“As resources will always be limited, these should be used in such a way as to equitably provide those health care forms which have been shown to be effective through appropriately designed assessments.” — Archie Cochrane
Global Network Research in India: The Christiana Care Health Systems (CCHS) - Jawaharlal Nehru Medical College (JNMC) Collaboration
In 2001, Dr. Richard Derman was selected, along with Jawaharlal Nehru Medical College (JNMC) of KLE University in Belgaum (Karnataka, India), for membership in the Global Network for Women’s and Children’s Health Research. Participation in this Network conveyed the benefit of multi-year funding for development of a Research Unit and support of research initiatives under a cooperative agreement with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Dr. Derman, the Endowed Chair of the Department of Obstetrics and Gynecology and the Director of the Center for Women's, Infants’ and Children's Health Research at Christiana Care Health Systems (CCHS), serves as the Principal Investigator of the CCHS-JNMC Research Unit which represents an international, multi-disciplinary research team of clinicians, basic scientists, public health experts, and information technology specialists. Dr. Bhalachandra Kodkany of JNMC serves as the Unit’s Senior Foreign Investigator, and Dr. Shivaprasad S. Goudar is the Research Coordinator and Co-Investigator.
The Global Network was established to advance research capacity in resource poor settings and to implement clinical research to identify feasible, cost-effective, sustainable interventions to address public health challenges and to improve health outcomes of women and children. A primary Global Network objective is to accelerate achievement of Millennium Development Goal 4 (to reduce child mortality) and Goal 5 (to improve maternal health) in low and lower-middle income countries.
Accomplishments of the CCHS-JNMC Global Network Research Unit
Implementation in the Belgaum District of Karnataka State, India of a seminal, community-based trial of oral misoprostol for postpartum hemorrhage prevention and the publication of findings in The Lancet and other peer-reviewed journals which provided critical evidence for:
- inclusion of misoprostol on the World Health Organization’s List of Essential Medicines for prevention of postpartum hemorrhage (PPH) when oxytocin is unavailable,
- stronger advocacy of misoprostol for PPH prevention by the UN Commission on Life-Saving Commodities for Maternal Health,
- adoption of the Government of India policy which recommends misoprostol for community level PPH prevention,
- expansion of the registration and use of misoprostol for PPH prevention, and
- widespread use of the BRASSS-V calibrated drape, which was developed and validated as a means to elevate the reliability and precision of measurement of postpartum blood loss.
A contribution of more than 33% of the total records (316,425 delivery outcome records and 309,517 records for neonatal outcomes through 42 days post-delivery, April 2013) entered into the 7-site GN Maternal Newborn Health Registry implemented in 2008 to monitor the impact of Global Network interventions; the highest follow-up rates and a percentage of records obtained to records expected of 99.9%.
Participation in the WHO evaluation of controlled cord traction to reduce postpartum blood loss and co-authorship of the publication presenting study findings.
Provision of mentoring and training in association with the Global Network Scholars Program and design and implementation of studies that included:
- research on the contribution of consanguinity to prematurity, low birthweight and fetal loss,
- a randomized controlled trial of the effects of oral clindamycin on preterm delivery, stillbirth and neonatal outcome, and
- the most definitive trial of the effectiveness of low dose sublingual misoprostol for postpartum hemorrhage prevention.
Other research initiatives completed since the launch of the Research Unit:
- assessments of tobacco use, smoking behaviors and indoor pollution,
- First Breath, a trial launched at 7 GN sites located in Asia, Africa and Latin America on World Health Day, 2005 to assess the effectiveness of the American Academy of Pediatrics (AAP) Neonatal Resuscitation Program implemented in conjunction with the WHO’s Essential Newborn Care Course on stillbirths and early neonatal mortality,
- the Helping Babies Breathe (HBB) project of the American Academy of Pediatrics which involved assistance from JNMC in the development of a new neonatal resuscitation curriculum for use in low resource countries and JNMC’s training of 816 birth attendants in 86 training sessions using the new HBB module,
- the Global Network Study to Assess Gestational Age by Fundal Height (TAPE Study - Phase I and Phase II) to assess and validate the accuracy of estimating gestational age with the use of a tape measure developed to estimate the gestational age of a fetus when ultrasound is unavailable,
- the Emergency Obstetric and Newborn Care (EmONC) study, which assessed the effectiveness of a multifaceted intervention package as a means for reducing stillbirths and neonatal mortality,
- the Community Birth Attendant Survey to assess maternal and newborn health services provided by community birth attendants,
- the Brain Research to Ameliorate Impaired Neurodevelopment: Home Based Intervention Trial (BRAIN HIT), which developed a program for home-based intervention, evaluated the effects on neurodevelopmental outcomes, and generated recommendations for implementing strategies to reduce neurodevelopmental disabilities in at-risk young children in low-resource countries and settings,
- a collaboration between JNMC, WHO and the Harvard School of Public Health which demonstrated the benefits of using the WHO Safe Childbirth Checklist and resulted in the Ministry of Health, Karnataka State recommending adoption of the checklist.
Participation in HBB activities sponsored by the American Academy of Pediatrics and the HBB Global Development Alliance which resulted in the following:
- JNMC faculty participation in the design of Basic Newborn Care and Resuscitation Program: Navajat Shishu Suraksha Karyakram (NSSK), a program recommended by the Government of India, and
- selection of JNMC as one of three GN sites to receive NICHD and private donor funds to implement Evaluation of HELPING BABIES BREATHE in Belgaum, Kenya and Nagpur: Does Implementation of HELPING BABIES BREATHE Save Lives?
Evaluation of HELPING BABIES BREATHE is scheduled for wrap-up in fall of 2013; study data will be analyzed to assess the impact of training thousands of birth attendants in the HBB curriculum and establishing disciplined programs in facilities with HBB-trained birth attendants to ensure practice, retention and use of the HBB skills and procedures when needed to save babies lives.
In fall of 2013, the CCHS-JNMC Research Unit, along with other Global Network researchers, will conclude the Antenatal Corticosteroids Trial (ACT), a multi-site study implemented to measure the impact of increasing the availability of antenatal corticosteroids in community-based settings of selected intervention clusters, improving recognition of women at risk for delivering pre-term infants, and removing barriers to administration of a course of corticosteroids (by training providers authorized to use antenatal corticosteroids and improving referral and transfer arrangements).
Interventions used in most studies to-date have demonstrated positive impact on maternal and neonatal outcomes; and the studies to be completed in 2013 should have comparable impact. Global Network participation has strengthened the research infrastructure at JNMC and at the sites of other Global Network partners located in low and lower-middle income countries. Further, many partners are leveraging Network membership to gain support from foundations and other organizations that support global health research. The probability is therefore high that Global Network Research Units and international collaboration in women’s and children’s health research will be sustained well into the future, even after the third cycle of the Global Network ends in 2018.
Publications Attributable to the CCHS-JNMC Collaboration
- Bellad MB, Goudar SS. Misoprostol: theory and practice. In: B-Lynch C, Keith LG, Lalonde AB, and Karoshi M, Editors. A Textbook of Postpartum Hemorrhage. A Comprehensive Guide to Evaluation, Management and Surgical Intervention. Duncow, Kirkmahoe, Dumfriesshire: Sapiens Publishing; p. 114-126; 2006.
- Bellad MB, Laxmi BV, Goudar SS, Kumar A. Standardized visual estimation of blood loss during vaginal delivery with its correlation hematocrit changes – a descriptive study. Journal of South Asian Federation of Obstetrics and Gynecology; 1(1): 29-34; 2009 Jan-Apr.
- Bellad MB, Tara D, Ganachari MS, Mallapur MD, Goudar SS, Kodkany BS, Sloan NL, Derman R. Prevention of postpartum haemorrhage with sublingual misoprostol or oxytocin: a double blind randomised controlled trial. Br J Obstet Gynecol. 2012;119(8):975-86. doi: 10.1111/j.1471-0528.2012.03341.x
- Carlo WA, Goudar SS, Parida S, Jehan I, Tshefu A, Chomba E, Athabe F, Graces A, Derman RJ, Panigrahi P, Goldenberg R, Bose C, Buekens P, Krebs N, McClure E, Chakraborty H, Harris H, Wright L: The Global Network’s First Breath Study Group. Newborn care training and perinatal mortality in communities. New England Journal of Medicine; 2010 Feb 17.
- Carlo WA, Goudar SS, Pasha O, Chomba E, McClure EM, Biasini FJ, Wallander JL, Thorsten V, Chakraborty H, Wright LL; Brain Research to Ameliorate Impaired Neurodevelopment- Home Based Intervention Trial Committee and the National Institute of Child Health and Human Development Global Network for Women’s and Children’s Health Research. Neurodevelopmental outcomes in infants requiring resuscitation in developing countries. J Pediatr. 2012 May;160(5):781-5.e1. Epub 2011 Nov 17.
- Carlo WA, Goudar SS, Pasha O, Chomba E, Wallander JL, Biasini FJ, McClure EM, Thorsten V, Chakraborty H, Wallace D, Shearer DL, Wright LL; Brain Research to Ameliorate Impaired Neurodevelopment-Home-Based Intervention Trial Committee and the National Institute of Child Health and Human Development Global Network for Women's and Children's Health Research Investigators. Randomized trial of early developmental intervention on outcomes in children after birth asphyxia in developing countries. J Pediatr. 2012 Nov 16. doi:pii: S0022-3476(12)01144-4.
- Chakraborty H, Bartz J, Goudar SS. Estimating the effect of unplanned interventions in the randomized misoprostol trial: A mixed model analysis. Int J Gynaecol Obstet; 94 (Supplement 2), page S136; 2006.
- Derman R. The role of misoprostol for prevention of postpartum hemorrhage. Int J Gynaecol Obstet; 94 Suppl 2: S131-2; 2006.
- Derman RJ, Kodkany BS, Goudar SS, Geller SE, Naik VA, Bellad MB, et al. Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial. Lancet; 368: 1248–53; 2006.
- Geller SE, Adams MG, Kelly PJ, Kodkany BS, Derman RJ. Postpartum hemorrhage in resource-poor settings. Int J Gynaecol Obstet; 92(3): 202-11; 2006 Mar. Epub. Review.PMID:16427056; 2006 Jan 19.
- Geller SE, Goudar SS, Adams MG, Naik VA, Patel A, Bellad MB, Patted SS, Edlavitch SA, Moss N, Kodkany BS, Derman RJ. Factors associated with postpartum hemorrhage in low-risk women delivering in rural India. Int J Gynaecol Obstet; 101(1): 94-9; 2008 Apr; Epub 2008 Mar 4.
- Geller SE, Naik V, Patel A, Goudar SS, Edlavitch SA, Kodkany BS, Derman RJ. Ethical issues in conducting international research studies. Int J Gynaecol Obstet; 94 Suppl 2: S129-30; 2006.
- Geller SE, Patel A, Naik VA, Goudar SS, Edlavitch SA, Kodkany BS, Derman RJ. Conducting international collaborative research in developing nations. Int J Gynecol Obstet; 87(3): 267-71; 2004.
- Goudar SS, Brinkley MF, Forvendel DG, Singh AP, Revankar AP, Kodkany BS, Derman RJ. Data management system for community-based randomized controlled trial in India. Proceedings of the Indian Conference on Medical Informatics and Telemedicine, IIT Kharagpur; p 71-75; 2005 Feb 27-Mar 1, 2005.
- Goudar SS, Chakraborty H, Edlavitch SA, Naik VA, Bellad MB, Patted SS, Patel A, Moore J, McClure EM, Hartwell T, Moss N, Derman RJ, Kodkany BS, Geller SE. Variation in the postpartum hemorrhage rate in a clinical trial of oral misoprostol. J Matern Fetal Neonatal Med; 21(8): 559-64; 2008 Aug.
- Goudar SS, Dhaded SM, McClure EM, Derman RJ, Wright LL, Bellad RM, Kodkany BS, Moore JM, Carlo WA. ENC training reduces perinatal mortality in Karnataka, India. J Matern Fetal Neonatal Med. 2012 Jun;25(6):568-574. Epub 2011 Jul 27.
- Goudar SS, Somannavar MS, Clark R, Lockyer JM, Revankar AP, Fidler HM, Sloan NL, Niermeyer S, Keenan WJ, Singhal N.. Stillbirth and newborn mortality in India after Helping Babies Breathe® training. Pediatrics 2013 Feb; 131(2);e44-52, doi: 10.1542/peds.2012-2112. Epub 2013 Jan 21.
- Gülmezoglu AM, Lumbiganon P, Landoulsi S, Widmer M, Abdel-Aleem H, Festin M, Carroli G, Qureshi Z, Souza JP, Bergel E, Piaggio G, Goudar SS, Yeh J, Armbruster D, Singata M, Pelaez-Crisologo C, Althabe F, Sekweyama P, Hofmeyr J, Stanton ME, Derman R, Elbourne D. Active management of the third stage of labour with and without controlled cord traction: a randomised, controlled, non-inferiority trial. Lancet. 2012 May 5;379(9827):1721-7. Epub 2012 Mar 6.
- Kodkany BS, Derman RJ. Pitfalls in assessing blood loss and decision to transfer. In: B-Lynch C, Keith LG, Lalonde AB, and Karoshi M, Editors. A Textbook of Postpartum Hemorrhage. A Comprehensive Guide to Evaluation, Management and Surgical Intervention. Duncow, Kirkmahoe, Dumfriesshire: Sapiens Publishing; p. 35-44; 2006.
- Kodkany BS, Derman RJ, Goudar SS, Geller SE, Edlavitch SA, Naik VA, Patel A, Bellad MB, Patted SS. Initiating a novel therapy in preventing postpartum hemorrhage in rural India: a joint collaboration between the United States and India. International Journal of Fertility and Women’s Medicine; 49(2): 91-6; 2004.
- Kodkany BS, Derman RJ, Sloan NL. Pitfalls in assessing blood loss and decision to transfer. In: Arulkumaran S, Karoshi M, Keith LG, Lalondé AB, B-Lynch C, Editors. A Comprehensive Textbook of Postpartum Hemorrhage: An Essential Clinical Reference for Effective Management, 2nd Edition. Sapiens Publishing, Dumfriesshire. 2012.
- Kodkany BS, Goudar SS, Derman RJ. The efficacy of oral misoprostol in preventing postpartum hemorrhage in a community setting: A randomized double-blind placebo-controlled trial. Int J Gynaecol Obstet; 94 Suppl 2: S141-2; 2006.
- Kodkany BS. Evidence-based interventions to prevent postpartum hemorrhage: translating research into practice. Int J Gynaecol Obstet; 94 Suppl 2: S114-5; 2006.
- Patel A, Goudar SS, Geller SE, Kodkany BS, Edlavitch SA, Wagh K, et al. Drape estimation vs. visual assessment for estimating postpartum hemorrhage. Int J Gynaecol Obstet; 93: 220–4; 2006.
- Patted SS, Goudar SS, Naik VA, Edlavitch SA, Patel A, Chakraborty H, Kodkany B, Derman R, Geller SE. Side Effects of oral misoprostol for prevention of postpartum hemorrhage on the mother and newborn in a community-based randomized controlled trial in rural India. J Matern Fetal Neonatal Med. 22(1): 24-8, 2009 Jan.