Adverse Drug Reactions in Pregnant People with Hypertension and/or Diabetes: Temporal Profile and Associated Factors.

Abstract

Background: Pregnant people, especially those with diabetes mellitus or hypertension, are particularly vulnerable to adverse drug reactions (ADRs).

Objective: To determine the incidence of and factors associated with ADRs in hospitalized pregnant people with diabetes and/or hypertension.

Methods: This prospective cohort study involved pregnant people with diabetes and/or hypertension admitted to a maternity hospital in Natal, Brazil, between August 2019 and July 2022. Data for various patient characteristics and the occurrence of ADRs were collected by means of interviewing patients and searching their medical charts. Multivariate logistic regression was used to identify and analyze the association of ADRs with various patient characteristics and other factors.

Results: A total of 571 pregnant people met the inclusion criteria. Over the study period, the incidence rate of ADRs was 634.4 (95% confidence interval [CI] 522.7-787.1) per 1000 patient-days, with 123 (21.5%) of the patients experiencing at least 1 incident. ADRs occurred predominately in the first 24 hours, with a marked decrease in frequency to the seventh day of admission. Methyldopa was identified as the cause in 42.1% (8/19) of cases of headache and 39.5% (17/43) of cases of sedation. Systemic corticosteroids were responsible for almost all cases of hyperglycemia (97.0% [32/33]). Blurred vision (82.4% [14/17]) and sedation (14.0% [6/43]) were related to the administration of antiemetics and antinauseants, especially scopolamine. Longer hospitalization time (OR 1.052, 95% CI 1.010-1.097, p = 0.016) and greater number of prescribed medications (OR 1.200, 95% CI 1.099-1.310, p < 0.001) were related to the occurrence of ADRs.

Conclusions: In this study, 1 of every 5 hospitalized pregnant people had at least 1 ADR, most often in the first 24 hours, with a decrease in incidence in the following days. Pregnant people with longer hospital stays and a greater number of medications had a higher risk of ADRs.