Maternal Newborn Health Registry

Conditions

• Pregnancy Outcome Trends in Low-resource Geographic Areas

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Accepted

Interventions

• 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. — OTHER
  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.

Study Details

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.

Key Dates

Start date

May 31, 2008

Status verified

Jan 2026

Primary completion

Jan 31, 2030

Completion

May 31, 2030

Study Design

Enrollment

950,000 participants (estimated)

Arms

• Arm: Pregnant women
  Pregnant women in the MNH cluster
• Arm: Male and Female Infants
  Male and Female Infants delivered in the clusters

Primary Outcome Measure

Maternal mortality rate [ Time Frame: 42 days post delivery ]

Central Contacts

• Marion Koso-Thomas, MD
  301-435-6873
  [email protected]
• Elizabeth McClure, PHD
  919-316-3773
  [email protected]

Locations (8)

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