Incidence & factors influencing maternal near miss events in tertiary hospitals of Maharashtra, India.

Background & objectives: Government of India (GoI) released operational guidelines for maternal near miss-review (MNM-R) in 2014 for use by programme managers of public health system to assist them for conducting MNM-R. The objective of the present study was to review the incidence and factors influencing MNM events in two tertiary hospitals of Maharashtra, India, as per the operational guidelines of the GoI released in 2014 and identify delays based on three-delay model to prevent such events in future. Methods: This prospective observational study was conducted in two tertiary hospitals of Maharashtra, from July 2018 to November 2020. All women during pregnancy, childbirth or postpartum upto 42 days meeting the eligibility criteria of MNM as per the 2014 GoI guidelines were included as cases (n=228), interviewed and discussed during the monthly MNM meetings at these hospitals. Results: The incidence of MNM was 11/1000 live births; the ratio of MNM to maternal deaths was 1.2:1. Leading causes of MNM were haemorrhage (36.4%) and hypertensive disorders of pregnancy (30.3%). Haemorrhage was maximum (70.6%) in abortion and ectopic pregnancies. Majority of the women (80.2%) were anaemic, of whom 32.4 per cent had severe anaemia. Eighty six per cent of women included in the study had MNM events at the time of admission and 81 per cent were referred from lower facilities. Level one and two delays were reported by 52.6 and 32.5 per cent of women, respectively. Level three delay at referral centres and at tertiary hospitals was reported by 69.7 and 48.2 per cent of women, respectively. Interpretation & conclusions: The findings of this study suggest that MNM-R should be undertaken at all tertiary hospitals in India as per GoI guidelines to identify gaps based on three-delay model. These hospitals should implement interventions as per the identified gaps with emphasis on strengthening the infrastructure, facilities and manpower at the first-referral units.

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.

Panel of Autoimmune Markers for Noninvasive Diagnosis of Minimal-Mild Endometriosis.

Endometriosis, characterized by the presence of endometrial-like tissue at extrauterine sites, is a common, chronic, estrogen-dependent, inflammatory condition associated with pelvic pain, subfertility, dysmenorrhea, and dyspareunia, affecting about 10% of reproductive-age women in any population. The diagnosis of endometriosis is usually delayed on an average by 8 to 11 years leading to significant consequences in terms of disease progression. The current study was aimed to validate enzyme-linked immunosorbent assay based on the epitopes of stomatin-like protein 2, tropomodulin 3 (TMOD3), and tropomyosin 3 (TPM3) for diagnosis of minimal-mild endometriosis (revised American Fertility Society Classification (rAFS) stage I-II) and to compare the performance with the reported markers: cancer antigen (CA) 125, CA19-9, α-enolase, Serine/threonine-protein kinase (PDIK1L), and syntaxin 5. This was a cross-sectional, multicenter study conducted during the year 2012 to 2015. Women with minimal-mild endometriosis (rAFS stage I-II [n = 133]) and healthy controls (n = 104) were screened for 11 novel autoimmune markers and reported markers α-enolase, PDIK1L, syntaxin 5, CA-125, and CA19-9. The sensitivity and diagnostic accuracy of serum antibodies against all the 11 epitopes were higher than that of CA-125, CA19-9, α-enolase, PDIK1L, and syntaxin 5 for diagnosis of rAFS stage I to II endometriosis. The sensitivity of 6 biomarkers (anti-TMOD3b-autoAb, anti-TMOD3c-autoAb, anti-TMOD3d-autoAb, anti-TPM3a-autoAb, anti-TPM3c-autoAb, and anti-TPM3d-autoAb) was higher at the specificity of ≥80% for diagnosis of rAFS stage I to II endometriosis as well as ultrasound-negative endometriosis. Further, logistic regression models of this panel of biomarkers showed increase in sensitivity, specificity, and diagnostic accuracy than individual biomarkers. The panel of 6 autoimmune biomarkers could be useful in setting up of noninvasive diagnostic test for detection of minimal-mild endometriosis.