Maternal Newborn Health Registry (MNH)

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

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.

Study Overview

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.

Study Type

Observational

Enrollment (Estimated)

950000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Elizabeth McClure, PHD
  • Phone Number: 919-316-3773
  • Email: mcclure@rti.org

Study Locations

      • Dhaka, Bangladesh, 1212
        • Recruiting
        • ICDDRB
        • Contact:
        • Principal Investigator:
          • Rashidul Haque, MD
      • Kinshasa, Congo, The Democratic Republic of the
        • Recruiting
        • Kinshasa School of Public Health
        • Contact:
          • Antoinette Tshefu, MD, MPH, PhD
          • Phone Number: +243 810 156 910
          • Email: antotshe@yahoo.com
        • Principal Investigator:
          • Antoinette Tshefu, MD, MPH, PhD
      • Guatemala City, Guatemala, 01011
        • Recruiting
        • Institute for Nutrition of Central America and Panama (INCAP)
        • Contact:
        • Principal Investigator:
          • Manolo Mazariegos, MD
      • Nagpur, India
        • Recruiting
        • Lata Medical Research Foundation
        • Contact:
        • Principal Investigator:
          • Archana Patel, MD, DNB, MSCE
    • Karnataka
      • Belgaum, Karnataka, India
        • Recruiting
        • KLE Academy of Higher Education and Research
        • Contact:
        • Principal Investigator:
          • Shivaprasad S. Goudar, MD, mhpe
      • Karachi, Pakistan, 74800
        • Recruiting
        • The Aga Khan University
        • Contact:
        • Principal Investigator:
          • Sarah Saleem, MD
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Waldemar A. Carlo, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Denver
        • Contact:
        • Sub-Investigator:
          • Nancy Krebs, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5119
        • Recruiting
        • Indiana University School of Medicine
        • Contact:
        • Principal Investigator:
          • Ed Liechty, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston University
        • Contact:
          • Patricia L. Hibberd, MD, PhD
          • Phone Number: 617-636-2431
          • Email: plh0@bu.edu
        • Principal Investigator:
          • Patricia L. Hibberd, MD, PhD
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
        • Contact:
        • Principal Investigator:
          • Robert Goldenberg, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27510
        • Recruiting
        • University of North Carolina
        • Contact:
        • Principal Investigator:
          • Carl Bose, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Contact:
        • Principal Investigator:
          • Richard J. Derman, MD, MPH
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virgina
        • Contact:
        • Principal Investigator:
          • William A. Petri, MD
      • Lusaka, Zambia
        • Recruiting
        • University Teaching Hospital
        • Contact:
          • Elwyn Chomba, MBChB,DCH,MRCP
          • Phone Number: +260 211 252 094
          • Email: echomba@zamnet.zm
        • Principal Investigator:
          • Elwyn Chomba, MBChB,DCH,MRCP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All pregnant women meeting participant-level criteria and the infant(s) from their pregnancy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women
Pregnant women in the MNH cluster

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.

Male and Female Infants
Male and Female Infants delivered in the clusters

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal mortality rate
Time Frame: 42 days post delivery
Maternal mortality rate by site and cluster
42 days post delivery
Stillbirth rate
Time Frame: Delivery
Stillbirth rate by site and cluster
Delivery
Early neonatal mortality rate
Time Frame: 28 days post delivery
ENM by site and by cluster
28 days post delivery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Marion Koso-Thomas, MD, Center for Research for Mothers and Children (NICHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2008

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

February 21, 2010

First Submitted That Met QC Criteria

February 21, 2010

First Posted (Estimated)

February 23, 2010

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on 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.

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