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

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 of Jawaharlal Nehru Medical College of KLE Academy of Higher Education and Research (KAHER) (Deemed-to-be-University) has been conducting Community-Oriented Research activities aimed at decreasing maternal and child mortality since 2001. Over the past twenty years, JNMC’s multi-disciplinary research team has conducted a number of community / hospital based research projects in collaboration with 27 international Universities and Research Institutes from USA, UK, Canada, South Africa, Australia, Uganda, Zambia and Argentina and 24 Medical Institutes, Universities and Research Institutes in India with funding support from World Health Organization, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Global Network for Women’s and Children’s Health Research, other NIH agencies, Bill & Melinda Gates Foundation (BMGF). The Children’s Investment Fund Foundation (CIFF), American Academy of Pediatrics (AAP), Gynuity Health Projects, Thrasher Research Fund, Grand Challenges Canada, Department of Biotechnology (DBT) Govt. of India and the UK Medical Research Council (MRC). The results of these insightful research studies have had a profound impact at national and international levels in shaping public health policies. Till now Research Unit conducted more than 40 trials sponsored by various agencies and published more than 190 research articles out of these trials.

The Research Unit has been funded by National Institute of Child Health and Human Development (NICHD) Global Network since the inception of the network in 2001. Based on its commendable performance during the first cycle, the ‘Research Unit’ gained recognition as one of the six among the ten sites to be re-funded for a third cycle of five years until 2018 and this has been further continued in the Fourth Consecutive Cycle of funding until 2023.

The Women’s and Children’s Health Research Unit, Jawaharlal Nehru Medical College, KLE Academy of Higher Education and Research, Belagavi is designated as a “WHO Collaborating Center for Research in Maternal and Perinatal Health” for a period of four years effective from September 16, 2019.

JNMC Women’s and Children’s Health Research Unit has received a unique distinction as ICMR Center for Clinical Trials (ICCT) w.e.f December 28, 2021. This is a part of the “Indian Clinical Trial & Education Network (INTENT)” launched by Indian Council of Medical Research (ICMR) and Department of Health Research (DHR) for a period of five years.

The Research Unit has built 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 for implementing community / hospital-based interventions. Over the years, in Karnataka itself, the Research Unit has served a population of over 20 lakhs people residing in over 800 villages spread over twenty-three talukas of Belagavi, Bagalkot, Vijayapura, Davanagere, Dharwad-Hubballi, Gadag, Ballari and Raichur districts. This population is served by 116 Primary Health Centers, 15 Taluka Hospitals, 4 District Hospitals, 131 Private Hospitals and Clinics and 20 Academic Tertiary Care Centers. 1,995 Health Care Providers and health workers in these facilities have been trained for ethical conduct of research and data collection. It may be noted that Mothers and Newborns in these areas have been provided treatment free of cost as and when needed.

Research Priorities

  • Surveillance System
    • Maternal Newborn Health Registry (MNHR)
  • Maternal Health
    • Postpartum Hemorrhage (PPH)
    • Hypertensive Disorders of Pregnancy (HDP)
    • Maternal Nutrition
    • Pregnancy Anaemia
    • Tobacco use during pregnancy
    • Optimizing Intrapartum care during labour
    • Maternal Sepsis
    • Cervical Cancer
    • Prediction of High-risk Pregnancy
    • Maternal Mental Health
  • Newborn Health
    • Birth Asphyxia
    • Preterm Birth
    • Infant Neurodevelopment
    • Breastfeeding Support
    • Infant Nutrition
    • Newborn Sepsis
    • Understanding adverse outcomes of pregnancy
  • Health System Strengthening
    • Emergency Obstetric and Neonatal Care (EmONC)
    • Safe Childbirth Checklist
  • Impact of COVID-19 on Maternal and Neonatal Health
    • Clinical Outcomes of COVID-19 in Pregnancy and Perinatal Health

The Impact

The following is a brief summary of the results of research studies that have had a profound impact at national and international levels in shaping public health policies:

Maternal Health Interventions:

Blood Loss during delivery (Postpartum Hemorrhage)

  • Study Title: “Randomized controlled Trial of Oral Misoprostol for prevention of Postpartum Haemorrhage in women delivering at homes or sub-centres of four Primary Health Centre Areas of Belagavi District”. Misoprostol Tablet is approved by the Government of India for community level prevention of blood loss after delivery (postpartum haemorrhage). This study provided the precious evidence for the inclusion of Misoprostol on the World Health Organization’s List of Essential Medicines and stronger advocacy of Misoprostol for prevention of blood loss after delivery by the United Nation’s Commission on Life-saving commodities for maternal It has also prompted expansion of the registration and use of Misoprostol for prevention of postpartum bleeding, by the Ministries of Health of 26 countries.
  • The BRASSS-V drape, developed with input from JNMC Research Unit investigators, being more accurate than visual estimation of blood loss has particular utility for prompt detection of blood loss during delivery and aids reduction of maternal morbidity and mortality in low resource settings. BRASSS-V drape has been added in the list of Labour room equipment and accessories of ‘Maternal and Newborn Health Tool Kit’ by the Ministry of Health& Family Welfare, Government of India.
  • JNMC Research Unit’s participation in the WHO sponsored clinical trial “A phase III, randomized, double- blind, active, controlled, multinational, multi-center, 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” was indeed an exciting and fulfilling journey from conception of the research (March 2013) through implementation of the trial (May 2016 to January 2018), publication of the results in New England Journal of Medicine (June 2018), updating of the WHO recommendations for the use of uterotonics for prevention of PPH (December 2018), inclusion in the WHO List of Essential List of Medicines (March 2019) to regulatory approval for manufacturing and marketing by Central Drugs Standard Control Organization (Drugs Controller General of India) (September 2020). It is a matter of pride that global release of RTS Carbetocin for public use at a public sector pricing (INR 93 inclusive of GST) on par with standard Oxytocin, was organised by JNMC Women’s and Children’s Health Research Unit in KLE Centenary Convention Center, Belagavi on 23rd July 2021. The first dose of this injection was given in KLES Dr Prabhakar Kore Charitable Hospital on the same day. Carbetocin RTS is also included in UNFPA Product Catalogue of Quality Assured Products related to Reproductive Health (April 24, 2021) and FIGO-ICM recommendation for the use of uterotonics for the prevention of Postpartum Haemorrhage (June 2021).

Hypertensive (Blood Pressure) Disorders of Pregnancy

  • Microlife CRADLE, a semi-automated device for detection of hypertension was tested in rural Africa and within India by the JNMC and King’s College, London collaborative research team to further develop the device as an accurate and low-cost means to improve antenatal detection of high blood pressure (pre-eclampsia) as well as hypotension associated with blood loss after delivery and infection. The trial was co-funded by the United Kingdom Medical Research Council and the Government of India, Department of Biotechnology. Notably, the India CRADLE trial received the first ever Newton Prize for excellent research and innovation in support of economic development and social welfare in Newton Fund partner countries. This device was one of 30 (among 500) high impact innovations to save lives Reimagining Global Health, Innovation Countdown 2030 initiative.

Newborn Health Interventions:

Birth Asphyxia

  • The JNMC Research Unit was one of the five global sites selected by AAP for field testing the Helping Babies Breathe (HBB) curriculum. “Field Implementation of Helping Babies Breathe” project trained over 1,200 birth attendants working in 25 public sector (District Hospital, Belagavi, 7 Taluka hospitals, 2 community health centres and 15 primary health centres) and 8 private sector hospitals of Belagavi district for demonstrated reviving newborn babies who do not breathe immediately after birth (resuscitation). Subsequently, HBB was incorporated into the neonatal resuscitation training curriculum of the Basic Newborn Care and Resuscitation program called “Navajat Shishu Suraksha Karyakram” (NSSK) of the Government of India.

Antenatal Corticosteroids for Preterm birth

  • JNMC Research Unit participated in the Global Network study “Antenatal Corticosteroid Trial”. The results of the trial led to updating of WHO recommendations on preterm birth in 2015 and a new WHO research initiative to assess the efficacy of ACS in reducing mortality in early and late preterm births. Subsequently, JNMC Research Unit participated in the ‘The WHO Antenatal Corticosteroids for Improving Outcomes in Preterm Newborns (WHO-ACTION) trials’ and the primary paper was published in NEJM in Dec, 2020.

Health Systems Interventions:

  • ‘Implementation of the WHO Safe Childbirth Checklist program’, a novel childbirth safety program for hospital births incorporating a 29-item checklist containing essential practices that target the major causes of childbirth-related deaths, was evaluated as a pilot, pre-post-intervention study in a sub-district level birth centre in Karnataka, India between July and December 2010 by JNMC Research Unit with a Collaborative effort with the World Health Organization and Harvard School of Public Health. The study demonstrated a significant improvement in the delivery of 28 out of 29 essential safety practices by health workers. This validation of the WHO Safe Childbirth Check List Program has resulted inclusion as one of the component in ‘Maternal and Newborn Health Tool Kit’ by the Ministry of Health& Family Welfare, Government of India. Using this WHO Safe Childbirth Checklist, as a quality improvement tool, trial was conducted in 60 pairs of facilities across 24 districts of Uttar Pradesh to test the effect of ‘Better Birth program’. JNMC Research Unit investigators provided the technical consultation for the implementation of this study.

Subsequently JNMC Research Unit’s participation in “Evaluating the WHO Labour Care Guide in clinical settings” pilot testing has led to launch of the WHO Labour Care Guide and its User’s Manual by WHO in December 2020.

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: sgoudar@jnmc.edu
Tel (Work): +91 831 244 4194
Fax: +91 831 247 2891
Mobile: +91 94481 26371

 

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.