JNMC Women’s & Childern’s Health Research Unit
JNMC Women’s & Childern’s Health Research Unit
JNMC Women’s and Children’s Health Research Unit’s Community Based Research Initiatives for Reducing Maternal and Newborn Mortality in North Karnataka
The Women’s and Children’s Health Research Unit (WCHRU) established in 2001, is a unique research centre of excellence at J N Medical College, KLE Academy of Higher Education and Research, Belagavi conducting academic clinical trials focused on women and children. The unit has been funded by National Institute of Child Health and Human Development, USA Global Network initiative since the inception of the network in 2001. JNMC is one of the six among the ten sites to be re-funded as a “Global Network Site for Women’s and Children’s Health Research” consecutively for the Fifth Cycle of funding since 2001 through 2030. The research unit is designated as “WHO Collaborating Center for Research in Maternal and Perinatal Health” since 2019; “ICMR Centre for Clinical Trials” in 2021 and “ICMR- Collaborating Centre of Excellence” in recognition for the unit’s contribution to Biomedical Research since 2023. In addition, the National Health and Medical Research Council, Govt. of Australia recognized the research unit as “Accelerating Research and Progress in Maternal & Newborn Health Centre for Research Excellence” (ARPAN CRE) since 2023. The Research Unit is the ‘ONLY CENTRE IN INDIA’ with Five Distinguished Recognition by ICMR-DHR (GoI), WHO, NICHD-USA and NHMRC-Australia.
The JNMC Research Unit and its multi-disciplinary research team has been conducting Community and Facility based research activities, completing 52 studies aimed at decreasing maternal and child mortality for past 24 years. The unit has collaborated with 25 International Universities and Research Institutes from USA, UK, Canada, South Africa, Australia, Uganda, Zambia and Argentina and 25 Medical & Research Institutes in India. The unit has received funding support from WHO, NICHD, other NIH agencies, BMGF, CIFF, AAP, Gynuity Health Projects, Thrasher Research Fund, Grand Challenges Canada, DBT-Govt.of India and the UK-MRC.
The Research Unit is well-equipped with research capabilities, Including adequate technical and competent manpower support. The data coordinating center at the KLE Research Unit is equipped with trained data management staff members, RedCap servers, and power backup to facilitate electronic data acquisition, processing, and data archival and data transmission. The central data team at the research unit coordinates data management with the auxiliary data management centers established at each collaborating center. Furthermore, a dedicated pharmacy facilitates the storing and packaging of investigational medicine products for clinical trials. Moreover, state-of-the-art telecommunication and audio-visual training equipment enable fast and effective communication and training capabilities. The multidisciplinary central research team comprising of experienced clinicians from diverse clinical specialties and super-specialties, basic science researchers/scientists, community medicine specialists, epidemiologists, and statisticians coordinate and supervise the proper conduct of clinical trials, and have played a pivotal role in the generation of high-quality research data.
Research unit has prioritized community-based and facility-based research studies in the field of maternal health related to the identification, prevention, and treatment of various maternal adverse health conditions, including Postpartum Hemorrhage (PPH), Hypertensive Disorders of Pregnancy (HDP), Maternal malnutrition, pregnancy-associated anemia, intrapartum associated events, maternal sepsis, high-risk pregnancy care, and maternal mental health disorders. The research unit has expanded their collaborative network of communities and facilities across the country with an intention of having long-term commitments for scaling up interventions if proven successful. A strong Public Private Partnership with the District Health Administration of the Belagavi, Bagalkot, Vijayapura, Davanagere, Dharwad-Hubballi, Gadag, Ballari and Raichur districts of Karnataka and Cuttack and Balasore districts of Odisha, Jaipur district of Rajasthan and has established research collaboration with more than 20 medical colleges and research institutes across the country for implementing community / hospital-based interventions to improve the quality of maternal and infant care, with country wide regional representation.
Furthermore, facility and community-based research studies aimed at the prevention and treatment of various newborn health-related conditions, including perinatal asphyxia, prematurity, neonatal sepsis, neuro-developmental impairment, infant malnutrition, impaired lactation, and lactation support have been the area of priority and expertise for the research unit. Also, high-tech KLES Dr Prabhakar Kore Hospital and Medical Research Centre, a tertiary care advanced reference center, which is a 2,400-bed hospital (with 1,200 designated to providing charitable care) is adequately equipped and capable of conducting high-quality facility-based research in various clinical specialties, including childhood disorders, cardiovascular health, cerebrovascular disorders, advanced diabetes care, and obesity management and prevention. The research unit has developed the state-of-the-art neurodevelopment assessment facilities in Belagavi and other collaborating institutes. The unit is also equipped with trained faculty to conduct the assessments including BSID, ASQ, DASII, etc.
KLE University houses the Dr. Prabhakar Kore Basic Science Research Center, a 18,000-square foot facility established as a center of excellence in basic research and training. The center is dedicated to basic research and educational activities in various fields. At present, it is primarily involved in medical microbiology, molecular biology, pharmaceutical analysis, cell culture, and natural product research. Those involved with the center acquire technical knowledge from experienced and dedicated scientists and research staff.
Expanding its horizons to address the growing need for specialized diagnostic and research capabilities, a state-of-the-art research lab is being established on the 4th floor of the WCHRU, spanning an expansive 3,000 square feet. This upcoming facility is designed to meet the highest standards of accreditation compliance, ensuring its alignment with national and international benchmarks. The lab will host dedicated areas for molecular biology, focusing on advanced diagnostics and research. It will house specialized spaces for performing Nucleic Acid Amplification Tests (NAAT), an essential tool for the detection of pathogens and genetic mutations with unparalleled sensitivity. Additionally, a dedicated section for Liquid-Based Cytology (LBC) will be established to revolutionize cytological testing, particularly in cervical cancer screening. This technique is known for its enhanced sample quality, enabling more accurate and reliable diagnoses. Furthermore, an ELISA (Enzyme-Linked Immunosorbent Assay) testing area will support quantitative and qualitative detection of proteins, hormones, and other biomarkers critical for clinical and research purposes.
The lab is also set to introduce microbiology testing capabilities, further broadening its diagnostic and research spectrum. This addition will support testing for infectious diseases and microbial pathogens, an essential component in the holistic approach to women’s and children’s health. By integrating these advanced technologies, the facility aims to become a cornerstone for precision medicine and translational research. The research lab is envisioned as a Center of Excellence in Cervical Cancer Testing, addressing a significant health burden faced by women in the region and beyond
The JNMC research unit’s excellent research track record with several landmark Community/Facility-based research studies that have been published in high-impact factor international journals is testimony to the same. The results of many such insightful research studies have had a profound impact at national and international levels in shaping public health policies. The critical evidence provided by the ‘Oral Misoprostol Trial’ led to the inclusion of Misoprostol on the ‘World Health Organization’s List of Essential Medicines’ for prevention of postpartum hemorrhage (PPH) and stronger advocacy of Misoprostol for PPH prevention by the ‘United Nation’s 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 26 countries. The research unit led the WHO-CHAMPION Trial demonstrating the effectiveness of Heat Stable Carbetocin in preventing PPH. The results of this trial necessitated the updating of WHO recommendations Uterotonics for Prevention of Postpartum Hemorrhage in December 2018. The Microlife Sphygmomanometer used in India CRADLE trial was one of 30 (among 500) high impact innovations to save lives Reimagining Global Health, Innovation Countdown in 2030 initiative, received the first ever Newton Prize for excellent research and innovation in support of economic development and social welfare. The First Breath Trial evaluating community-based neonatal resuscitation intervention developed by AAP and WHO; Helping Babies Breathe (HBB) curriculum was incorporated into the national neonatal resuscitation training curriculum called “Navajat Shishu Suraksha Karyakram” (NSSK) of the Government of India. The ‘Implementation of the WHO Safe Childbirth Checklist program’ was evaluated as a pilot, pre-post-intervention study in a sub-district level birth centre in Karnataka in 2010 by JNMC. This validation of the WHO Safe Childbirth Check List Program has resulted inclusion as one of the components in “Resource Package for Quality Improvement Cycles in LAQSHYA” by the Ministry of Health & Family Welfare, Government of India in 2018. A revised version of the WHO Partograph – the “WHO Labour Care Guide (LCG)” – has been developed to make it easier for healthcare providers to routinely implement WHO’s latest evidence-based recommendations on intrapartum care. The study was implemented at Belagavi and Balasore. The results and recommendations led to WHO Modified Labour Care Guide in 2020.
‘Maternal Newborn Health Registry’ a prospective system of identification of likely-to-conceive aiding early identification, tracking and enrollment of the pregnant women was later adopted with essential modification by the Government of Karnataka and was implemented across the state as “Reproductive and Child Health Register (Village wise)”.
Funding Agencies
Completed Research Protocols
1. Limiting Adverse Birth Outcomes in Resource -Limited Settings – The LABOR Study” in collaboration with University of North Carolina at Chapel Hill, USA and funding by Bill & Melinda Gates Foundation, USA (January 2020 to October 2022) (# enrolments completed: 4,017) Global Sample Size: 12,000
2. “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 2022) (Data Collection completed for 600 Mothers and 510 Babies)
3. “COVID-19 prevalence during pregnancy and pregnancy outcomes in 8 low and middle-income sites: MNH COVID-19” 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 (August 2020 – June 2022) (# enrolments completed: 3,114) Global Sample Size: 23,656
4. “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 (May 2019 to May 2022) (India enrolments: 156 (77 in planned delivery and 79 in expectant management) and Zambia enrolments: 407 (205 in planned delivery and 202 in expectant management)
5. “Promoting MITS activities to determine cause of death among neonates and stillbirths in tertiary care teaching hospital” in collaboration with RTI International, NC, USA and funded by Bill & Melinda Gates Foundation, USA (May 2019 to March 2022) (# enrolments: 30)
6. “Aspirin Supplementation for Pregnancy Indicated Risk Reduction in Nulliparous (ASPIRIN): Neurodevelopmental Follow-up Trial” in collaboration with Thomas Jefferson University, Philadelphia, PA, USA and funding from Thrasher Research Fund, USA (December 2021 – June 2022)
(# enrolments: 116) (Global Sample Size: 625)
7. “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 – December 2021) (# Mothers enrolled: 2,261; # Stillbirths enrolled: 377 and # Neonatal Deaths enrolled: 329)
8. “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) (# Screened: 9,129 and # Cryotherapy done: 15)
9. “SCOPE – Standardization of COvid in PrEgnancy Standardizing of data collection and protocol for improving the Quality of evidence on clinical characteristics and outcomes of COVID-19 and Pregnancy” with funding from World Health Organization – Country Office for India, New Delhi
(July 2020 – January 2021) (Data collection completed: 938 Covid-19 cases and 1,190 controls)
10. “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. (# enrolments: 579, recruited 20% of global sample size 2,852)
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. (# enrolments: 778 only in India)
Sponsored by World Health Organization, Geneva from June 2017 to September 2020
11. “Breastfeeding Education Support Tool for Baby (BEST4Baby)” funded by Fogarty International Center, National Institutes of Health, USA (October 2017 – September 2020) (# enrolments: 240 and 25 peer-counsellors trained)
12. “Sit Down and Play” in collaboration with University of Illinois at Chicago, USA and funded by Eunice Kennedy Shriver National Institute of Child Health and Human Development, USA (November 2019 – December 2020) (# enrolments: 47 children)
13. “Evaluating the WHO Labour Care Guide in clinical settings” Sponsored by World Health Organization, Geneva, Switzerland. (September 2019 to December 2019) (# Health Care Providers Trained: 26; # women enrolled: 201, recruited 16% of global sample size 1,226)
14. “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)
(# enrolments: 1,415, recruited 20% of global sample size of 7,151)
15. “Vital signs alert Evaluating Shock index in Pregnancy Anaemia” project in collaboration with King’s College London, UK and funded by Newton Prize, Department of Business, Energy and Individual Strategy (July 2018 – July 2019)
16. “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) (# enrolments: 1,824, recruited 24% of global sample size 7,376)
17. “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)
(# enrolments: 2,750, recruited 23% of global sample size of 11,976)
18. “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) (# enrolments: 14,783, recruited 21% of global sample size 69,330)
19. “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) (# enrolments: 23,853, recruited 4% of global sample size 5,36,233)
20. “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)
(# enrolments: 7,098, recruited 24% of global sample size 29,645)
21. “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) (# Screened: 6,476; # enrolments: 1,727)
22. “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) (November 2011-October 2013) (# Master Trainers Trained: 38 and # Birth Attendants trained: 460)
23. “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) (# enrolments: 18,175, recruited 18% of global sample size 98,137)
24. “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)
(# enrolments: Primary Prevention: 1,075 and Secondary Prevention: 1,957)
25. “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) (# enrolments: 44 children)
26. “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) (# enrolments: 685, recruited 19% global sample size 3,593)
27. “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) Facility Training: 497; HBLSS Training 698; Community Training or meeting: 2059; Providers Trained: 295; Total Facilities: 69; Core Groups: 667; Total Meetings: 33,802)
28. “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) (# enrolments: 159, recruited 39% global sample size 407)
29. “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) We observed health workers attending to 499 birth events during the baseline period (July–September, 2010) and 795 birth events after introduction of the checklist program (September– December, 2010)
30. “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) (# enrolments: 30 children)
31. “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) (599 Birth Attendants trained)
32. “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) (# enrolments: 2,165, recruited 9% of global sample size 24,390)
33. “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) (# enrolments: 300)
34. “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) (# enrolments: 750, recruited 33% global sample size 2,434)
35. 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) (ENC Training for 1,181 Birth Attendants including 753 TBAs)
36. “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)
(# enrolments: 736, recruited 9% global sample size 7,961)
37. “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) (# enrolments: 1,620)
Ongoing Research Protocols
1. Validation of a Survey Instrument for Screening of Pre-Pregnant Women The PREPSA SCALE in collaboration with Thomas Jefferson University and funding from Global Network for Women’s and Children’s Health Research of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, USA (December 2022 – December 2023)
2. Prevention of Iron Deficiency Anemia Post-delivery (PRIORITY Trial) A Randomized Controlled Trial of the Global Network for Women’s and Children’s Health Research” in collaboration with Thomas Jefferson University, Philadelphia, PA, USA and funding by Global Network for Women’s and Children’s Health Research of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, USA, Bill & Melinda Gates Foundation, USA and Foundation for the National Institutes of Health, USA (November 2022 – November 2025)
3. “Augmented Infant Resuscitator (AIR)” in collaboration with Mbarara University of Science and Technology, Uganda and Massachusetts General Hospital, Harvard University, Boston with funding from Grand Challenges Canada (November 2022 – November 2024)
4. “RAPIDIRON Imaging Sub-study” in collaboration with Thomas Jefferson University, Philadelphia, PA, USA and funding by Global Network for Women’s and Children’s Health Research of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, USA (February 2022 -February 2026)
5. “RAPIDIRON-Kids Study” in collaboration with Thomas Jefferson University, Philadelphia, PA, USA and funding by Children’s Investment Fund Foundation (CIFF), UK (February 2022 -February 2026)
6. Single oral dose of azithromycin 2 gm to prevent maternal peripartum infection and newborn sepsis in laboring women (A-PLUS Trial): Repurposing azithromycin as a neuro-protector; a neurodevelopmental follow-up secondary study in collaboration with Thomas Jefferson University, Philadelphia, PA, USA and University of Alabama, Birmingham, USA with funding from Thrasher Research Fund, USA (November 2022-March 2023)
7. “A Cluster Randomized Clinical Trial of Umbilical Cord Milking versus Early Cord Clamping on Short and Long-term Outcomes in Neonates Who are Non-Vigorous at Birth” in collaboration with Nemours Children’s Hospital and Thomas Jefferson University with funding from Eunice Kennedy Shriver National Institute of Child Health and Human Development, USA (September 2021-September 2025) Recruitment Started from October 19, 2022
8. “A66014: Simplified Treatment for Eclampsia Prevention using Magnesium sulfate: A phase III, randomized, open label, active controlled, multicountry, multicentre, non-inferiority trial of simplified magnesium sulfate regimen for eclampsia prophylaxis (The STEP-Mag Trial)” with funding from World Health Organization, Geneva, Switzerland (May 2021 – May 2024) Recruitment started from November 25, 2022
9. “WHO ACTION-III TRIAL: A multi-country, multi-centre, three-arm, parallel group, double-blind, placebocontrolled, randomized trial of two doses of antenatal corticosteroids for women with a high probability of birth in the late preterm period in hospitals in low-resource countries to improve newborn outcomes” sponsored by World Health Organization, Geneva, Switzerland (November 2020 – April 2024) (Sample Size: Superiority comparison 1,929 and Non-inferiority Comparison: 2,184) (# enrolment till December 9, 2022: 148)
10. “Implementing the WHO Labour Care Guide to reduce the use of Caesarean section in four hospitals in India: a pragmatic, stepped wedge, cluster randomized pilot trial” in collaboration with Burnet Institute, Australia; Institute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires – Argentina; and the World Health Organization with funding from Bill & Melinda Gates Foundation, USA (November 2020 – October 2023) (# enrolments as on July 2022: 27,400) (Sample Size: 23,000)
11. “Reducing Anemia in Pregnancy in India: The RAPIDIRON Trial” in collaboration with Thomas Jefferson University, Philadelphia, PA, USA and funding by Children’s Investment Fund Foundation (CIFF), UK (September 2020 to August 2023) (# enrolments as on December 2, 2022: 2,841) Sample Size: 4,320
12. “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 February 2023) (# enrolments completed: 5,635) Global Sample Size: 29,278
13. “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 – May 2023) (# enrolments till December 9, 2022: 1,87,683, All GN Sites total enrolments 8,21,083)
Upcoming Research Protocols
- 1. “Safety and Efficacy of Heat Stable Carbetocin vs Oxytocin for treatment of Postpartum Hemorrhage” with funding from World Health Organization, Geneva, Switzerland
- 2. “XSTAT Device for PPH Treatment” in collaboration with Concept Foundation, Geneva, Switzerland and Oregon Health & Science University with funding from Obstetrx, USA
- 3. “AIM-Gender” in collaboration with Concept Foundation, Geneva, Switzerland with funding from Merck and Co., Inc (Merck) via the MSD for Mothers initiative.