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Maternal Newborn Health Registry (MNH)

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ClinicalTrials.gov Identifier: NCT01073475
Recruitment Status : Unknown
Verified March 2018 by NICHD Global Network for Women's and Children's Health.
Recruitment status was:  Recruiting
First Posted : February 23, 2010
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health

Tracking Information
First Submitted Date February 21, 2010
First Posted Date February 23, 2010
Last Update Posted Date March 4, 2019
Study Start Date May 2008
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 2, 2018)
  • Maternal mortality rate [ Time Frame: 42 days post delivery ]
    Maternal mortality rate by site and cluster
  • Stillbirth rate [ Time Frame: Delivery ]
    Stillbirth rate by site and cluster
  • Early neonatal mortality rate [ Time Frame: 28 days post delivery ]
    ENM by site and by cluster
Original Primary Outcome Measures
 (submitted: February 21, 2010)
  • Maternal mortality rate [ Time Frame: 42 days post delivery ]
  • Stillbirth rate [ Time Frame: Delivery ]
  • Early neonatal mortality rate [ Time Frame: 28 days post delivery ]
Change History
Current Secondary Outcome Measures
 (submitted: April 2, 2018)
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: February 21, 2010)
  • Cause of maternal death at less than or equal to 42 days [ Time Frame: 42 days post delivery ]
  • Cause of neonatal death at less than or equal to 28 days [ Time Frame: 28 days post delivery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Maternal Newborn Health Registry
Official Title Global Network for Women's and Children's Health Research Maternal Newborn Health Registry
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All pregnant women meeting participant-level criteria and the infant(s) from their pregnancy.
Condition Pregnancy Outcome Trends in Low-resource Geographic Areas
Intervention Other: There is no intervention associated with this study.
There is no intervention associated with this study
Study Groups/Cohorts
  • Pregnant women
    Pregnant women in the MNH cluster
    Intervention: Other: There is no intervention associated with this study.
  • Male and Female Infants
    Male and Female Infants delivered in the clusters
    Intervention: Other: There is no intervention associated with this study.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 28, 2019)		 750000
Original Estimated Enrollment
 (submitted: February 21, 2010)		 60000
Estimated Study Completion Date May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Bangladesh,   Congo, The Democratic Republic of the,   Guatemala,   India,   Kenya,   Pakistan,   United States,   Zambia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01073475
Other Study ID Numbers CP MNH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party NICHD Global Network for Women's and Children's Health
Study Sponsor NICHD Global Network for Women's and Children's Health
Collaborators Not Provided
Investigators
Study Director: Marion Koso-Thomas, MD Center for Research for Mothers and Children (NICHD)
PRS Account NICHD Global Network for Women's and Children's Health
Verification Date March 2018