Recruiting

Observational Study

Sponsor:

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

Code:

NCT01073475

Conditions

Pregnancy Outcome Trends in Low-resource Geographic Areas

Eligibility Criteria

Sex: All

Age: 0+

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.

Study Details

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.

Conditions

Pregnancy Outcome Trends in Low-resource Geographic Areas

Study ID

NCT01073475

Start date

May, 2008

Status verified date

Jan, 2026

Completion date

May, 2030

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

950000 participants

Anticipated

Interventions and Outcome Measures

Arms

Pregnant women

Pregnant women in the MNH cluster

Male and Female Infants

Male and Female Infants delivered in the clusters

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.

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.

Primary outcome measure

  • Maternal mortality rate [ Time Frame: 42 days post delivery ]
  • Stillbirth rate [ Time Frame: Delivery ]
  • Early neonatal mortality rate [ Time Frame: 28 days post delivery ]

Central Contacts and Locations

Central contacts

Marion Koso-Thomas, MD

301-435-6873marion.koso-thomas@nih.gov

Elizabeth McClure, PHD

919-316-3773mcclure@rti.org

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Waldemar A. Carlo, MD

205-934-4680Wcarlo@PEDS.UAB.EDU

Principal Investigator:

Waldemar A. Carlo, MD

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Nancy Krebs, MD

Nancy.krebs@cuanschutz.edu

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202-5119

Contacts

Ed Liechty, MD

317-274-4715eliecht@iu.edu

Principal Investigator:

Ed Liechty, MD

Boston University

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Patricia L. Hibberd, MD, PhD

617-636-2431plh0@bu.edu

Principal Investigator:

Patricia L. Hibberd, MD, PhD

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Robert Goldenberg, MD

215-762-2014rlg88@cumc.columbia.edu

Principal Investigator:

Robert Goldenberg, MD

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27510

Contacts

Carl Bose, MD

984-974-7849carl_bose@med.unc.edu

Principal Investigator:

Carl Bose, MD

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Richard J. Derman, MD, MPH

302-733-3350Richard.Derman@jefferson.edu

Principal Investigator:

Richard J. Derman, MD, MPH

University of Virgina

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Principal Investigator

434-924-5621wap3g@virginia.edu

Principal Investigator:

William A. Petri, MD

More Information

Sponsor

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

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Keywords

  • Pregnancy
  • Maternal mortality
  • Neonatal mortality
  • Stillbirth
  • Maternal Cause of Death
  • Neonatal Cause of Death

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NICHD Global Network for Women's and Children's Health on 2026-01-21.