The first research project to be launched by the research unit was a community-based “Randomized controlled Trial of Oral Misoprostol for prevention of Postpartum Hemorrhage in women delivering at homes or sub-centers of four Primary Health Center Areas of Belgaum District”. The purpose of the initial research study was to test the use of Misoprostol as an oral agent to reduce the incidence of acute postpartum hemorrhage and associated morbidity and mortality in women delivering in designated villages within Belgaum district. This project serves as a model applicable to rural settings throughout India, and possibly has implication for improving delivery practices in other developing countries. The Belgaum site was the first GN site to initiate data collection for the primary trial in September 2002. The site is the first to complete data collection for the primary trial in December 2005. The primary publication arising from this trial was published in the October 7, 2006 issue of ‘The Lancet’.
‘Auxiliary Nurse Midwife obtaining Informed Consent’
The research unit organized an International Congress – Evidence Based Interventions for Preventing Postpartum Hemorrhage – at Goa, India in July 2006 to disseminate the results of the trial. The congress attracted participation of all the major national and international health research and policy making agencies and facilitated the development of recommendations for the management of postpartum hemorrhage during births at homes or basic health care facilities. The positive results of the trial provided the final clinching evidence to World Health Organization for the inclusion of oral Misoprostol for prevention of postpartum hemorrhage. India is one of the first countries to endorse the use of this drug for this indication. The Ministry of Health, Govt. of India also responded favorably by authorizing its use by Auxiliary Nurse Midwives.
‘Inauguration of International Congress on Postpartum Hemorrhage at Goa’
Following the successful implementation of the Misoprostol trial, JNMC was identified by World Health Organization and the Ministry of Health, Govt. of India as nodal center to develop modules for training Medical Officers and Auxiliary Nurse Midwives as well as train faculty of medical colleges in Karnataka in “Skilled Birth Attendance”. The trained faculty in turn has trained the Medical Officers working at 24 x 7 Primary Health Centers within their district. JNMC was entrusted with the responsibility of training Medical Officers of Belgaum District. The project was completed in December 2007.
The ‘Research Unit’ developed a unique under-buttock blood collection drape with a calibrated receptacle for measuring postpartum blood loss for the Misoprostol trial. The drape as a measurement tool was validated with a “Randomized-Controlled Trial to Compare BRASSS-V Drape Measurement and Visual Estimate of Postpartum Blood Loss”. This project was done to compare the BRASSS-V Calibrated Blood Collection Drape to the traditional visual estimation for blood loss. The project was implemented during May 2003 – April 2004. This study was performed on 123 women presenting for delivery at the District Hospital, Belgaum, India where subjects were randomized to visual or drape estimation of blood loss. A sub-sample of ten drape estimate of blood loss was compared to photospectrometry. The visual estimate of blood loss was 33% less than with the BRASSS-V estimate. The BRASSS-V drape is more accurate than visual estimation of blood loss and may have particular utility in the developing world for prompt detection of PPH and may reduce maternal morbidity and mortality in low resource settings. The drape has been used since then in over 20 countries around the world for measuring blood loss in over 200,000 women. The drape has increasingly been acknowledged by the international research community as a valid tool for measurement of postpartum blood loss.
The research unit subsequently participated in a multi-site “Survey of Tobacco Use Among Pregnant Women”. The overall aim of this survey was to determine the prevalence of use of tobacco products including smokeless tobacco during pregnancy as well as ascertain the knowledge and beliefs regarding the hazards of tobacco products on the mother and child. National Cancer Institute was one of the co-sponsors of the study. The survey at Belgaum site screened 778 women of whom 748 were eligible and among these 746 completed the survey at ten selected Primary Health Center areas of Belgaum District during November 2004 and February 2005. Although, the prevalence of tobacco smoking was very low in the study population, the use of smokeless tobacco during pregnancy and exposure to second-hand smoke in the family were significantly high. Further, awareness of the hazards of exposure to tobacco, both smoking and smokeless, on the mother and the newborn was also low calling for renewed efforts to address this important public health issue. The primary publication arising from this study has been selected for Faculty of 1000 Medicine for the year 2008. (www.f1000medicine.com)
On World Health Day, 2005, the ‘Global Network’ launched a major initiative of training community-based birth attendants in Neonatal Resuscitation for reducing early neonatal mortality in the developing world. The “First Breath: Community Based Training and Intervention in Neonatal Resuscitation” project was implemented at seven Global Network Sites located in South Asia, Africa and Central and South America including J N Medical College, Belgaum. Nearly 90 communities, 26 of them in Belgaum District, defined as geographical medical service-based area with approximately 500 births per year participated in the study aimed at comparing the efficacy of Neonatal Resuscitation Program (NRP) of the American Academy of Pediatrics with the Essential Newborn Care Course of the World Health Organization (WHO) in reducing early neonatal mortality. More than 65,000 births, approximately 26,000 of them in 298 villages with a population of more than 890,000 in Belgaum District, were assessed over the two and half year study period at the participating GN sites. As part of the trial, over 1,100 birth attendants including Private Practitioners, Nurses, Auxiliary Nurse Midwives and Traditional Birth Attendants were trained for newborn resuscitation on three occasions. The study provided resuscitation bag and masks, stethoscopes and baby weighing scales to all the birth attendants and sterilized, disposable delivery kits for all births occurring in the study villages. Preliminary results from the Belgaum component of the trial show that neonatal resuscitation training had a significant impact on increasing newborn survival from birth asphyxia. The outcome of this ambitious project, one of the largest exercises of its kind in the world, to be published shortly will likely shape policy decisions regarding future training of birth attendants across the globe.
‘Training Birth Attendants for Newborn Resuscitation’
While ‘FIRST BREATH’ attempted reduction of early neonatal mortality from birth asphyxia, it was anticipated that the survivors may end up with varying degree of neurological deficit requiring additional support for ensuring adequate growth and development. The burden on such families assumes greater significance in view of the scarcity of supportive care available to children of rural population. The site has addressed this issue by launching the “Brain Research to Ameliorate Impaired Neurodevelopment: Home-based Intervention Trial (BRAIN HIT)” to test the efficacy and feasibility of a home based early intervention program on babies resuscitated from birth asphyxia in improving their physical, mental and social development. Outcomes of 160 babies, half of them with mild to moderate neurological impairment on seventh day of life, are being evaluated at yearly intervals during the first three years of life. Trained village-based counselors are educating mothers during home visits in providing early stimulation to babies for facilitating growth and development. This project, initiated in September 2006, will aim at developing a model of home based support system for mothers of infants surviving from hypoxic insult living in remote rural villages.
‘Providing home-based support to babies and families’
The ‘Research Unit’ with a plan of ensuring sustainability of the intervention has started a ‘Child Development Center’ at Bailhongal. The expertise developed by the home-based counselors will be utilized for providing center-based support to families of babies that have been successfully resuscitated and are residing in the neighboring villages.
‘Inauguration of Child Development Center at Bailhongal –
Dr Linda Wright, Director, Global Network, NICHD’
Uncle-niece consanguineous unions are a culturally accepted norm in this part of India. To assess the adverse pregnancy outcomes, if any, of such marriages, the research unit has implemented another community based project to determine the “Association between Parental Consanguinity and Birth Weight” at four Primary Health Center areas of Belgaum District. This project was developed as part of the Global Network Scholar Training Program. The project evaluated the relationship between consanguineous marriage among blood relatives and newborn birth weight and other maternal and neonatal outcomes. Higher pregnancy losses and low birth weight appear to be associated with consanguineous marriages.