Trial record 14 of 15 for:
infant care | Open Studies | nichd [Lead] | NIH
Maternal Newborn Health Registry (MNH)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01073475
First received: February 21, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
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: | April 2011 |
| Estimated Primary Completion Date: | March 2011 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073475
Contacts
| Contact: Linda Wright, MD | 301-402-0830 | wrightl@exchange.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
Investigators
| Study Director: | Linda Wright, MD | Center for Research for Mothers and Children (NICHD) |
More Information
Additional Information:
No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Elizabeth McClure, RTI International |
| ClinicalTrials.gov Identifier: | NCT01073475 History of Changes |
| Other Study ID Numbers: | CP MNH |
| Study First Received: | February 21, 2010 |
| Last Updated: | February 21, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
Pregnancy Maternal mortality Neonatal mortality Stillbirth |
ClinicalTrials.gov processed this record on May 16, 2013