Experience during ‘FIRST BREATH’ trial clearly underscored the fact that registration of pregnant women and tracking them to determine the maternal and neonatal outcomes was less than desirable. Hence, true estimates of maternal/neonatal mortality and morbidity are not available in most places. The site addressed this challenge by developing a unique ‘pregnancy tracking system’ to account all pregnancy outcomes in the study area. Inspired by the success of this tracking system, the Global Network has implemented a “Maternal and Newborn Health Registry”. The objective of the registry will be to quantify and understand the trends in pregnancy outcomes in defined low-resource geographic areas over time and to provide population-based statistics on stillbirths, neonatal and maternal mortality,. The Registry is being implemented from May 2008 and will assess over 14,000 pregnancies every year over the next five years in 231 study villages of Belgaum District.
Simultaneously, the Global Network has also initiated the “Evaluation of an Emergency Obstetric and Newborn Care Intervention Package in Resource-poor settings: The EmONC trial” to address the problems associated with adverse pregnancy outcomes such as pre-eclampsia, hypertension, prolonged labor, and sepsis in the mother and preterm birth, sepsis, respiratory distress and seizures in the newborn. The intervention package will include: increasing awareness among the community members including pregnant women residing in the study villages regarding high risk conditions of pregnancy, child birth and newborn; training all birth attendants conducting deliveries in the study villages for Basic Obstetric Care using Home Based Life Saving Skills (HBLSS) modules of World Health Organization; and training all the Skilled Birth Attendants to identify, stabilize and refer any pregnant woman or newborn experiencing common complications; evaluating and strengthening quality of services at referral facilities, both public and private sector, for Emergency Obstetric and Newborn Care; and eliciting community participation for establishing communication and transportation system from villages to referral facilities. The overall goal is to eventually ensure that the community takes ownership of the program and assumes responsibility for improving the health outcomes of its mothers and children. This will strengthen the efforts of the Govt. of India in achieving the goals of the ‘National Rural Health Mission’. The project, a cluster randomized controlled trial initiated in September 2008, will be implemented at 10 of the 20 clusters of Belgaum district.
The ‘Research Unit’ is participating in a Global Network study “Development and Validation of Fundal Height Measuring Tape to Estimate Gestational Age”. The validated color coded measuring tape will help illiterate birth attendants to assess the gestational age, especially term and preterm deliveries. The tape will subsequently be used for estimation of gestational age by birth attendants for screening women for eligibility to participate in The Global Network trial of ‘Antenatal Corticosteroids in Preterm Births’.
Active Management of the Third Stage of Labour (AMTSL) reduces the occurrence of severe postpartum hemorrhage by approximately 60-70%. Active management consists of several interventions packaged together and the relative contribution of each of the components is unknown. Controlled cord traction is one of those components that require training in manual skill for it to be performed appropriately. If it is possible to dispense with controlled cord traction without losing efficacy, it would have major implications for effective management of the third stage of labour at peripheral levels of health care. The World Health Organization has taken the initiative to address this important public health question through the “Active Management of the Third Stage of Labour Without Controlled Cord Traction: A Randomized Non-Inferiority Controlled Trial”. The trial, a hospital-based, multi-centre, individually randomized controlled trial, will aim to recruit 25,000 women delivering vaginally in health facilities in eight countries – Argentina, Egypt, India, Kenya, Philippines, South Africa, Thailand and Uganda – within a 12 month recruitment period. Of these, the India site at J N Medical College, Belgaum will plan to enroll 3,000 women at the affiliated KLES Dr Prabhakar Kore Hospital & Medical Research Center and three Primary Health Centers – Kinaye, Handiganur and Vantamuri – under its administrative control. Preparations for the initiation of the trial are underway and data collection is expected to commence in the next few months.
Nutritional deficiency poses the greatest challenge to early infant growth and development. Many strategies have been undertaken to address the widespread nutritional deficiencies of zinc and iron in older infants and toddlers. Sprinkles™ are a form of micronutrient supplement which is added to foods prepared in the home at the time of consumption; the micronutrient composition typically provides iron, zinc, and varying types and amounts of other micronutrients. To inform the choice of doses of zinc and iron in Sprinkles,TM the research unit is preparing for the implementation of “A Comparison of Two Iron Doses on Zinc Absorption from Sprinkles as Micronutrient Supplement” trial. The data collection is expected to be launched in the next few months.
The ‘Research Unit’ has diversified its research activities and is developing capacity and infrastructure, recruitment and retention strategies for undertaking clinical research related to prevention methods for cervical cancer among HIV-infected women in Belgaum district through the “HIV – Cervical Cancer Prevention Research Project”. A preventive gynecologic oncology unit has been set up at KLES Dr Prabhakar Kore Hospital and Medical Research Center with substantial support from the grant. This facility is equipped with a colposcopy unit for diagnosis of cervical cancer and offers ‘Loop Electrosurgical Excision Procedure’ for women diagnosed to have pre-cancerous lesions. As a member of the consortium led by National AIDS Research Institute, Pune, it is envisaged that this unit will emerge as a nodal center for implementing trials focused on prevention and treatment of cervical cancer.