Drug related adverse pregnancy outcomes at a tertiary care hospital from the foothills of Himalayas: A Prospective observational study

Context and Aim: Safety of drug usage during pregnancy is of utmost importance. Unrestricted usage of drugs may lead to undesirable and unpredictable pregnancy outcomes. This study was designed to detect drug-related adverse pregnancy outcomes, perform prescription audit and develop a pregnancy drug registry. Methods and Materials: A prospective observational study was conducted at a tertiary care hospital in northern India. Pregnant females attending antenatal clinic, irrespective of their duration of pregnancy were included in the study over a period of 1 year. The participants were followed up monthly during their pregnancy till the pregnancy outcome. Adverse pregnancy outcomes were evaluated and causality assessment was done using the WHO-UMC scale. Statistical Analysis: Descriptive and inferential statistical tools were used for appropriate variables. Regression model was used to establish relationship between factors proposed to be responsible for adverse pregnancy outcomes. Presence of adverse pregnancy outcome was used as an independent variable. Microsoft Excel and Strata (version 12) were used for statistical analysis. Results: A total 326 pregnant women were screened out of which 305 were included in the final analysis. Mean age of participants was 27.82 (+/- 4.51) years. Pre-existing comorbidities were present in 4.26% of participants. Average number of drugs per participant was 6.32 (+/- 1.94). Most drugs prescribed to participants were from FDA category B (49.23%) and category A (33.60%). Mean ADR reported per patient was 1.16 (+/- 1.18) with involvement of musculoskeletal (56.42%) and gastrointestinal (7.16%) being most frequent. Adverse pregnancy outcomes were reported in 25 participants among which IUGR (24%) followed by IUD (20%) and ectopic pregnancy (16%) were most frequently observed. Multivariate logistic regression showed number of comorbidities (P = 0.037) and number of drugs consumed during pregnancy (P = 0.02) to be statistically significantly associated with occurrence of adverse pregnancy outcome. Conclusions: Pregnancy registries have been instrumental in detection of signals for further research in drug-related adverse outcomes. Inappropriate usage of drugs has been shown to be associated with adverse pregnancy outcomes. Our study warrants need for further well-designed studies on adverse pregnancy outcomes in larger patient populations.