Maternal Newborn Health Registry - Full Text View

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:

MedlinePlus related topics: Stillbirth

U.S. FDA Resources

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 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


Ages Eligible for Study:	Child, Adult, Senior
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:

The Global Network for Women's and Children's Health Research website contains information for the MNH Registry as well as other Global Network studies This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

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

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.

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
Study First Received:	February 21, 2010
Last Updated:	April 18, 2016
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 September 23, 2016

Maternal Newborn Health Registry (MNH)