Abstract
Introduction
Congenital malformations (CMFs) are a major public health problem in India. Consanguineous marriages, infections during pregnancy, folic acid deficiency during the periconceptional period, exposure to pesticides and a history of intake of drugs during pregnancy have been hypothesized as risk factors. Drugs include oral contraceptive pills, progesterone analogues, medications for ailments and indigenous drugs to bear male offspring. It is important to analyze the risk factors in order to implement preventive measures. The prime objective of this study was to study the risk factors of visible structural CMFs, with a focus on indigenous medicines for sex selection.
Methods
A population-based, case-control study was undertaken in Haryana state. Cases included children (0–18 months) with any apparent structural deformity as reported by various Government sources. A consecutive birth from the same area as the case was labelled and included as the control. The sample size calculated was 175 in each group. Mothers of every case and control were interviewed at their respective homes using a structured tool. Descriptive analysis, bivariate analysis, followed by logistic regression was conducted to establish the association between risk factors and CMFs.
Results
The sociodemographic profiles of the cases and controls were similar. Among the various risk factors studied, more than two living children (unadjusted odds ratio [OR] 1.6, 95 % CI 1.04–2.4) and intake of sex-selection drugs (unadjusted OR 2.8, 95 % CI 1.6–5.1) were significant risk factors on bivariate and regression analyses. The risk of having a child with CMFs was threefold more among mothers with a history of intake of indigenous medicines for sex selection (adjusted OR 3; 95 % CI 1.7–5.6).
Conclusions
The intake of indigenous drugs during pregnancy increased the risk of CMFs almost threefold. This has social as well as economic implications, and hence needs further investigation.
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Acknowledgments
The research team acknowledges the contribution of Dr. Amit Phogat, Dr. Rupinder Sahota and Dr. Deepika Gupta from the National Health Mission, Haryana, India, for the support they extended during the completion of the study. The team also appreciates the work of its research associates, Mr. Shamlal Sikri and Dr. Sapna Chopra from the Indian Institute of Public Health–Delhi, for their contribution towards data collection, and of Mr. Manoj Soni, Data Management and Support Unit, Indian Institute of Public Health–Delhi, for helping the team with database development and data management. The authors are grateful to Professor Pat Doyle, Department of Epidemiology, London School of Hygiene and Tropical Medicine, for her contribution in improving the manuscript.
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The National Health Mission, Government of Haryana, India, provided financial assistance to conduct the study described in this article.
Conflicts of interest
Sutapa Bandyopadhyay Neogi, Preeti H. Negandhi, Navraj Sandhu, Ravi Kant Gupta, Abhijit Ganguli, Sanjay Zodpey, Amarjeet Singh, Arun Singh and Rakesh Gupta have no conflicts of interest that are directly relevant to the content of this study.
Ethical approval
Permission was sought from the state and district authorities before initiating the study. Approval was obtained from Institutional Ethics Committees of the Indian Institute of Public Health–Delhi, Public Health Foundation of India.
Patient consent
The project team provided potentially eligible parents with detailed information about the study, in the local language. Written consent was provided by every mother who voluntarily agreed to participate in the study. Confidentiality of the information collected was maintained at every level.
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Neogi, S.B., Negandhi, P.H., Sandhu, N. et al. Indigenous Medicine Use for Sex Selection During Pregnancy and Risk of Congenital Malformations: A Population-Based Case-Control Study in Haryana, India. Drug Saf 38, 789–797 (2015). https://doi.org/10.1007/s40264-015-0309-5
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DOI: https://doi.org/10.1007/s40264-015-0309-5