Maternal Newborn Health Registry (MNH)

Tracking Information
First Submitted Date	February 21, 2010
First Posted Date	February 23, 2010
Last Update Posted Date	April 4, 2018
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	Complete list of historical versions of study NCT01073475 on ClinicalTrials.gov Archive Site
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 Outcome Measures	Not Provided
Original Other 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 *	Patel A, Prakash AA, Das PK, Gupta S, Pusdekar YV, Hibberd PL. Maternal anemia and underweight as determinants of pregnancy outcomes: cohort study in eastern rural Maharashtra, India. BMJ Open. 2018 Aug 8;8(8):e021623. doi: 10.1136/bmjopen-2018-021623.; Saleem S, Tikmani SS, McClure EM, Moore JL, Azam SI, Dhaded SM, Goudar SS, Garces A, Figueroa L, Marete I, Tenge C, Esamai F, Patel AB, Ali SA, Naqvi F, Mwenchanya M, Chomba E, Carlo WA, Derman RJ, Hibberd PL, Bucher S, Liechty EA, Krebs N, Michael Hambidge K, Wallace DD, Koso-Thomas M, Miodovnik M, Goldenberg RL. Trends and determinants of stillbirth in developing countries: results from the Global Network's Population-Based Birth Registry. Reprod Health. 2018 Jun 22;15(Suppl 1):100. doi: 10.1186/s12978-018-0526-3.; Dhaded SM, Somannavar MS, Jacob JP, McClure EM, Vernekar SS, Yogesh Kumar S, Kavi A, Ramadurg UY, Moore JL, Wallace DP, Derman RJ, Goldenberg RL, Goudar SS. Early pregnancy loss in Belagavi, Karnataka, India 2014-2017: a prospective population-based observational study in a low-resource setting. Reprod Health. 2018 Jun 22;15(Suppl 1):95. doi: 10.1186/s12978-018-0525-4.; Patel A, Prakash AA, Pusdekar YV, Kulkarni H, Hibberd P. Detection and risk stratification of women at high risk of preterm birth in rural communities near Nagpur, India. BMC Pregnancy Childbirth. 2017 Sep 19;17(1):311. doi: 10.1186/s12884-017-1504-4.; Patel AB, Prakash AA, Raynes-Greenow C, Pusdekar YV, Hibberd PL. Description of inter-institutional referrals after admission for labor and delivery: a prospective population based cohort study in rural Maharashtra, India. BMC Health Serv Res. 2017 May 19;17(1):360. doi: 10.1186/s12913-017-2302-4.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Recruiting
Estimated Enrollment; (submitted: December 29, 2016)	600000
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: Marion Koso-Thomas, MD 301-435-6873 marion.koso-thomas@nih.gov Contact: Elizabeth McClure, PHD 919-316-3773 mcclure@rti.org
Listed Location Countries	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