Protocol for a case-control study investigating the clinical phenotypes and genetic regulation of endometriosis in Indian women: the ECGRI study.

INTRODUCTION: Endometriosis is one of the common, gynaecological disorders associated with chronic pelvic pain and subfertility affecting ~10% of reproductive age women. The clinical presentation, etiopathogenesis of endometriosis subtypes and associated risk factors are largely unknown. Genome-Wide Association (GWA) Studies (GWAS) provide strong evidence for the role of genetic risk factors contributing to endometriosis. However, no studies have investigated the association of the GWAS-identified single-nucleotide polymorphism (SNPs) with endometriosis risk in the Indian population; therefore, one-sixth of the world's population is not represented in the global genome consortiums on endometriosis. The Endometriosis Clinical and Genetic Research in India (ECGRI) study aims to broaden our understanding of the clinical phenotypes and genetic risks associated with endometriosis. METHODS AND ANALYSIS: ECGRI is a large-scale, multisite, case-control study of 2000 endometriosis cases and 2000 hospital controls to be recruited over 4 years at 15 collaborating study sites across India covering representative Indian population from east,north-east, north, central, west and southern geographical zones of India. We will use the World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonisation Project (WERF-EPHect) data collection instruments for capturing information on clinical, epidemiological, lifestyle, environmental and surgical factors. WERF-EPHect standard operating procedures will be followed for the collection, processing and storage of biological samples. The principal analyses will be for main outcome measures of the incidence of endometriosis, disease subtypes and disease severity determined from the clinical data. This will be followed by GWAS within and across ethnic groups. ETHICS AND DISSEMINATION: The study is approved by the Institutional Ethics Committee of Indian Council of Medical Research-National Institute for Research in Reproductive Health and all participating study sites. The study is also approved by the Health Ministry Screening Committee of the Government of India. The results from this study will be actively disseminated through discussions with endometriosis patient groups, conference presentations and published manuscripts.

"Near miss" obstetric events and maternal deaths in a tertiary care hospital: an audit.

OBJECTIVES: (1) To determine the frequency of maternal near miss, maternal near miss incidence ratio (MNMR), maternal near miss to mortality ratio and mortality index. (2) To compare the nature of near miss events with that of maternal mortality. (3) To see the trend of near miss events. DESIGN: Audit. SETTING: Kasturba Hospital, Manipal University, Manipal, India. POPULATION: Near miss cases & maternal deaths. METHODS: Cases were defined based on WHO criteria 2009. MAIN OUTCOME MEASURES: Severe acute maternal morbidity and maternal deaths. RESULTS: There were 7390 deliveries and 131 "near miss" cases during the study period. The Maternal near miss incidence ratio was 17.8/1000 live births, maternal near miss to mortality ratio was 5.6 : 1, and mortality index was 14.9%. A total of 126 cases were referred, while 5 cases were booked at our hospital. Hemorrhage was the leading cause (44.2%), followed by hypertensive disorders (23.6%) and sepsis (16.3%). Maternal mortality ratio (MMR) was 313/100000 live births. CONCLUSION: Hemorrhage and hypertensive disorders are the leading causes of near miss events. New-onset viral infections have emerged as the leading cause of maternal mortality. As near miss analysis indicates the quality of health care, it is worth presenting in national indices.