Maternal Newborn Health Registry

Pregnancy Outcome Trends in Low-resource Geographic Areas Clinical Trial

— MNH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01073475
• Other study ID #: CP MNH
• Status: Recruiting
• Start date: May 2008
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: NICHD Global Network for Women's and Children's Health
• Contact: Marion Koso-Thomas, MD
• Phone: 301-435-6873
• Email: marion.koso-thomas[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 950000
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Outcome Trends in Low-resource Geographic Areas

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
NICHD Global Network for Women's and Children's Health

Countries where clinical trial is conducted

United States,  Zambia,  Bangladesh,  Congo, The Democratic Republic of the,  Guatemala,  India,  Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal mortality rate	Maternal mortality rate by site and cluster	42 days post delivery
Primary	Stillbirth rate	Stillbirth rate by site and cluster	Delivery
Primary	Early neonatal mortality rate	ENM by site and by cluster	28 days post delivery
Secondary	Cause of maternal death at less than or equal to 42 days	Data collected by site and by cluster	42 days post delivery
Secondary	Cause of neonatal death at less than or equal to 28 days	Data collected by site and by cluster	28 days post delivery
Secondary	Prevalence of COVID-19 antibody positive results during pregnancy	Data collected by site and by cluster	At 12-14 week antenatal care visit, at delivery or 14 days after
Secondary	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	At delivery, 7 days post delivery and 28 days post delivery
Secondary	Maternal outcomes (rate of infection, timing of infection, types of symptoms, death, cause of death) associated with COVID-19 positivity	Data collected by site and by cluster	At delivery, 42 days post delivery
Secondary	Knowledge, attitudes, and practices of pregnant women related to COVID-19 infection during pregnancy	Data collected by site and by cluster	At the 12-14 week Antenatal Care visit
Secondary	Peri-partum and postpartum depression	Data collected by site and by cluster	At delivery and 6 weeks post-partum

External Links

•   The Global Network for Women's and Children's Health Research website contains information for the MNH Registry as well as other Global Network studies