outcome Trends in Low-resource Geographic Areas

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2008-05-01
• Primary completion: 2030-01-01
• Completion: 2030-05-01
• First posted: 2010-02-23
• Last updated: 2026-01-21

Locations

15 sites across 7 countries: United States, Bangladesh, Democratic Republic of the Congo, Guatemala, India, Pakistan, Zambia