Assessing exposure to cardiovascular therapy, anxiety depressive syndrome treatment and anti-infectives during pregnancy and breastfeeding (Drug exposure in pregnancy and breastfeeding)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Population-based observational study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (C01BA) Antiarrhythmics, class Ia

  Antiarrhythmics, class Ia

  (C07FB) Beta blocking agents and calcium channel blockers

  Beta blocking agents and calcium channel blockers

  (C08E) NON-SELECTIVE CALCIUM CHANNEL BLOCKERS

  NON-SELECTIVE CALCIUM CHANNEL BLOCKERS

  (N06A) ANTIDEPRESSANTS

  ANTIDEPRESSANTS

  (N05B) ANXIOLYTICS

  ANXIOLYTICS

Population studied

• Short description of the study population:
  The study population involved pregnant women aged 12-50 years and their offspring identified from the SIDIAP database during the study period of 2011 to 2020. ; Inclusion criteria:;  Women from 12-50 years ;  Women identified with a pregnancy code during the study period (2011-2020);  Women with at least one visit registered in primary care/ASSIR during the study period
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  200000

Study design details

• Main study objective:
  a) To analyse drug use during pregnancy b) To analyse drug use during breastfeeding c) To analyse diagnoses in the offspring of mothers with drug exposure during pregnancy and breastfeeding d) To analyse SARS-Co-V2 infection in pregnant women
• Data analysis plan:
  All processes of data management and statistical analysis will be carried out using statistical package R 3.3 (2016). At the exploratory level, the demographic data and baseline characteristics of the study population will be described using relative and absolute frequencies for the categorical and mean variables, standard or median deviation and interquartile range for the continuous variables. In the bivariate analysis, we will consider the Chi-square test or the Fischer exact test for categorical variables and the Student t test or Mann-Whitney U test for continuous variables according to their distribution. The evaluation of mothers’ drugs exposures and the risk of diseases and congenital outcomes in their offspring will be carried out by means of multiple logistic regression models or proportional risk models (Cox). The adjustment for risk factors will be determined based on the characteristics of the study population.