Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
950000 participants
OBSERVATIONAL
2008-05-31
2030-05-31
Brief Summary
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Detailed Description
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A sub-study to the Maternal Newborn Health Registry will be conducted to understand the prevalence of COVID-19 among pregnant women, the association between COVID-19 and pregnancy outcomes, and the Knowledge, Attitudes, and Practices of pregnant women related to COVID-19 and its prevention during pregnancy. Women who consent to participation in the MNHR COVID sub-study will provide a blood specimen at or near delivery to be tested for COVID-19 antibodies. Four Global Network sites (Guatemala, Bangladesh, Nagpur India and Pakistan) will also collect and analyze blood specimen from participants during antenatal care visits.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregnant women
Pregnant women in the MNH cluster
There is no intervention associated with the parent MNHR study. For the MNHR COVID sub-study, participants will be asked to provide a blood specimen at or near delivery.
There is no intervention associated with the parent MNHR study
For the MNHR COVID sub-study, each woman will be asked to provide a blood specimen of approximately 3-5 cc at or near delivery (at delivery or 14 days after) to be tested for COVID-19 antibodies. The person collecting the specimen will be a trained member of the registry staff. The ZEUS ELISA SARS-CoV-2 IgG Test System will be used and run at each site. RTI International will provide central quality support of the analyses.
Male and Female Infants
Male and Female Infants delivered in the clusters
There is no intervention associated with the parent MNHR study. For the MNHR COVID sub-study, participants will be asked to provide a blood specimen at or near delivery.
There is no intervention associated with the parent MNHR study
For the MNHR COVID sub-study, each woman will be asked to provide a blood specimen of approximately 3-5 cc at or near delivery (at delivery or 14 days after) to be tested for COVID-19 antibodies. The person collecting the specimen will be a trained member of the registry staff. The ZEUS ELISA SARS-CoV-2 IgG Test System will be used and run at each site. RTI International will provide central quality support of the analyses.
Interventions
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There is no intervention associated with the parent MNHR study. For the MNHR COVID sub-study, participants will be asked to provide a blood specimen at or near delivery.
There is no intervention associated with the parent MNHR study
For the MNHR COVID sub-study, each woman will be asked to provide a blood specimen of approximately 3-5 cc at or near delivery (at delivery or 14 days after) to be tested for COVID-19 antibodies. The person collecting the specimen will be a trained member of the registry staff. The ZEUS ELISA SARS-CoV-2 IgG Test System will be used and run at each site. RTI International will provide central quality support of the analyses.
Eligibility Criteria
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Inclusion Criteria
* 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
* Opt out of consent to include data in the study
ALL
Yes
Sponsors
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NICHD Global Network for Women's and Children's Health
NETWORK
Responsible Party
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Principal Investigators
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Marion Koso-Thomas, MD
Role: STUDY_DIRECTOR
Center for Research for Mothers and Children (NICHD)
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Colorado Denver
Aurora, Colorado, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Boston University
Boston, Massachusetts, United States
Columbia University
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Virgina
Charlottesville, Virginia, United States
ICDDRB
Dhaka, , Bangladesh
Kinshasa School of Public Health
Kinshasa, , Democratic Republic of the Congo
Institute for Nutrition of Central America and Panama (INCAP)
Guatemala City, Departamento de Guatemala, Guatemala
Lata Medical Research Foundation
Nagpur, India, India
KLE Academy of Higher Education and Research
Belagavi, Karnataka, India
The Aga Khan University
Karachi, Pakistan, Pakistan
University Teaching Hospital
Lusaka, Zambia, Zambia
Countries
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Central Contacts
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Facility Contacts
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References
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Austad KE, Rao SR, Hibberd PL, Patel AB. Trends and determinants of the use of episiotomy in a prospective population-based registry from central India. BMC Pregnancy Childbirth. 2024 Sep 12;24(1):598. doi: 10.1186/s12884-024-06762-y.
Switchenko N, Shukla V, Mwenechanya M, Chomba E, Patel A, Hibberd PL, Ambalavanan N, Figueroa L, Mazariegos M, Krebs NF, Goudar SS, Derman R, Esamai F, Liechty EA, Bucher S, Saleem S, Goldenberg RL, Lokangaka A, Tshefu A, Bose CL, Koso-Thomas M, Tan S, Nolen T, McClure EM, Carlo WA. Neonatal Respiratory Support Utilization in Low- and Middle-Income Countries: A Registry-Based Observational Study. Neonatology. 2024;121(1):116-124. doi: 10.1159/000534777. Epub 2023 Dec 4.
Figueroa L, Harrison M, Mazariegos M, Goudar S, Kavi A, Derman R, Patel A, Das P, Hibberd PL, Saleem S, Naqvi F, Goldenberg RL, Haque R, Billah SM, Petri WA Jr, McClure EM, Tan S, Krebs NF. Maternal and perinatal outcomes of women with vaginal birth after cesarean section compared to repeat cesarean birth in select South Asian and Latin American settings of the global network for women's and children's health research. Matern Health Neonatol Perinatol. 2023 Nov 1;9(1):13. doi: 10.1186/s40748-023-00169-x.
Patel A, Bann CM, Thorsten VR, Rao SR, Lokangaka A, Tshefu Kitoto A, Bauserman M, Figueroa L, Krebs NF, Esamai F, Bucher S, Saleem S, Goldenberg RL, Chomba E, Carlo WA, Goudar S, Derman R, Koso-Thomas M, McClure E, Hibberd PL. Can the date of last menstrual period be trusted in the first trimester? Comparisons of gestational age measures from a prospective cohort study in six low-income to middle-income countries. BMJ Open. 2023 Sep 20;13(9):e067470. doi: 10.1136/bmjopen-2022-067470.
Marete I, Ekhaguere O, Bann CM, Bucher SL, Nyongesa P, Patel AB, Hibberd PL, Saleem S, Goldenberg RL, Goudar SS, Derman RJ, Garces AL, Krebs NF, Chomba E, Carlo WA, Lokangaka A, Bauserman M, Koso-Thomas M, Moore JL, McClure EM, Esamai F. Regional trends in birth weight in low- and middle-income countries 2013-2018. Reprod Health. 2020 Dec 17;17(Suppl 3):176. doi: 10.1186/s12978-020-01026-2.
Patel AB, Bann CM, Garces AL, Krebs NF, Lokangaka A, Tshefu A, Bose CL, Saleem S, Goldenberg RL, Goudar SS, Derman RJ, Chomba E, Carlo WA, Esamai F, Liechty EA, Koso-Thomas M, McClure EM, Hibberd PL. Development of the Global Network for Women's and Children's Health Research's socioeconomic status index for use in the network's sites in low and lower middle-income countries. Reprod Health. 2020 Dec 17;17(Suppl 3):193. doi: 10.1186/s12978-020-01034-2.
Pusdekar YV, Patel AB, Kurhe KG, Bhargav SR, Thorsten V, Garces A, Goldenberg RL, Goudar SS, Saleem S, Esamai F, Chomba E, Bauserman M, Bose CL, Liechty EA, Krebs NF, Derman RJ, Carlo WA, Koso-Thomas M, Nolen TL, McClure EM, Hibberd PL. Rates and risk factors for preterm birth and low birthweight in the global network sites in six low- and low middle-income countries. Reprod Health. 2020 Dec 17;17(Suppl 3):187. doi: 10.1186/s12978-020-01029-z.
Bauserman M, Thorsten VR, Nolen TL, Patterson J, Lokangaka A, Tshefu A, Patel AB, Hibberd PL, Garces AL, Figueroa L, Krebs NF, Esamai F, Nyongesa P, Liechty EA, Carlo WA, Chomba E, Goudar SS, Kavi A, Derman RJ, Saleem S, Jessani S, Billah SM, Koso-Thomas M, McClure EM, Goldenberg RL, Bose C. Maternal mortality in six low and lower-middle income countries from 2010 to 2018: risk factors and trends. Reprod Health. 2020 Dec 17;17(Suppl 3):173. doi: 10.1186/s12978-020-00990-z.
Goudar SS, Goco N, Somannavar MS, Kavi A, Vernekar SS, Tshefu A, Chomba E, Garces AL, Saleem S, Naqvi F, Patel A, Esamai F, Bose CL, Carlo WA, Krebs NF, Hibberd PL, Liechty EA, Koso-Thomas M, Nolen TL, Moore J, Iyer P, McClure EM, Goldenberg RL, Derman RJ. Institutional deliveries and stillbirth and neonatal mortality in the Global Network's Maternal and Newborn Health Registry. Reprod Health. 2020 Dec 17;17(Suppl 3):179. doi: 10.1186/s12978-020-01001-x.
Patel AB, Simmons EM, Rao SR, Moore J, Nolen TL, Goldenberg RL, Goudar SS, Somannavar MS, Esamai F, Nyongesa P, Garces AL, Chomba E, Mwenechanya M, Saleem S, Naqvi F, Bauserman M, Bucher S, Krebs NF, Derman RJ, Carlo WA, Koso-ThomasMcClure MEM, Hibberd PL. Evaluating the effect of care around labor and delivery practices on early neonatal mortality in the Global Network's Maternal and Newborn Health Registry. Reprod Health. 2020 Nov 30;17(Suppl 2):156. doi: 10.1186/s12978-020-01010-w.
Bauserman M, Nowak K, Nolen TL, Patterson J, Lokangaka A, Tshefu A, Patel AB, Hibberd PL, Garces AL, Figueroa L, Krebs NF, Esamai F, Liechty EA, Carlo WA, Chomba E, Mwenechanya M, Goudar SS, Ramadurg U, Derman RJ, Saleem S, Jessani S, Koso-Thomas M, McClure EM, Goldenberg RL, Bose C. The relationship between birth intervals and adverse maternal and neonatal outcomes in six low and lower-middle income countries. Reprod Health. 2020 Nov 30;17(Suppl 2):157. doi: 10.1186/s12978-020-01008-4.
McClure EM, Saleem S, Goudar SS, Garces A, Whitworth R, Esamai F, Patel AB, Tikmani SS, Mwenechanya M, Chomba E, Lokangaka A, Bose CL, Bucher S, Liechty EA, Krebs NF, Yogesh Kumar S, Derman RJ, Hibberd PL, Carlo WA, Moore JL, Nolen TL, Koso-Thomas M, Goldenberg RL. Stillbirth 2010-2018: a prospective, population-based, multi-country study from the Global Network. Reprod Health. 2020 Nov 30;17(Suppl 2):146. doi: 10.1186/s12978-020-00991-y.
Saleem S, Naqvi F, McClure EM, Nowak KJ, Tikmani SS, Garces AL, Hibberd PL, Moore JL, Nolen TL, Goudar SS, Kumar Y, Esamai F, Marete I, Patel AB, Chomba E, Mwenechanya M, Bose CL, Liechty EA, Krebs NF, Derman RJ, Carlo WA, Tshefu A, Koso-Thomas M, Siddiqi S, Goldenberg RL. Neonatal deaths in infants born weighing >/= 2500 g in low and middle-income countries. Reprod Health. 2020 Nov 30;17(Suppl 2):158. doi: 10.1186/s12978-020-01013-7.
Dhaded SM, Somannavar MS, Moore JL, McClure EM, Vernekar SS, Yogeshkumar S, Kavi A, Ramadurg UY, Nolen TL, Goldenberg RL, Derman RJ, Goudar SS. Neonatal deaths in rural Karnataka, India 2014-2018: a prospective population-based observational study in a low-resource setting. Reprod Health. 2020 Nov 30;17(Suppl 2):161. doi: 10.1186/s12978-020-01014-6.
Figueroa L, Garces A, Hambidge KM, McClure EM, Moore J, Goldenberg R, Krebs NF. Prevalence of clinically-evident congenital anomalies in the Western highlands of Guatemala. Reprod Health. 2020 Nov 30;17(Suppl 2):153. doi: 10.1186/s12978-020-01007-5.
McClure EM, Garces AL, Hibberd PL, Moore JL, Goudar SS, Saleem S, Esamai F, Patel A, Chomba E, Lokangaka A, Tshefu A, Haque R, Bose CL, Liechty EA, Krebs NF, Derman RJ, Carlo WA, Petri W, Koso-Thomas M, Goldenberg RL. The Global Network Maternal Newborn Health Registry: a multi-country, community-based registry of pregnancy outcomes. Reprod Health. 2020 Nov 30;17(Suppl 2):184. doi: 10.1186/s12978-020-01020-8.
Patel A, Pusdekar YV, Prakash AA, Simmons E, Waikar M, Rao SR, Hibberd PL. Trends and determinants of increasing caesarean sections from 2010 to 2013 in a prospective population-based registry in eastern rural Maharashtra, India. BMJ Open. 2019 Aug 5;9(8):e024654. doi: 10.1136/bmjopen-2018-024654.
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. doi: 10.1186/s12889-016-3688-3.
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.
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.
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(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(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(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(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(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(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(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(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(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(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.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
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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
Other Identifiers
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CP MNH
Identifier Type: -
Identifier Source: org_study_id
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