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Abstract
BackgroundCommonly used drugs in pregnant women include antihypertensives, hypoglycemic agents, analgesics, antimicrobials, antiemetics and antispasmodics but the use of medicines during pregnancy, especially in high-risk pregnancy, may be associated with high risk of adverse drug reactions (ADR). The objective of this study was to determine the risk of an adverse drug reaction in hospitalized high-risk pregnant women and the factors associated with their occurrence.MethodsThe study received IRB approval and all patients gave written informed consent. Observational cohort study conducted from September 2015 to November 2016 in 1070 pregnant women consecutively admitted to the high risk sector of the University Maternity Januário Cicco in Brazil. ADR were detected through daily active search. Risk factors for the occurrence of ADR were determined using multivariate logistic regression.ResultsThe mean age of the study population was 26.2 ± 7.2 years and gestational age was 31.2 ± 7.2 weeks. The average number of previous pregnancies was 2.4 ± 1.8 and 46.4% reported cases of previous abortion/miscarriage. ADR were observed in 10.7% of women. The main medicines involved, with the incidence rate of ADR per 100 prescriptions of the drug (IR), were parenteral scopolamine (IR 14.9%), methyldopa (IR 15.9%), insulin (IR 8.46%), oral scopolamine (IR 3.58%), captopril (IR 2.38%) and ceftriaxone (IR 18.4%). Multivariate analysis showed that only gestational age in weeks (odds-ratio 0.97, 95% confidence interval 0.95–0.98) was related to the occurrence of adverse reactions.ConclusionLower gestational age is a risk factor for high-risk pregnant women, increasing the likelihood of adverse reactions, with parenteral medications being those that have the highest potential risk of harm.
Highlights
Used drugs in pregnant women include antihypertensives, hypoglycemic agents, analgesics, antimicrobials, antiemetics and antispasmodics but the use of medicines during pregnancy, especially in high-risk pregnancy, may be associated with high risk of adverse drug reactions (ADR)
A few studies have estimated the incidence of ADR during pregnancy at around 10% [14, 16, 17], but in general they were based on small samples and the identification of ADR was not through active search
Our study involved the active search for ADRs in over one thousand high-risk pregnant women observed throughout their stay in a specialized unit over a period of 15 months in a reference maternity school and the main findings of this study were that about 1 out of 9 high-risk pregnancies admitted to a hospital will develop one or more ADRs, that parenteral scopolamine and oral methyldopa are the medications most frequently involved in ADRs, that parenteral drugs such as scopolamine, ceftriaxone and insulin have the greatest risk of ADR
Summary
Used drugs in pregnant women include antihypertensives, hypoglycemic agents, analgesics, antimicrobials, antiemetics and antispasmodics but the use of medicines during pregnancy, especially in high-risk pregnancy, may be associated with high risk of adverse drug reactions (ADR). The objective of this study was to determine the risk of an adverse drug reaction in hospitalized high-risk pregnant women and the factors associated with their occurrence. The drugs involved and the clinical manifestations of ADR have not been adequately described and, to the best of our knowledge, no studies have yet attempted to identify risk factors for the occurrence of ADR. The aim of this study was to estimate, in hospitalized high-risk pregnancy, the risk and type of adverse drug reactions, the drugs more often involved, and the patient factors at admission that may predict their occurrence
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