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Maternal Newborn Health Registry (MNH)

This study is currently recruiting participants.
Verified November 2016 by NICHD Global Network for Women's and Children's Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT01073475
First Posted: February 23, 2010
Last Update Posted: December 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health
  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

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 ]
  • Stillbirth rate [ Time Frame: Delivery ]
  • Early neonatal mortality rate [ Time Frame: 28 days post delivery ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600000
Study Start Date: May 2008
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pregnant women
Pregnant women in the MNH cluster
Other: There is no intervention associated with this study.
There is no intervention associated with this study
Male and Female Infants
Male and Female Infants delivered in the clusters
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

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.


Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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
Contact: Marion Koso-Thomas, MD 301-435-6873 marion.koso-thomas@nih.gov
Contact: Elizabeth McClure, PHD 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    Michael.Hambidge@ucdenver.edu   
Principal Investigator: Michael Hambidge, MD         
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         
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: Ana Garces, MD, MPH    (502) 2471-3299    agarces@incap.int   
Principal 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         
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, MBChB, MMed, PhD    +254 733 836 410    fesamai2007@gmail.com   
Principal Investigator: Fabian Esamai, MBChB, 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
Study Director: Marion Koso-Thomas, MD Center for Research for Mothers and Children (NICHD)
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Wang ME, Patel AB, Hansen NI, Arlington L, Prakash A, Hibberd PL. Risk factors for possible serious bacterial infection in a rural cohort of young infants in central India. BMC Public Health. 2016 Oct 19;16(1):1097.
Hibberd PL, Hansen NI, Wang ME, Goudar SS, Pasha O, Esamai F, Chomba E, Garces A, Althabe F, Derman RJ, Goldenberg RL, Liechty EA, Carlo WA, Hambidge KM, Krebs NF, Buekens P, McClure EM, Koso-Thomas M, Patel AB. Trends in the incidence of possible severe bacterial infection and case fatality rates in rural communities in Sub-Saharan Africa, South Asia and Latin America, 2010-2013: a multicenter prospective cohort study. Reprod Health. 2016 May 24;13(1):65. doi: 10.1186/s12978-016-0177-1.
Bucher S, Marete I, Tenge C, Liechty EA, Esamai F, Patel A, Goudar SS, Kodkany B, Garces A, Chomba E, Althabe F, Barreuta M, Pasha O, Hibberd P, Derman RJ, Otieno K, Hambidge K, Krebs NF, Carlo WA, Chemweno C, Goldenberg RL, McClure EM, Moore JL, Wallace DD, Saleem S, Koso-Thomas M. A prospective observational description of frequency and timing of antenatal care attendance and coverage of selected interventions from sites in Argentina, Guatemala, India, Kenya, Pakistan and Zambia. Reprod Health. 2015;12 Suppl 2:S12. doi: 10.1186/1742-4755-12-S2-S12. Epub 2015 Jun 8.
Althabe F, Moore JL, Gibbons L, Berrueta M, Goudar SS, Chomba E, Derman RJ, Patel A, Saleem S, Pasha O, Esamai F, Garces A, Liechty EA, Hambidge K, Krebs NF, Hibberd PL, Goldenberg RL, Koso-Thomas M, Carlo WA, Cafferata ML, Buekens P, McClure EM. Adverse maternal and perinatal outcomes in adolescent pregnancies: The Global Network's Maternal Newborn Health Registry study. Reprod Health. 2015;12 Suppl 2:S8. doi: 10.1186/1742-4755-12-S2-S8. Epub 2015 Jun 8.
Pasha O, Goudar SS, Patel A, Garces A, Esamai F, Chomba E, Moore JL, Kodkany BS, Saleem S, Derman RJ, Liechty EA, Hibberd PL, Hambidge K, Krebs NF, Carlo WA, McClure EM, Koso-Thomas M, Goldenberg RL. Postpartum contraceptive use and unmet need for family planning in five low-income countries. Reprod Health. 2015;12 Suppl 2:S11. doi: 10.1186/1742-4755-12-S2-S11. Epub 2015 Jun 8.
McClure EM, Saleem S, Goudar SS, Moore JL, Garces A, Esamai F, Patel A, Chomba E, Althabe F, Pasha O, Kodkany BS, Bose CL, Berreuta M, Liechty EA, Hambidge K, Krebs NF, Derman RJ, Hibberd PL, Buekens P, Manasyan A, Carlo WA, Wallace DD, Koso-Thomas M, Goldenberg RL. Stillbirth rates in low-middle income countries 2010 - 2013: a population-based, multi-country study from the Global Network. Reprod Health. 2015;12 Suppl 2:S7. doi: 10.1186/1742-4755-12-S2-S7. Epub 2015 Jun 8.
Patel A, Bucher S, Pusdekar Y, Esamai F, Krebs NF, Goudar SS, Chomba E, Garces A, Pasha O, Saleem S, Kodkany BS, Liechty EA, Kodkany B, Derman RJ, Carlo WA, Hambidge K, Goldenberg RL, Althabe F, Berrueta M, Moore JL, McClure EM, Koso-Thomas M, Hibberd PL. Rates and determinants of early initiation of breastfeeding and exclusive breast feeding at 42 days postnatal in six low and middle-income countries: A prospective cohort study. Reprod Health. 2015;12 Suppl 2:S10. doi: 10.1186/1742-4755-12-S2-S10. Epub 2015 Jun 8.
Dhaded SM, Somannavar MS, Vernekar SS, Goudar SS, Mwenche M, Derman R, Moore JL, Patel A, Pasha O, Esamai F, Garces A, Althabe F, Chomba E, Liechty EA, Hambidge K, Krebs NF, Berrueta M, Ciganda A, Hibberd PL, Goldenberg RL, McClure EM, Koso-Thomas M, Manasyan A, Carlo WA. Neonatal mortality and coverage of essential newborn interventions 2010 - 2013: a prospective, population-based study from low-middle income countries. Reprod Health. 2015;12 Suppl 2:S6. doi: 10.1186/1742-4755-12-S2-S6. Epub 2015 Jun 8.
Bauserman M, Lokangaka A, Thorsten V, Tshefu A, Goudar SS, Esamai F, Garces A, Saleem S, Pasha O, Patel A, Manasyan A, Berrueta M, Kodkany B, Chomba E, Liechty EA, Hambidge K, Krebs NF, Derman RJ, Hibberd PL, Althabe F, Carlo WA, Koso-Thomas M, Goldenberg RL, Wallace DD, McClure EM, Bose CL. Risk factors for maternal death and trends in maternal mortality in low- and middle-income countries: a prospective longitudinal cohort analysis. Reprod Health. 2015;12 Suppl 2:S5. doi: 10.1186/1742-4755-12-S2-S5. Epub 2015 Jun 8.
Marete I, Tenge C, Chemweno C, Bucher S, Pasha O, Ramadurg UY, Mastiholi SC, Chiwila M, Patel A, Althabe F, Garces A, Moore JL, Liechty EA, Derman RJ, Hibberd PL, Hambidge K, Goldenberg RL, Carlo WA, Koso-Thomas M, McClure EM, Esamai F. Lost to follow-up among pregnant women in a multi-site community based maternal and newborn health registry: a prospective study. Reprod Health. 2015;12 Suppl 2:S4. doi: 10.1186/1742-4755-12-S2-S4. Epub 2015 Jun 8.
Goudar SS, Stolka KB, Koso-Thomas M, Honnungar NV, Mastiholi SC, Ramadurg UY, Dhaded SM, Pasha O, Patel A, Esamai F, Chomba E, Garces A, Althabe F, Carlo WA, Goldenberg RL, Hibberd PL, Liechty EA, Krebs NF, Hambidge MK, Moore JL, Wallace DD, Derman RJ, Bhalachandra KS, Bose CL. Data quality monitoring and performance metrics of a prospective, population-based observational study of maternal and newborn health in low resource settings. Reprod Health. 2015;12 Suppl 2:S2. doi: 10.1186/1742-4755-12-S2-S2. Epub 2015 Jun 8.
Pasha O, Saleem S, Ali S, Goudar SS, Garces A, Esamai F, Patel A, Chomba E, Althabe F, Moore JL, Harrison M, Berrueta MB, Hambidge K, Krebs NF, Hibberd PL, Carlo WA, Kodkany B, Derman RJ, Liechty EA, Koso-Thomas M, McClure EM, Goldenberg RL. Maternal and newborn outcomes in Pakistan compared to other low and middle income countries in the Global Network's Maternal Newborn Health Registry: an active, community-based, pregnancy surveillance mechanism. Reprod Health. 2015;12 Suppl 2:S15. doi: 10.1186/1742-4755-12-S2-S15. Epub 2015 Jun 8.
Page CM, Patel A, Hibberd PL. Does smoke from biomass fuel contribute to anemia in pregnant women in Nagpur, India? A cross-sectional study. PLoS One. 2015 May 29;10(5):e0127890. doi: 10.1371/journal.pone.0127890. eCollection 2015.
Patel AB, Meleth S, Pasha O, Goudar SS, Esamai F, Garces AL, Chomba E, McClure EM, Wright LL, Koso-Thomas M, Moore JL, Saleem S, Liechty EA, Goldenberg RL, Derman RJ, Hambidge KM, Carlo WA, Hibberd PL. Impact of exposure to cooking fuels on stillbirths, perinatal, very early and late neonatal mortality - a multicenter prospective cohort study in rural communities in India, Pakistan, Kenya, Zambia and Guatemala. Matern Health Neonatol Perinatol. 2015 Jul 21;1:18. doi: 10.1186/s40748-015-0019-0. eCollection 2015.
Goudar SS, Carlo WA, McClure EM, Pasha O, Patel A, Esamai F, Chomba E, Garces A, Althabe F, Kodkany B, Sami N, Derman RJ, Hibberd PL, Liechty EA, Krebs NF, Hambidge KM, Buekens P, Moore J, Wallace D, Jobe AH, Koso-Thomas M, Wright LL, Goldenberg RL. The Maternal and Newborn Health Registry Study of the Global Network for Women's and Children's Health Research. Int J Gynaecol Obstet. 2012 Sep;118(3):190-3. doi: 10.1016/j.ijgo.2012.04.022. Epub 2012 Jun 26.

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
First Submitted: February 21, 2010
First Posted: February 23, 2010
Last Update Posted: December 30, 2016
Last Verified: November 2016

Keywords provided by NICHD Global Network for Women's and Children's Health:
Pregnancy
Maternal mortality
Neonatal mortality
Stillbirth
Maternal Near Miss
Maternal Cause of Death
Neonatal Cause of Death


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