JNMC Womens & Children’s Health Research Unit

JNMC Women’s and Children’s Health Research Unit 

The Women’s and Children’s Health Research Unit (WCHRU) of Jawaharlal Nehru Medical College of KLE Academy of Higher Education and Research (Deemed-to-be-University) (KAHER)’s has been conducting Community/Facility-based research aimed at reducing maternal and newborn mortality and morbidity since 2001. Over the past twenty-three years, JNMC’s multi-disciplinary research team in collaboration with international multi-disciplinary team of clinicians, basic medical scientists, nutritionists, public health experts, information technology specialists, and other research staff with essential expertise and skills, including those trained for infant and early childhood growth and neurodevelopment assessment.

The WCHRU has participated in 52 research studies (with the majority being multi-country and multicentre), with 38 completed over the last 22 years and published more than 230 research publications out of these trials in collaboration with 51 universities and research institutions from the USA, UK, Canada, Zambia, South Africa, Australia, and various institutes across India with funding support of Rs. 175 crores from 17 sponsors including: WHO, NIH, BMGF, Thrasher Research Fund, UK-Medical Research Council, and Department of Biotechnology, Government of India.

The WCHRU has been funded by National Institute of Child Health and Human Development (NICHD) Global Network since the inception of the network in 2001. It has been refunded recently for the next seven-year cycle of the Global Network through 2030.

The WCHRU is designated as a “WHO Collaborating Center for Research in Maternal and Perinatal Health” for a period of four years w.e.f. September 16, 2019 and it is currently in the process of getting re-designated for a further period of four years till 2027.

The WCHRU always assures adequate staffing so that multiple studies can be carried out concurrently during the specified time frame, and trained research staff can be sustained and expanded as necessary. The unit’s research priorities include: Postpartum Hemorrhage, Hypertensive Disorders of Pregnancy, Maternal Nutrition, Birth Asphyxia, Preterm Birth, Infant Neurodevelopment, Health System Strengthening and Community-based Maternal Newborn Health Registry. The results of these insightful research studies have had a profound impact at national and international levels in shaping public health policies.

The WCHRU has established strategic relationships with 20 Indian academic institutions from Karnataka, Maharashtra, Rajasthan, Uttar Pradesh, Chandigarh and Odisha to develop a collaborative network; which provides access to secondary and tertiary health facilities for implementation of research protocols.

The WCHRU has a well-equipped central office on the KAHER campus with facilities to securely archive study data, a pharmacy for storing and packaging clinical trial medications in a controlled environment, access to training facilities and audio-visual equipment, state-of-the-art network, computers, printers and sophisticated telecommunication capabilities that enable fast and dependable communication with collaborating partners. The WCHRU at Belagavi has a separate temperature-controlled room with power backup housing a 70 Mbps lease line with 128 direct IP setup, two mirror-configured REDCap servers, additional dedicated servers for data storage and transmission, electronic data capture, data hosting services, and a data archival room. Twenty-five auxiliary data centers established by the WCHRU and trained data management staff are available at all the other collaborating institutions of India.

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