Leptospirosis in Pregnancy: Prevalence, Risk Factors, Clinical Characteristics, and Outcomes in a North Indian Population

Introduction Leptospirosis, a neglected zoonotic disease bears a significant global burden and is endemic in India. Leptospirosis in pregnancy can lead to severe adverse outcomes but is often misdiagnosed and underreported as clinical presentation is masked by the symptoms of common obstetric complications and other endemic infectious diseases. Our aim was to generate epidemiological information on the prevalence and distribution, risk factors, and outcomes (both maternal and fetal) of the disease among a population of pregnant and post-partum women in northern India. Methods We conducted a cross-sectional study on a random sample of 170 pregnant and post-partum women in 10 hospitals across three northern states of India in whom ELISA IgG and IgM antibody tests were done. Women were categorised as seropositive if they had high levels of either IgG or IgM. We identified study variables based on an available systematic review of leptospirosis in pregnancy. Fisher’s Exact and Wilcoxon rank-sum non-parametric tests were used to analyse the association between leptospirosis in pregnancy and a range of socio-demographic and clinical factors. An analysis of the geographical distribution of the seropositive cases was undertaken using Geographical Information System mapping. Results The prevalence of leptospirosis in pregnancy was 5.9% (95% CI: 2.85 – 10.55%) with 80% of the seropositive cases living near water sources and lowlands. Proportions of cardiac problems, raised liver enzymes, anaemia and adverse fetal outcomes were higher among women who were seropositive compared with women who were seronegative. Adverse maternal and fetal outcomes were more common among seropositive pregnant and post-partum women compared with seronegative women. Conclusions This is the first descriptive epidemiological study of leptospirosis in pregnancy in India that generates important hypotheses emphasizing the need for further research. Pregnant women in endemic regions should be screened for leptospirosis for early diagnosis and treatment to avoid adverse outcomes. Author Summary Leptospirosis bears a significant global burden and is endemic in India. In pregnancy, it can lead to serious complications, but leptospirosis in pregnancy is often misdiagnosed and underreported as clinical presentation of the disease is masked by the symptoms of common obstetric complications and other endemic infectious diseases. There are no detailed studies about leptospirosis in pregnancy in India with almost all published studies being case reports. In recognition of this limitation, this cross-sectional study was undertaken to understand the rates, risk factors and outcomes of leptospirosis in pregnancy in India. ELISA IgG and IgM antibody tests were conducted to determine the seroprevalence of leptospirosis in the population. The rate of leptospirosis in pregnancy in our study population was found to be 5.9%. A majority of the seropositive cases lived near water sources and lowlands. The adverse clinical presentation of cardiac problems, raised liver enzymes, anaemia and adverse fetal outcomes were observed to be more common among seropositive pregnant and post-partum women compared with seronegative women. The study highlights the need for more research and for screening of leptospirosis in pregnant women living in endemic regions for early diagnosis and treatment to avoid adverse outcomes. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This study was funded by a Medical Research Council Career Development Award to MN (Ref: MR/P022030/1). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by the institutional review boards (IRB) of each coordinating Indian institution, namely: Srimanta Sankaradeva University of Health Sciences, Guwahati, Assam Nazareth hospital, Shillong, Meghalaya Emmanuel Hospital Association, New Delhi and the Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh. It also received approval from the Government of India’s Health Ministry’s Screening Committee, the Indian Council of Medical Research, New Delhi and by the Oxford Tropical Research Ethics Committee (OxTREC), University of Oxford, UK. Written informed consent was taken from all participants. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data available for this study are included in the paper and can also be obtained for free. Information on how to access data is available on Oxford Population Health Department’s website (https://www.ndph.ox.ac.uk/data-access) and requests can also be emailed directly to data.access@ndph.ox.ac.uk.