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ClinicalTrials.gov ID

NCT01073475

Lead Sponsor

NICHD Global Network for Women's and Children's HealthNETWORK

Overall Status

Recruiting

Study Type

Observational

Enrollment

950,000Estimated

Last Update Posted

Jan 21, 2026Actual

Start Date

May 2008Actual

Primary Completion Date

Jan 2030Estimated

Completion Date

May 2030Estimated

Official Title

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

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.

• Pregnancy Outcome Trends in Low-resource Geographic Areas

• 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.

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

NICHD Global Network for Women's and Children's HealthNETWORK

rhaque@icddrb.org