Incidence of Adverse Drug Reactions in High-Risk Pregnancy: A Prospective Cohort Study in Obstetric Intensive Care.

Purpose: To estimate the cumulative incidence of adverse drug reactions (ADRs) in women with high-risk pregnancy hospitalized in an obstetric intensive care unit, then to describe the medicines involved and to identify major risk factors. Methods: From June 2016 to December 2017, patients admitted t...

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Publicado en:European Journal of Clinical Pharmacology Vol. 76; no. 2; pp. 291 - 299
Autores principales: da Costa, Tatiana Xavier, de Almeida Pimenta Cunha, Marta Danielle, do Vale Bezerra, Priscilla Karilline, Azeredo, Francine Johansson, Martins, Rand Randall, Oliveira, Antonio Gouveia
Formato: algorithm research tables/charts Journal Article
Publicado: Springer Nature Feb2020
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Feb2020
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      pub: Springer Nature
      place: New York, New York
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        10.1007/s00228-019-02789-9
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        atl: Incidence of Adverse Drug Reactions in High-Risk Pregnancy: A Prospective Cohort Study in Obstetric Intensive Care.
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          da Costa, Tatiana Xavier
          de Almeida Pimenta Cunha, Marta Danielle
          do Vale Bezerra, Priscilla Karilline
          Azeredo, Francine Johansson
          Martins, Rand Randall
          Oliveira, Antonio Gouveia
        affil: Postgraduate Program in Pharmaceutical Sciences, Centro de Ciências da Saúde, Universidade Federal do Rio Grande do Norte, Natal, Brazil
      sug:
        subj:
          Pregnancy, High Risk
          Adverse Drug Event Epidemiology
          Adverse Drug Event Risk Factors
          Obstetric Care
          Intensive Care Units
          Risk Assessment
          Human
          Pregnancy
          Female
          Patient Admission
          Nonexperimental Studies
          Prospective Studies
          Medical Records
          Algorithms
          Univariate Statistics
          Multiple Logistic Regression
          Young Adult
          Adult
          Gestational Age
          Severity of Illness
          Magnesium Sulfate Adverse Effects
          Disorders of Excessive Somnolence Risk Factors
          Hypotension Risk Factors
          Blood Pressure
          Hemoglobins Blood
          Odds Ratio
          Body Temperature
          Adult: 19-44 years
          Female
      ab: Purpose: To estimate the cumulative incidence of adverse drug reactions (ADRs) in women with high-risk pregnancy hospitalized in an obstetric intensive care unit, then to describe the medicines involved and to identify major risk factors. Methods: From June 2016 to December 2017, patients admitted to the ICU with high-risk pregnancy were considered eligible in this observational, longitudinal, prospective study. Patients were investigated daily for the occurrence of ADRs through pharmaceutical anamnesis, active search in medical records and questioning of the health team. Suspected ADRs were classified according to Naranjo's algorithm. Written informed consent was obtained from all patients. Univariate and multivariate logistic regression were used to identify risk factors of ADR. Results: The study population consisted of 607 high-risk pregnancies from 851 women admitted to the ICU, of whom 244 admitted for non-obstetric conditions, with an ICU stay less than 24 h or readmitted to the ICU were excluded. The mean age was 27.0 ± 7.5 years-old, mean gestational age was 33.8 ± 6.3 weeks. ADR were observed in 165 women (27.2%). No severe ADR was observed and 29.7% were of moderate severity. The most often implicated medicine was magnesium sulphate (25.2%) with 44.5% of patients administered that substance experiencing ADRs consisting of somnolence (68.6%), absent patellar reflex (21.6%) and hypotension (9.8%). Risk factors of ADR were blood pressure (adjusted odds-ratio (aOR) 1.02), haemoglobin level (aOR 1.21) and body temperature (aOR 0.71). Conclusions: ADRs affect about one third of high-risk pregnancies, mainly due to magnesium sulphate administrations. High blood pressure, lower body temperature, and high haemoglobin concentration on admission were associated with an increased risk of ADR.
      pubtype: Academic Journal
      doctype:
        algorithm
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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