Tracking pregnancy outcomes in low-resource areas

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

This study looks at pregnancy outcomes like stillbirths and maternal deaths in low-resource areas to see how COVID-19 affects them and to help improve health care for mothers and babies.

Quick facts

• Study type: Observational
• Enrollment: 950000 (estimated)
• Sex: All
• Sponsor: NICHD Global Network for Women's and Children's Health (Research network)
• Locations: 15 sites (Birmingham, Alabama and 14 other locations)
• Trial ID: NCT01073475 on ClinicalTrials.gov

What this trial studies

This observational study aims to quantify and analyze trends in pregnancy outcomes, such as stillbirths and maternal mortality, in low-resource geographic areas. By establishing a vital registry system, the study seeks to gather essential data on maternal and neonatal health, which is often lacking due to weak healthcare systems. Additionally, a sub-study will investigate the prevalence of COVID-19 among pregnant women and its impact on pregnancy outcomes. The findings will inform public health policies and interventions to improve maternal and child health in these communities.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women intending to deliver within the designated study clusters.

Not a fit: Patients who opt out of consent to include their data in the study will not benefit from this research.

Why it matters

Potential benefit: If successful, this study could lead to improved maternal and neonatal health outcomes in low-resource settings.

How similar studies have performed: Other studies have shown success in similar approaches, particularly in improving maternal and neonatal health outcomes through data collection and targeted interventions.

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

Where this trial is running

Birmingham, Alabama and 14 other locations

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

Study contacts

• Study coordinator: Marion Koso-Thomas, MD

Conditions Pregnancy Outcome Trends in Low-resource Geographic Areas; Pregnancy; Maternal mortality; Neonatal mortality; Stillbirth; Maternal Cause of Death; Neonatal Cause of Death