Maternal Newborn Health Registry (MNH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by NICHD Global Network for Women's and Children's Health
Sponsor:
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier:
NCT01073475
First received: February 21, 2010
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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 Intervention
Pregnancy Outcome Trends in Low-resource Geographic Areas
Other: There is no intervention associated with this study.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Global Network for Women's and Children's Health Research Maternal Newborn Health Registry

Resource links provided by NLM:


Further study details as provided by NICHD Global Network for Women's and Children's Health:

Primary Outcome Measures:
  • Maternal mortality rate [ Time Frame: 42 days post delivery ] [ Designated as safety issue: No ]
  • Stillbirth rate [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Early neonatal mortality rate [ Time Frame: 28 days post delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cause of maternal death at less than or equal to 42 days [ Time Frame: 42 days post delivery ] [ Designated as safety issue: No ]
  • Cause of neonatal death at less than or equal to 28 days [ Time Frame: 28 days post delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 60000
Study Start Date: May 2008
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pregnant women Other: There is no intervention associated with this study.
There is no intervention associated with this study
Male and Female Infants Other: There is no intervention associated with this study.
There is no intervention associated with this study

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073475

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

Locations
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: Michael Hambidge, MD    303-724-3206      
Principal Investigator: Michael Hambidge, MD         
Sub-Investigator: Nancy Krebs, MD         
United States, Delaware
Christiana Care Recruiting
Newark, Delaware, United States, 19718
Contact: Richard J. Derman, MD, MPH    302-733-3350    rderman@christianacare.org   
Principal Investigator: Richard J. Derman, MD, MPH         
United States, Indiana
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202-5119
Contact: Ed Liechty, MD    317-274-4715    eliecht@iupui.edu   
Principal Investigator: Ed Liechty, MD         
United States, Massachusetts
Tufts University School of Medicine Recruiting
Boston, Massachusetts, United States, 02111
Contact: Patricia L. Hibberd, MD, PhD    617-636-2431    patricia.hibberd@tufts.edu   
Principal Investigator: Patricia L. Hibberd, MD, PhD         
United States, Pennsylvania
Drexel University College of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Robert Goldenberg, MD    215-762-2014    rgoldenb@drexelmed.edu   
Principal Investigator: Robert Goldenberg, MD         
Guatemala
Institute for Nutrition of Central America and Panama (INCAP & FANCAP) Recruiting
Guatemala City, Guatemala, 01011
Contact: Manolo Mazariegos, MD       mmazarie@turbonett.com   
Principal Investigator: Manolo Mazariegos, MD         
Sub-Investigator: Ana Lucia Garces, MD, MPH         
India
Jawaharlal Nehru Medical College Recruiting
Belgaum, Karnataka, India
Contact: Bhalchandra S. Kodkany, MD, MBBS       drkodkany@jnmc.edu   
Principal Investigator: Bhalchandra S. Kodkany, MD, MBBS         
Indira Gandhi Government Medical College Recruiting
Nagpur, India
Contact: Archana Patel, MD, DNB, MSCE       dr_apatell@yahoo.com   
Principal Investigator: Archana Patel, MD, DNB, MSCE         
Kenya
Moi University School of Medicine Recruiting
Eldoret, Kenya
Contact: Fabian Esamai, MBChB, MMed, PhD       fesami@africaonline.co.ke   
Principal Investigator: Fabian Esamai, MBChB, MMed, PhD         
Pakistan
The Aga Khan University Recruiting
Karachi, Pakistan, 74800
Contact: Omrana Pasha, MD       omranapasha@yahoo.com   
Principal Investigator: Omrana Pasha, MD         
Zambia
University Teaching Hospital Recruiting
Lusaka, Zambia
Contact: Elwyn Chomba, MBChB, DCH, MRCP       echomba@zamnet.zm   
Principal Investigator: Elwyn Chomba, MBChB, DCH, MRCP         
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Investigators
Study Director: Marion Koso-Thomas, MD Center for Research for Mothers and Children (NICHD)
  More Information

Additional Information:
No publications provided by NICHD Global Network for Women's and Children's Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT01073475     History of Changes
Other Study ID Numbers: CP MNH
Study First Received: February 21, 2010
Last Updated: July 29, 2014
Health Authority: United States: Federal Government

Keywords provided by NICHD Global Network for Women's and Children's Health:
Pregnancy
Maternal mortality
Neonatal mortality
Stillbirth

ClinicalTrials.gov processed this record on August 21, 2014