Adverse drug reactions monitoring in the third trimester pregnant women from rural population of central India visiting tertiary care hospital: A cross- sectional pharmacovigilance study

Background: Pregnant women are often excluded from clinical trials, hence information about safety of medications during pregnancy is limited. This study aimed at assessing the prevalence of adverse drug reactions in 3rd trimester pregnancy and effect of demographic factors in reporting the ADR. Methods: This study includes 3rd trimester pregnant women visiting outpatient and inpatient department of Obstetrics and Gynecology of tertiary care hospital situated in rural part of central India from February 2021 to December 2022 using convenience sampling method. Patients were followed up on future visits or telephonically after 15 days of medication administration date. Results: A total of 66 (16.33%) suspected ADR events in 44(11%) women were detected in 404 enrolled patients in our study. Out of the total 66 ADRs reported in the 44 patients, nausea was the most frequent adverse reaction reported with 45.45% prevalence followed by constipation (43.18%), headache (18.18%) and loose stools (6.81%). The 46 ADR (69%) out of 66 were assigned POSSIBLE on causality assessment and remaining 20 (30%) ADRs were assigned as PROBABLE as per Naranjo’s Adverse Reaction Probability Scale. The ADRs were significantly higher in multipara, urban and women with higher annual family income. Conclusion: Adverse drug reactions are very common[1] in third trimester pregnant women and demographic factors like parity, socioeconomic status impact them significantly. Further studies with a re-challenge test will be needed for more information about ADR prevalence.