JNMC | Women’s and Children’s Health Research Unit
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India contributes to the greatest number of the 2.6 million stillbirths, 3.1 million neonatal deaths and the 342,900 maternal deaths that occur globally every year. The international community and the ministries of health are looking for evidence based health care strategies that can be implemented in low-resource community settings to make a significant impact on this alarming mortality burden. J N Medical College, Belgaum has taken a special initiative for improving the health status of the mothers and newborns in the north Karnataka region. In that noble endeavor, the year 1999 represents a significant landmark. Spurred by the encouragement of Dr Prabhakar Kore, MP, and the visionary Chairman of KLE Society, an academic collaboration was established with the University of Illinois at Chicago, USA. The major emphasis of the collaboration was to strengthen Medical Education as well as develop research capacity and clinical care services in Maternal and Child Health.
The National Institute of Child Health and Human Development of the National Institutes of Health, USA for the first time ever formed a Global Network for Women’s and Children’s Health Research in the year 2001. The objective of the Global Network is to implement community based research studies to improve maternal, neonatal, infant and early childhood health and accelerate the achievement of Millennium Development Goals 4 and 5 (of reducing maternal and newborn mortality) in low and middle income countries across Asia, Africa and Latin America. JNMC has the unique distinction of being selected as one of the sites of the research network. For realizing the Global Network mandate, JNMC established a Women’s and Children’s Health Research Unit in 2001. In fulfilling its mission, the JNMC Research Unit has forged a strong Public Private Partnership with the public sector health care system. Building on the expanded research capacity emanating from Global Network participation, JNMC has forged collaborations with nine Universities of the USA and two from Canada as well as other international not-for-profit organizations.
Over the past twelve years, JNMC’s multi-disciplinary research team has conducted a number of community based research projects with support from other NIH agencies, the World Health Organization, Geneva, the American Academy of Pediatrics, the International Atomic Energy Agency, the Thrasher Research Foundation, the Norwegian Agency for Development Cooperation (NORAD), the Laerdal Medical Foundation and the Bill and Melinda Gates Foundation. The research areas relate to: identifying strategies for preventing excessive bleeding during child birth; optimizing delivery practices of birth attendants; improving the skills of birth attendants for initiating newborn resuscitation in babies who fail to breathe spontaneously after birth; developing a home-to-hospital continuum of Emergency Obstetric and Newborn Care health system model through community participation and improvement of quality of health care services at hospitals; training community health workers like ASHAs to identify pregnant women with increased risk for preterm delivery and facilitating the administration of corticosteroids for reducing mortality among preterm low birth weight babies; promoting optimal childhood growth and development through home based education of families; and testing the effectiveness of nutritional supplementation prior to pregnancy on the growth and development of the baby. The site has pioneered a population based registry for tracking maternal and newborn health outcomes. The overarching intent of these research projects is to develop sustainable service delivery models for informing policy that could be scaled up programmatically by countries to meet MDGs 4 and 5. The results of these insightful research studies have had a profound impact at national and international levels in shaping public health policies.
Misoprostol-tablet, first tested in Belgaum district for preventing excessive bleeding in women after delivery, is now endorsed by the Government of India for community level prevention of postpartum bleeding. The study provided the critical evidence for the inclusion of misoprostol on the World Health Organization’s List of Essential Medicines for prevention of postpartum hemorrhage and stronger advocacy of misoprostol for PPH prevention by the United Nations’ Commission on Life-Saving Commodities for Maternal Health. It also prompted expansion of the registration and use of misoprostol for prevention of postpartum bleeding by the Ministries of Health of 21 countries. However, the skill of birth attendants in conducting delivery and management of the immediate postpartum period is a critical factor in determining the extent of blood loss after childbirth. Studies conducted by the JNMC Research Unit have demonstrated that simplified practices for managing the third stage of delivery, and training birth attendants for adopting them, are capable of improving the health outcomes of mothers.
Failure to breathe spontaneously at birth (birth asphyxia) is one of the leading causes of early newborn mortality. Inappropriate and unscientific resuscitation practices for reviving such babies are prevalent widely and contribute significantly to the high number of stillbirths and newborn deaths witnessed in our communities. Between 2005 and 2008, the ‘Global Network’ launched a major initiative of training community-based birth attendants in Neonatal Resuscitation for reducing early neonatal mortality in developing countries. The results of this “First Breath: Community Based Training and Intervention in Neonatal Resuscitation” research project led to the incorporation of the neonatal resuscitation training curriculum in the Basic Newborn Care & Resuscitation Program called “Navajat Shishu Suraksha Karyakram” (NSSK) program of the Government of India.
While ‘First Breath’ attempted reduction of early newborn mortality from birth asphyxia, it was speculated that the survivors may end up with varying degree of impaired neurological development. The burden on families and the communities assumes greater significance in view of the scarcity of supportive care available to children of rural population. The “Brain Research to Ameliorate Impaired Neurodevelopment: Home-based Intervention Trial (BRAIN HIT)” addressed this concern by testing the feasibility of a home based early intervention program on babies resuscitated from birth asphyxia in improving their physical, mental and social development. The BRAIN-HIT study findings demonstrate that simple home based strategies could be effective in reducing neurodevelopmental disabilities in young children from low and middle income countries.
Health care systems in many developing countries struggle to provide safe delivery by skilled birth attendants and necessary emergency obstetric and newborn care. While the Misoprostol study and First Breath project focused on reducing maternal and newborn deaths from specific causes, community-participatory approaches and health system strengthening are essential if the maternal and newborn mortality has to be reduced drastically. The Emergency Obstetric and Newborn Care study implemented by the JNMC Research Unit tested an integrated package of these strategies for improving pregnancy outcomes. The strategies included creating awareness in the communities for birth planning and hospital transport, birth attendant training for early recognition of pregnancy and newborn complications, and hospital staff training in the management of obstetric and neonatal emergencies. Although, this comprehensive, large-scale, multi-sector intervention did not result in the anticipated impact on pregnancy outcomes, the results were encouraging. Lessons learnt from this project suggest that achieving improvement in pregnancy outcomes in these settings will require substantially more obstetric and newborn care infrastructure and provider training and community mobilization alone will not be sufficient.
Recently, the Research Unit has completed two more major research projects aimed at reducing newborn mortality in Belgaum and Bagalkot districts. While the Antenatal Corticosteroid Trial involved training community health workers in over 150 villages to identify women at high risk for preterm delivery and reduce newborn mortality, the Helping Babies Breathe project trained over 1,200 birth attendants working in 25 public sector (District Hospital, Belgaum, 7 Taluka hospitals, 2 Community Health Centers and 15 Primary Health Centers) and 8 private sector hospitals of Belgaum district for newborn resuscitation. The strategies used in the research studies to-date have demonstrated positive impact on maternal and neonatal outcomes. It is hoped that these will be incorporated by the Ministry of Health for improving the health outcomes of mothers and newborns throughout the country.
Additionally, three new research projects have been initiated by the JNMC Research Unit during the year 2013. The PRE-EMPT Initiative of the Bill & Melinda Gates Foundation is implementing community level interventions for reducing maternal and new-born mortality from hypertensive disorders during pregnancy all over the world. J N Medical College, Belgaum is collaborating with S Nijalingappa Medical College, Bagalkot and University of British Columbia, Vancouver, Canada for implementing this project in Belgaum and Bagalkot districts. Dr Prabhakar Kore, Chancellor of KLE University and Chairman, KLE Society inaugurated the research project in Delhi on November 12, 2013. The inaugural function was attended by more than 100 leading public health researchers in the area of maternal health from 13 countries. Representatives of WHO, Geneva and ICMR, New Delhi were also present at the Inaugural Function. The second project – “Women First: Stree Sanjeevini” – study supported by NICHD Global Network and the Bill and Melinda Gates Foundation is aimed at assessing the effect of nutritional supplementation prior to pregnancy on newborn growth. A third research project funded by Thrasher Foundation – the Clindamycin Trial – focuses on the use of antibiotics for treating infection during pregnancy for reducing preterm births in rural areas. The results of these trials will likely have implications in shaping public health policy nationally and internationally.
Ms Kathleen Sebelius, Secretary of Health, heading the Department of Health and Human Services of the USA visited J N Medical College, Belgaum to observe the research activities conducted at the village level. Congratulating the JNMC research team for the outcomes in community based studies focused on women’s and children’s health, she lauded KLE for its commitment to improve the health status of rural India. On this glorious occasion, she lauded the leadership of Dr Prabhakar Kore and his encouragement to community based research for the benefit of rural women and children. She also gave a special invitation to the Hon’ble Chancellor Dr Prabhakar Kore and the members of the JNMC Research Unit to participate in a meeting of the Global Network in Washington held in June 2012. Acknowledging the outstanding research contribution of the research team, she reaffirmed the continued support of US Government for the next five years through 2018.
In order to strengthen the health care services in the north Karnataka region, the JNMC Research Unit has networked with S Nijalingappa Medical College of BVV Sangha, Bagalkot and Sri B M Patil Medical College of BLDE University, Bijapur. The Research Unit’s activities now encompass over 700 villages spread over the districts of Belgaum, Bijapur and Bagalkot and cover a population of over 20 lakhs. The scientific productivity of the research unit has been phenomenal. Over the past 12 years the Research Unit scientists have authored more than 50 scientific papers that have been published in internationally reputed biomedical journals like the Lancet, the New England Journal of Medicine and Pediatrics.
In conclusion, the JNMC Research Unit has made a humble effort at fulfilling its social responsibility towards improving the health of our mothers and children. But, it recognizes that a lot more needs to be done in the years to come if we have to ensure a safe childbirth and a healthy newborn in our communities. It earnestly desires that the entire community will join hands with it in this earnest endeavor.Dr Shivaprasad S Goudar MD MHPE Professor of Physiology & Research Coordinator, Women’s and Children’s Health Research Unit, KLE University’s J N Medical College, Belagavi – 590010. Karnataka, INDIA. E-Mail: email@example.com Tel (Work): +91 831 244 4194 Fax: +91 831 247 2891 Mobile: +91 94481 26371
- Tikmani SS, Ali SA, Saleem S, Bann CM, Mwenechanya M, Carlo WA, Figueroa L, Garces AL, Krebs NF, Patel A, Hibberd PL, Goudar SS, Derman RJ, Aziz A, Marete I, Tenge C, Esamai F, Liechty E, Bucher S, Moore JL, McClure EM, Goldenberg RL. Trends of antenatal care during pregnancy in low- and middle-income countries: Findings from the global network maternal and newborn health registry. Semin Perinatol. 2019 Mar 16. pii: S0146-0005(19)30045-X. doi: 10.1053/j.semperi.2019.03.020. [Epub ahead of print] Review. PMID: 31005357
- Magee LA, Sharma S, Nathan HL, Adetoro OO, Bellad MB, Goudar S, Macuacua SE, Mallapur A, Qureshi R, Sevene E, Sotunsa J, Valá A, Lee T, Payne BA, Vidler M, Shennan AH, Bhutta ZA, von Dadelszen P; CLIP Study Group. The incidence of pregnancy hypertension in India, Pakistan, Mozambique, and Nigeria: A prospective population-level analysis. PLoS Med. 2019 Apr 12;16(4):e1002783. doi: 10.1371/journal.pmed.1002783. eCollection 2019 Apr. PMID: 30978179
- Vousden N, Lawley E, Seed PT, Gidiri MF, Goudar S, Sandall J, Chappell LC, Shennan AH; CRADLE Trial Collaborative Group. Incidence of eclampsia and related complications across 10 low- and middle-resource geographical regions: Secondary analysis of a cluster randomised controlled trial. PLoS Med. 2019 Mar 29;16(3):e1002775. doi: 10.1371/journal.pmed.1002775. eCollection 2019 Mar. PMID: 30925157
- Vousden N, Lawley E, Nathan HL, Seed PT, Gidiri MF, Goudar S, Sandall J, Chappell LC, Shennan AH; CRADLE Trial Collaborative Group. Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial. Lancet Glob Health. 2019 Mar;7(3):e347-e356. doi: 10.1016/S2214-109X(18)30526-6. PMID: 30784635
- Hambidge KM, Westcott JE, Garcés A, Figueroa L, Goudar SS, Dhaded SM, Pasha O, Ali SA, Tshefu A, Lokangaka A, Derman RJ, Goldenberg RL, Bose CL, Bauserman M, Koso-Thomas M, Thorsten VR, Sridhar A, Stolka K, Das A, McClure EM, Krebs NF; Women First Preconception Trial Study Group. A multicountry randomized controlled trial of comprehensive maternal nutrition supplementation initiated before conception: the Women First trial. Am J Clin Nutr. 2019 Feb 1;109(2):457-469. doi: 10.1093/ajcn/nqy228. PMID: 30721941
- Parks S, Hoffman MK, Goudar SS, Patel A, Saleem S, Ali SA, Goldenberg RL, Hibberd PL, Moore J, Wallace D, McClure EM, Derman RJ. Maternal anaemia and maternal, fetal, and neonatal outcomes in a prospective cohort study in India and Pakistan. BJOG. 2019 May;126(6):737-743. doi: 10.1111/1471-0528.15585. Epub 2019 Jan 24. PMID: 30554474
- Duffy CR, Moore JL, Saleem S, Tshefu A, Bose CL, Chomba E, Carlo WA, Garces AL, Krebs NF, Hambidge KM, Goudar SS, Derman RJ, Patel A, Hibberd PL, Esamai F, Liechty EA, Wallace DD, McClure EM, Goldenberg RL; NICHD Global Network for Women’s and Children’s Health Research. Malpresentation in low- and middle-income countries: Associations with perinatal and maternal outcomes in the Global Network. Acta Obstet Gynecol Scand. 2019 Mar;98(3):300-308. doi: 10.1111/aogs.13502. Epub 2018 Dec 20. PMID: 30414270
- Harrison MS, Saleem S, Ali S, Pasha O, Chomba E, Carlo WA, Garces AL, Krebs NF, Hambidge KM, Goudar SS, Dhaded SM, Kodkany B, Derman RJ, Patel A, Hibberd PL, Esamai F, Liechty EA, Tshefu A, Lokangaka A, Bauserman M, Bose CL, Althabe F, Belizan JM, Buekens P, Moore JL, Wallace DD, Miodovnik M, Koso-Thomas M, McClure EM, Goldenberg RL. A Prospective, Population-Based Study of Trends in Operative Vaginal Delivery Compared to Cesarean Delivery Rates in Low- and Middle-Income Countries, 2010-2016. Am J Perinatol. 2019 Jun;36(7):730-736. doi: 10.1055/s-0038-1673656. Epub 2018 Oct 29. PMID: 30372772
- Nathan HL, Vousden N, Lawley E, de Greeff A, Hezelgrave NL, Sloan N, Tanna N, Goudar SS, Gidiri MF, Sandall J, Chappell LC, Shennan AH. Development and evaluation of a novel Vital Signs Alert device for use in pregnancy in low-resource settings. BMJ Innov. 2018 Oct;4(4):192-198. doi: 10.1136/bmjinnov-2017-000235. Epub 2018 Sep 19. PMID: 30319784
- Goldenberg RL, Muhe L, Saleem S, Dhaded S, Goudar SS, Patterson J, Nigussie A, McClure EM. Criteria for assigning cause of death for stillbirths and neonatal deaths in research studies in low-middle income countries. J Matern Fetal Neonatal Med. 2019 Jun;32(11):1915-1923. doi: 10.1080/14767058.2017.1419177. Epub 2018 Aug 23. PMID: 30134756
- Belizán JM, Minckas N, McClure EM, Saleem S, Moore JL, Goudar SS, Esamai F, Patel A, Chomba E, Garces AL, Althabe F, Harrison MS, Krebs NF, Derman RJ, Carlo WA, Liechty EA, Hibberd PL, Buekens PM, Goldenberg RL. An approach to identify a minimum and rational proportion of caesarean sections in resource-poor settings: a global network study. Lancet Glob Health. 2018 Aug;6(8):e894-e901. doi: 10.1016/S2214-109X(18)30241-9. PMID: 30012270
- Widmer M, Piaggio G, Nguyen TMH, Osoti A, Owa OO, Misra S, Coomarasamy A, Abdel-Aleem H, Mallapur AA, Qureshi Z, Lumbiganon P, Patel AB, Carroli G, Fawole B, Goudar SS, Pujar YV, Neilson J, Hofmeyr GJ, Su LL, Ferreira de Carvalho J, Pandey U, Mugerwa K, Shiragur SS, Byamugisha J, Giordano D, Gülmezoglu AM; WHO CHAMPION Trial Group. Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth. N Engl J Med. 2018 Jun 27. doi: 10.1056/NEJMoa1805489. PMID: 29949473
- Katageri G, Charantimath U, Joshi A, Vidler M, Ramadurg U, Sharma S, Bannale S, Payne BA, Rakaraddi S, Karadiguddi C, Mungarwadi G, Kavi A, Sawchuck D, Derman R, Goudar S, Mallapur A, Bellad M, Magee LA, Qureshi R, von Dadelszen P; Community Level Interventions for Pre-eclampsia (CLIP) India Feasibility Working Group. Availability and use of magnesium sulphate at health care facilities in two selected districts of North Karnataka, India. Reprod Health. 2018 Jun 22;15(Suppl 1):91. doi: 10.1186/s12978-018-0531-6. PMID: 29945665
- Charanthimath U, Vidler M, Katageri G, Ramadurg U, Karadiguddi C, Kavi A, Joshi A, Mungarwadi G, Bannale S, Rakaraddi S, Sawchuck D, Qureshi R, Sharma S, Payne BA, von Dadelszen P, Derman R, Magee LA, Goudar S, Mallapur A, Bellad M; and the Community Level Interventions for Pre-eclampsia (CLIP) India Feasibility Working Group, Bhutta Z, Naik S, Mulla A, Kamle N, Dhamanekar V, Drebit SK, Kariya C, Lee T, Li J, Lui M, Khowaja AR, Tu DK, Revankar A. The feasibility of task-sharing the identification, emergency treatment, and referral for women with pre-eclampsia by community health workers in India. Reprod Health. 2018 Jun 22;15(Suppl 1):101. doi: 10.1186/s12978-018-0532-5. PMID: 29945662
- Mastiholi SC, Somannavar MS, Vernekar SS, Yogesh Kumar S, Dhaded SM, Herekar VR, Lander RL, Hambidge MK, Krebs NF, Goudar SS. Food insecurity and nutritional status of preconception women in a rural population of North Karnataka, India. Reprod Health. 2018 Jun 22;15(Suppl 1):90. doi: 10.1186/s12978-018-0535-2. PMID: 29945660
- Theunissen FJ, Chinery L, Pujar YV. Current research on carbetocin and implications for prevention of postpartum haemorrhage. Reprod Health. 2018 Jun 22;15(Suppl 1):94. doi: 10.1186/s12978-018-0529-0. Review. PMID: 29945640
- McClure EM, Saleem S, Goudar SS, Dhaded S, Guruprasad G, Kumar Y, Tikmani SS, Kadir M, Raza J, Yasmin H, Moore JL, Kim J, Bann C, Parlberg L, Aceituno A, Carlo WA, Silver RM, Lamberti L, Patterson J, Goldenberg RL. The project to understand and research preterm pregnancy outcomes and stillbirths in South Asia (PURPOSe): a protocol of a prospective, cohort study of causes of mortality among preterm births and stillbirths. Reprod Health. 2018 Jun 22;15(Suppl 1):89. doi: 10.1186/s12978-018-0528-1. PMID: 29945651
- 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. PMID: 29945647
- 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. PMID: 29945645
- Bellad MB, Hoffman MK, Mallapur AA, Charantimath US, Katageri GM, Ganachari MS, Kavi A, Ramdurg UY, Bannale SG, Revankar AP, Sloan NL, Kodkany BS, Goudar SS, Derman RJ. Clindamycin to reduce preterm birth in a low resource setting: a randomised placebo-controlled clinical trial. BJOG. 2018 May 22. doi: 10.1111/1471-0528.15290. PMID: 29790266
- Vousden N, Lawley E, Nathan HL, Seed PT, Brown A, Muchengwa T, Charantimath U, Bellad M, Gidiri MF, Goudar S, Chappell LC, Sandall J, Shennan AH; CRADLE Trial Collaborative Group. Evaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings: a mixed method feasibility study for the CRADLE-3 trial. BMC Pregnancy Childbirth. 2018 Apr 27;18(1):115. doi: 10.1186/s12884-018-1737-x. PMID: 29703254
- Nathan HL, Duhig K, Vousden N, Lawley E, Seed PT, Sandall J, Bellad MB, Brown AC, Chappell LC, Goudar SS, Gidiri MF, Shennan AH; CRADLE-3 Trial Collaboration Group. Evaluation of a novel device for the management of high blood pressure and shock in pregnancy in low-resource settings: study protocol for a stepped-wedge cluster-randomised controlled trial (CRADLE-3 trial). Trials. 2018 Mar 27;19(1):206. doi: 10.1186/s13063-018-2581-z. PMID: 29587875
- Short VL, Geller SE, Moore JL, McClure EM, Goudar SS, Dhaded SM, Kodkany BS, Saleem S, Naqvi F, Pasha O, Goldenberg RL, Patel AB, Hibberd PL, Garces AL, Koso-Thomas M, Miodovnik M, Wallace DD, Derman RJ; The Relationship between Body Mass Index in Pregnancy and Adverse Maternal, Perinatal, and Neonatal Outcomes in Rural India and Pakistan. Am J Perinatol. 2018 Jan 24. doi: 10.1055/s-0037-1621733. [Epub ahead of print] PMID: 29365329
- Pasha O, McClure EM, Saleem S, Sunder S, Lokangaka A, Tshefu A, Bose CL, Bauserman M, Mwenechanya M, Chomba E, Carlo WA, Garces AL, Figueroa L, Hambidge KM, Krebs NF, Goudar S, Kodkany BS, Dhaded S, Derman RJ, Patel A, Hibberd PL, Esamai F, Tenge C, Liechty EA, Moore JL, Wallace DD, Koso-Thomas M, Miodovnik M, Goldenberg RL.; A Prospective Cause of Death Classification System for Maternal Deaths in Low and Middle-Income Countries: Results from the Global Network Maternal Newborn Health Registry. BJOG. 2017 Nov 1. doi: 10.1111/1471-0528.15011. [Epub ahead of print]; PMID: 29094456
- K Michael Hambidge, Nancy F Krebs, Ana Garcés, Jamie E Westcott, Lester Figueroa, Shivaprasad S Goudar, Sangappa Dhaded, Omrana Pasha, Sumera Aziz Ali, Antoinette Tshefu, Adrien Lokangaka, Vanessa R Thorsten, Abhik Das, Kristen Stolka, Elizabeth M McClure, Rebecca L Lander, Carl L Bose, Richard J Derman, Robert L Goldenberg, Melissa Bauserman; Anthropometric indices for non-pregnant women of childbearing age differ widely among four low-middle income populations; BMC Public Health. 2017 Jul 24;18(1):45. doi: 10.1186/s12889-017-4509-z. PMID: 28738791
- Goldenberg RL, Saleem S, Ali S, Moore JL, Lokangako A, Tshefu A, Mwenechanya M, Chomba E, Garces A, Figueroa L, Goudar S, Kodkany B, Patel A, Esamai F, Nsyonge P, Harrison MS, Bauserman M, Bose CL, Krebs NF, Hambidge KM, Derman RJ, Hibberd PL, Liechty EA, Wallace DD, Belizan JM, Miodovnik M, Koso-Thomas M, Carlo WA, Jobe AH, McClure EM. Maternal near miss in low-resource areas. Int J Gynaecol Obstet. 2017 May 17. doi: 10.1002/ijgo.12219. [Epub ahead of print] PMID: 28513837
- Hoffman MK, Goudar SS, Kodkany BS, Goco N, Koso-Thomas M, Miodovnik M, McClure EM, Wallace DD, Hemingway-Foday JJ, Tshefu A, Lokangaka A, Bose CL, Chomba E, Mwenechanya M, Carlo WA, Garces A, Krebs NF, Hambidge KM, Saleem S, Goldenberg RL, Patel A, Hibberd PL, Esamai F, Liechty EA, Silver R, Derman RJ. A description of the methods of the aspirin supplementation for pregnancy indicated risk reduction in nulliparas (ASPIRIN) study. BMC Pregnancy Childbirth. 2017 May 3;17(1):135. doi: 10.1186/s12884-017-1312-x. PMID: 28468653
- Rebecca L. Lander, K. Michael Hambidge, Nancy F. Krebs, Jamie E. Westcott, Ana Garces, Lester Figueroa, Gabriela Tejeda, Adrien Lokangaka, Tshilenge S. Diba, Manjunath S. Somannavar, Ranjitha Honnayya, Sumera A. Ali, Umber S. Khan, Elizabeth M. McClure, Vanessa R. Thorsten, Kristen B. Stolka & For the Women First Preconception Nutrition Trial Group (2017); Repeat 24-hour recalls and locally developed food composition databases: a feasible method to estimate dietary adequacy in a multi-site preconception maternal nutrition RCT, Food & Nutrition Research, 61:1, 1311185, DOI: 10.1080/16546628.2017.1311185
- Hoffman MK, Bellad MB, Charantimath US, Kavi A, Nagmoti JM, Nagmoti MB, Mallapur AA, Katageri GM, Ramadurg UY, Bannale SG, Revankar AP, Ganachari MS, Derman RJ, Goudar SS; A Comparison of Colorimetric Assessment of Vaginal pH with Nugent Score for the Detection of Bacterial Vaginosis; Infect Dis Obstet Gynecol. 2017;2017:1040984. doi: 10.1155/2017/1040984. Epub 2017 Feb 15. PMID: 28293099
- Garces AL, McClure EM, Pérez W, Hambidge KM, Krebs NF, Figueroa L, Bose CL, Carlo WA, Tenge C, Esamai F, Goudar SS, Saleem S, Patel AB, Chiwila M, Chomba E, Tshefu A, Derman RJ, Hibberd PL, Bucher S, Liechty EA, Bauserman M, Moore JL, Koso-Thomas M, Miodovnik M, Goldenberg RL; The Global Network Neonatal Cause of Death algorithm for low-resource settings. Acta Paediatr. 2017 Feb 27. doi: 10.1111/apa.13805. [Epub ahead of print] PMID: 28240381
- McClure EM, Garces A, Saleem S, Moore JL, Bose CL, Esamai F, Goudar SS, Chomba E, Mwenechanya M, Pasha O, Tshefu A, Patel A, Dhaded SM, Tenge C, Marete I, Bauserman M, Sunder S, Kodkany BS, Carlo WA, Derman RJ, Hibberd PL, Liechty EA, Hambidge KM, Krebs NF, Koso-Thomas M, Miodovnik M, Wallace DD, Goldenberg RL; Global Network for Women’s and Children’s Health Research: probable causes of stillbirth in low- and middle-income countries using a prospectively defined classification system. BJOG. 2017 Jan 31. doi: 10.1111/1471-0528.14493. [Epub ahead of print] PMID: 28139875
- Harrison MS, Pasha O, Saleem S, Ali S, Chomba E, Carlo WA, Garces AL, Krebs NF, Hambidge KM, Goudar SS, Kodkany B, Dhaded S, Derman RJ, Patel A, Hibberd PL, Esamai F, Liechty EA, Moore JL, Wallace D, McClure EM, Miodovnik M, Koso-Thomas M, Belizan J, Goldenberg RL. A prospective study of maternal, fetal, and neonatal outcomes in the setting of cesarean section in low- and middle-income countries. Acta Obstet Gynecol Scand. 2017 Jan 20. doi: 10.1111/aogs.13098. [Epub ahead of print] PMID:28107771
- Bellad MB, Vidler M, Honnungar NV, Mallapur A, Ramadurg U, Charanthimath U, Katageri G, Bannale S, Kavi A, Karadiguddi C, Sharma S, Lee T, Li J, Payne B, Magee L, von Dadelszen P, Derman R, Goudar SS; CLIP Working Group; Maternal and Newborn Health in Karnataka State, India: The Community Level Interventions for Pre-Eclampsia (CLIP) Trial’s Baseline Study Results. PLoS One. 2017 Jan 20;12(1):e0166623. doi: 10.1371/journal.pone.0166623. PMID:28107350
- Bang A, Patel A, Bellad R, Gisore P, Goudar SS, Esamai F, Liechty EA, Meleth S, Goco N, Niermeyer S, Keenan W, Kamath-Rayne BD, Little GA, Clarke SB, Flanagan VA, Bucher S, Jain M, Mujawar N, Jain V, Rukunga J, Mahantshetti N, Dhaded S, Bhandankar M, McClure EM, Carlo WA, Wright LL, Hibberd PL.Helping Babies Breathe (HBB) training: What happens to knowledge and skills over time?; BMC Pregnancy Childbirth. 2016 Nov 22;16(1):364. PMID:27875999
- Ramadurg U, Vidler M, Charanthimath U, Katageri G, Bellad M, Mallapur A, Goudar S, Bannale S, Karadiguddi C, Sawchuck D, Qureshi R, von Dadelszen P, Derman R; Community Level Interventions for Pre-eclampsia (CLIP) India Feasibility Working Group; Community health worker knowledge and management of pre-eclampsia in rural Karnataka State, India.Reprod Health. 2016 Sep 30;13(Suppl 2):113.PMID: 27719678
- Chomba E, Carlo WA, Goudar SS, Jehan I, Tshefu A, Garces A, Parida S, Althabe F, McClure EM, Derman RJ, Goldenberg RL, Bose C, Krebs NF, Panigrahi P, Buekens P, Wallace D, Moore J, Koso-Thomas M, Wright LL; First Breath Study Group.Effects of Essential Newborn Care Training on Fresh Stillbirths and Early Neonatal Deaths by Maternal Education.Neonatology. 2016 Aug 20;111(1):61-67. [Epub ahead of print]PMID: 27544512
- Bellad RM, Bang A, Carlo WA, McClure EM, Meleth S, Goco N, Goudar SS, Derman RJ, Hibberd PL, Patel A, Esamai F, Bucher S, Gisore P, Wright LL; HBB Study Group. A pre-post study of a multi-country scale up of resuscitation training of facility birth attendants: does Helping Babies Breathe training save lives?BMC Pregnancy Childbirth. 2016 Aug 15;16(1):222. doi: 10.1186/s12884-016-0997-6. PMID: 27527831
- Asif Raza Khowaja, Rahat Najam Qureshi, Diane Sawchuck, Olufemi T. Oladapo, Olalekan O. Adetoro, Elizabeth A. Orenuga, Mrutyunjaya Bellad, Ashalata Mallapur, Umesh Charantimath, Esperança Sevene, Khátia Munguambe5, Helena Edith Boene, Marianne Vidler, Zulfiqar A. Bhutta, Peter von Dadelszen and CLIP Working Group. The feasibility of community level interventions for pre-clampsia in South Asia and Sub-Saharan Africa: a mixed-methods design. Reproductive Health 2016, 13 (Suppl 1):56, DOI 10.1186/s12978-016-0133-0
- Marianne Vidler, Umesh Ramadurg, Umesh Charantimath, Geetanjali Katageri, Chandrashekhar Karadiguddi, Diane Sawchuck, Rahat Qureshi, Shafik Dharamsi, Anjali Joshi, Peter von Dadelszen, Richard Derman, Mrutyunjaya Bellad, Shivaprasad Goudar, Ashalata Mallapur and for the Community Level Interventions for Pre-eclampsia (CLIP) India Feasibility Working Group. Utilization of maternal health care services and their determinants in Karnataka State, India. Reproductive Health 2016, 13(Suppl 1):37, DOI 10.1186/s12978-016-0138-8
- Marianne Vidler, Umesh Charantimath, Geetanjali Katageri, Umesh Ramadurg, Chandrashekhar Karadiguddi, Diane Sawchuck, Rahat Qureshi, Shafik Dharamsi, Peter von Dadelszen, Richard Derman, Shivaprasad Goudar, Ashalata Mallapur, Mrutyunjaya Bellad and for the Community Level Interventions for Pre-eclampsia (CLIP) India Feasibility Working Group. Community perceptions of pre-eclampsia in rural Karnataka State, India: a qualitative study. Reproductive Health 2016, 13 (Suppl 1):35 DOI 10.1186/s12978-016-0137-9
- Goldenberg RL, Thorsten VR, Althabe F, Saleem S, Garces A, Carlo WA, Pasha O, Chomba E, Goudar S, Esamai F, Krebs NF, Derman RJ, Liechty EA, Patel A, Hibberd PL, Buekens PM, Koso-Thomas M, Miodovnik M, Jobe AH, Wallace DD, Belizán JM, McClure EM. The global network antenatal corticosteroids trial: impact on stillbirth. Reprod Health. 2016 Jun 2;13(1):68. doi: 10.1186/s12978-016-0174-4. PMID: 27255082 PMCID: PMC4891888
Completed Research Protocols
- “Preconception Maternal Nutrition: A randomized trial” of the Global Network for Women’s and Children’s Health Research in Collaboration with the Bill and Melinda Gates Foundation (December 2012 – April 2019)
- “Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)” funded by the Global Network for Women’s and Children’s Health Research of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, USA (May 2015 to April 2019)
- “The CLIP (Community Level Interventions for Pre- Eclampsia) Cluster Randomized Controlled Trial” in collaboration with University of British Columbia, Vancouver BC, Canada with funding from Bill and Melinda Gates Foundation, USA, (September 2012 to June 2018)
- “Evaluation of the introduction of a novel device in the management of hypertension and shock in pregnancy in low-resource settings” in collaboration with King’s College, London co-funded by UK Medical Research Council and Department of Biotechnology, Govt. of India (July 2015 to March 2018)
- “A phase III, randomized, double- blind, active, controlled, multinational, multicenter, non-inferiority trial using carbetocin room temperature stable (RTS) for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally”- funded by Department of Reproductive Health & Research, World Health Organization, Geneva (July 2014 – June 2017)
- “Clindamycin to reduce preterm birth in low resource setting: A randomized placebo controlled trial” in collaboration with Christiana Care Health Services, USA with funding from Thrasher Research Fund, USA, (March 2012 – March 2016)
- “Evaluation of HELPING BABIES BREATHE in Belgaum, Kenya and Nagpur: Does implementation of HELPING BABIES BREATHE Save Lives?” project, funded by National Institute of Child Health and Human Development and Laerdal Foundation and Norwegian Agency for Development Cooperation (Norad) (January 2012-October 2013)
- “Antenatal Corticosteroids Trial in Preterm Births to Increase Neonatal Survival in Developing Countries (ACT) in Belgaum District, Karnataka, India” funded by National Institute of Child Health and Human Development, National Institutes of Health, USA. (September 2011 – October 2013)
- “Two community strategies comparing use of misoprostol for early treatment/secondary prevention to primary prevention for postpartum hemorrhage: a randomized cluster non-inferiority study in Bijapur district, Karnataka, India” in collaboration with Gynuity Health Projects, New York, USA and University of Illinois at Chicago, and University of California at San Francisco with funding from Bill and Melinda Gates Foundation, USA (January 2011 to August 2013)
- “Zinc and Iron bioavailability from bio-fortified pearl millet” in collaboration with University of Colorado Health Sciences Center, USA and sponsored by International Atomic Energy Agency, Vienna. (May 2008 – September 2012)
- “Pilot study of an Indicator to Measure Intrapartum Stillbirth and Immediate Neonatal Death” project, funded by National Institute of Child Health and Human Development and Engender Health and Maternal Health Task Force, (June 2011 – February 2012)
- “Evaluation of an Emergency Obstetrics and Newborn Care Intervention Package to Reduce Adverse Pregnancy Outcomes in Low Resource Settings (The EmONC Trial)” at 20 Primary Health Center Areas of Belgaum District ” funded by National Institute of Child Health and Human Development, National Institutes of Health, USA. (February 2009 – September 2011)
- “Brain Research to Ameliorate Impaired Neurodevelopment: Home-based Intervention Trial (BRAIN HIT)” funded by The National Institute of Child Health and Human Development (NICHD) and The National Institute of Neurological Disorders and Stroke (NINDS) Fogarty International Center. (August 2006 – September 2011)
- “Safe Childbirth Checklist” – Single Site Pilot Study, funded by The Children Investment Fund Foundation, USA. In collaboration with Harvard School of Public Health, Boston, USA. (July 2010 – December 2010)
- “A Comparison of Two Iron Doses on Zinc Absorption from Sprinkles as Micronutrient Supplement” in collaboration with University of Colorado Health Sciences Center and sponsored by International Atomic Energy Agency, Vienna (October 2007 – September 2008)
- “Field Implementation of the Helping Babies Breathe Initiative in Belgaum, Karnataka INDIA” funded by Global Implementation Task Force of American Academy of Pediatrics, USA, in collaboration with University of Calgary, Canada (August 2009 – June 2011)
- “Active Management of the Third Stage of Labour without Controlled Cord Traction: A Randomized Non-Inferiority Controlled Trial” funded by RHR Division of World Health Organization, Geneva, Switzerland (March 2008 – February 2010)
- “HIV – Cervical Cancer Prevention Research Project” NIH-ICMR funded Indo-US collaborative research grant for Vanderbilt University and the National AIDS Research Institute, Pune Consortium. (October 2007-September 2009)
- “A Global Network Study To Estimate Gestational Age By Fundal Height – Tape Study” funded by National Institute of Child Health and Human Development, National Institutes of Health, USA. (September 2007 – August 2008)
- First Breath: Community-based Training and Intervention in Neonatal Resuscitation, funded by National Institute of Child Health and Human Development and National Institutes of Health, USA. (January 2005 – April 2008)
- “Community-based Survey of Tobacco Use among pregnant women at 10 Primary Health Center Areas of Belgaum District”, funded by National Institute of Child Health and Human Development, National Institutes of Health, USA, National Cancer Institute. (November 2004 – February 2005)
- “A Randomized placebo-controlled trial of prophylactic misoprostol for prevention of postpartum haemorrhage at four primary health center areas of Belgaum District, Karnataka” funded by National Institute of Child Health and Human Development, National Institutes of Health, USA. (May 2001 – April 2006)
Ongoing Research Protocols
- “Prevention of Maternal and Neonatal Death/Infections With a Single Oral Dose of Azithromycin in Women in Labor (in Low- and Middle-income Countries): a Randomized Controlled Trial” funded by the Global Network for Women’s and Children’s Health Research of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, USA (May 2019 to April 2022)
- “Performance, Safety and Efficacy of a New Cryotherapy Device for Cervical Dysplasia in Low and Middle Income Countries” project in collaboration with Johns Hopkins Medical Institutions, Karnataka Institute of Medical Sciences, Hubballi and The Karnatak Cancer Therapy and Research Institute and funded by National Institute of Health/National Cancer Institute (NIH/NCI), USA (May 2019 to April 2021)
- “Low-birthweight Infant Feeding Exploration (LIFE)” project in collaboration with Ariadne Labs/Harvard T.H. Chan School of Public Health, Boston, MA and funded by Bill & Melinda Gates Foundation (November 2018 to October 2020)
- “CRADLE-4: Can Reduction of Adverse pregnancy outcomes occur with planned DeLivery vs. Expectant management in pre-eclampsia?” in collaboration with King’s College, London co-funded by UK Medical Research Council and Department of Biotechnology, Govt. of India (October 2018 to September 2021)
- “Prevalence and outcomes of abnormal continuous wave Doppler flow indices in unselected obstetric populations in low- and middle income countries: The Umbiflow™ International Study (A65924)” Sponsored by World Health Organization, Geneva. (August 2018 to July 2019)
- “Study of Cause of Death among Preterm Birth: Asia” in collaboration with RTI International, USA and J J M Medical College Davangere with funding from Bill & Melinda Gates Foundation, USA (November 2017 – October 2020)
- “Breastfeeding Education Support Tool for Baby (BEST4Baby)” funded by Fogarty International Center, National Institutes of Health, USA (October 2017 – September 2020)
- “The WHO ACTION (Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns) Trials:”
- a. WHO ACTION-I TRIAL – A65913: A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries to improve newborn outcomes.
- b. WHO ACTION-II TRIAL – A65916: A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, randomized trial of antenatal corticosteroids for women at risk of imminent birth in the late preterm period in hospitals in low-resource countries to improve newborn outcomes.
- Sponsored by World Health Organization, Geneva from June 2017 to May 2019
- “Maternal and Newborn Health Registry (MNH Registry)”, funded by the Global Network for Women’s and Children’s Health Research of the National Institute of Child Health and Human Development, USA (January 2008 – April 2023)