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Maternal Newborn Health Registry (MNH)

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ClinicalTrials.gov Identifier: NCT01073475
Recruitment Status : Recruiting
First Posted : February 23, 2010
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health

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.

Condition or disease Intervention/treatment
Pregnancy Outcome Trends in Low-resource Geographic Areas Other: 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.

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.

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Study Type : Observational
Estimated Enrollment : 950000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Global Network for Women's and Children's Health Research Maternal Newborn Health Registry
Study Start Date : May 2008
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stillbirth

Group/Cohort Intervention/treatment
Pregnant women
Pregnant women in the MNH cluster
Other: 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.


Male and Female Infants
Male and Female Infants delivered in the clusters
Other: 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 Measures :
  1. Maternal mortality rate [ Time Frame: 42 days post delivery ]
    Maternal mortality rate by site and cluster

  2. Stillbirth rate [ Time Frame: Delivery ]
    Stillbirth rate by site and cluster

  3. Early neonatal mortality rate [ Time Frame: 28 days post delivery ]
    ENM by site and by cluster


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073475


Contacts
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Contact: Marion Koso-Thomas, MD 301-435-6873 marion.koso-thomas@nih.gov
Contact: Elizabeth McClure, PHD 919-316-3773 mcclure@rti.org

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Waldemar A. Carlo, MD    205-934-4680    Wcarlo@PEDS.UAB.EDU   
Principal Investigator: Waldemar A. Carlo, MD         
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Nancy Krebs, MD       Nancy.krebs@cuanschutz.edu   
Sub-Investigator: Nancy Krebs, MD         
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202-5119
Contact: Ed Liechty, MD    317-274-4715    eliecht@iu.edu   
Principal Investigator: Ed Liechty, MD         
United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02115
Contact: Patricia L. Hibberd, MD, PhD    617-636-2431    plh0@bu.edu   
Principal Investigator: Patricia L. Hibberd, MD, PhD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Robert Goldenberg, MD    215-762-2014    rlg88@cumc.columbia.edu   
Principal Investigator: Robert Goldenberg, MD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27510
Contact: Carl Bose, MD    984-974-7849    carl_bose@med.unc.edu   
Principal Investigator: Carl Bose, MD         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Richard J. Derman, MD, MPH    302-733-3350    Richard.Derman@jefferson.edu   
Principal Investigator: Richard J. Derman, MD, MPH         
United States, Virginia
University of Virgina Not yet recruiting
Charlottesville, Virginia, United States, 22908
Contact: Principal Investigator    434-924-5621    wap3g@virginia.edu   
Principal Investigator: William A. Petri, MD         
Bangladesh
ICDDRB Not yet recruiting
Dhaka, Bangladesh, 1212
Contact: Site Principal Investigator       rhaque@icddrb.org   
Principal Investigator: Rashidul Haque, MD         
Congo, The Democratic Republic of the
Kinshasa School of Public Health Recruiting
Kinshasa, Congo, The Democratic Republic of the
Contact: Antoinette Tshefu, MD, MPH, PhD    +243 810 156 910    antotshe@yahoo.com   
Principal Investigator: Antoinette Tshefu, MD, MPH, PhD         
Guatemala
Institute for Nutrition of Central America and Panama (INCAP) Recruiting
Guatemala City, Guatemala, 01011
Contact: Manolo Mazariegos, MD       mmazariegos@incap.int   
Principal Investigator: Manolo Mazariegos, MD         
India
KLE Academy of Higher Education and Research Recruiting
Belgaum, Karnataka, India
Contact: Shivaprasad S. Goudar, MD, MHPE       sgoudar@jnmc.edu   
Principal Investigator: Shivaprasad S. Goudar, MD, mhpe         
Lata Medical Research Foundation Recruiting
Nagpur, India
Contact: Archana Patel, MD, DNB, MSCE    91-98 2315 4463    dr_apatel@yahoo.com   
Principal Investigator: Archana Patel, MD, DNB, MSCE         
Kenya
Moi University School of Medicine Recruiting
Eldoret, Kenya
Contact: Fabian Esamai, MMed, PhD    +254 733 836 410    fesamai2007@gmail.com   
Principal Investigator: Fabian Esamai, MMed, PhD         
Pakistan
The Aga Khan University Recruiting
Karachi, Pakistan, 74800
Contact: Sarah Saleem, MD    92-213-486-4819    Sarah.saleem@aku.edu   
Principal Investigator: Sarah Saleem, MD         
Zambia
University Teaching Hospital Recruiting
Lusaka, Zambia
Contact: Elwyn Chomba, MBChB,DCH,MRCP    +260 211 252 094    echomba@zamnet.zm   
Principal Investigator: Elwyn Chomba, MBChB,DCH,MRCP         
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Investigators
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Study Director: Marion Koso-Thomas, MD Center for Research for Mothers and Children (NICHD)
  Study Documents (Full-Text)

Documents provided by NICHD Global Network for Women's and Children's Health:
Study Protocol  [PDF] August 30, 2021
Informed Consent Form  [PDF] November 3, 2016

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT01073475    
Other Study ID Numbers: CP MNH
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: November 2021
Keywords provided by NICHD Global Network for Women's and Children's Health:
Pregnancy
Maternal mortality
Neonatal mortality
Stillbirth
Maternal Cause of Death
Neonatal Cause of Death