Maternal Newborn Health Registry
- Conditions
- Pregnancy Outcome Trends in Low-resource Geographic Areas
- Interventions
- 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.
- Registration Number
- NCT01073475
- Lead Sponsor
- NICHD Global Network for Women's and Children's Health
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 950000
-
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
-
Participant-level
- Opt out of consent to include data in the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pregnant women 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. Pregnant women in the MNH cluster Male and Female Infants 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. Male and Female Infants delivered in the clusters
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Peri-partum and postpartum depression At delivery and 6 weeks post-partum Data collected by site and by cluster
Prevalence of COVID-19 antibody positive results during pregnancy At 12-14 week antenatal care visit, at delivery or 14 days after Data collected by site and by cluster
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 At delivery, 7 days post delivery and 28 days post delivery Data collected by site and by cluster
Cause of maternal death at less than or equal to 42 days 42 days post delivery Data collected by site and by cluster
Cause of neonatal death at less than or equal to 28 days 28 days post delivery Data collected by site and by cluster
Maternal outcomes (rate of infection, timing of infection, types of symptoms, death, cause of death) associated with COVID-19 positivity At delivery, 42 days post delivery Data collected by site and by cluster
Knowledge, attitudes, and practices of pregnant women related to COVID-19 infection during pregnancy At the 12-14 week Antenatal Care visit Data collected by site and by cluster
Trial Locations
- Locations (15)
The Aga Khan University
🇵🇰Karachi, Pakistan
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Boston University
🇺🇸Boston, Massachusetts, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Columbia University
🇺🇸New York, New York, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
University of Virgina
🇺🇸Charlottesville, Virginia, United States
ICDDRB
🇧🇩Dhaka, Bangladesh
Kinshasa School of Public Health
🇨🇩Kinshasa, Congo, The Democratic Republic of the
KLE Academy of Higher Education and Research
🇮🇳Belgaum, Karnataka, India
Institute for Nutrition of Central America and Panama (INCAP)
🇬🇹Guatemala City, Guatemala
Lata Medical Research Foundation
🇮🇳Nagpur, India
University Teaching Hospital
🇿🇲Lusaka, Zambia
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States