Uso de fármacos en mujeres embarazadas y lactantes. Consecuencias en la salud de estas mujeres y en la de su descendencia (Drug use in pregnant and breastfeeding women. Outcomes in the health of the women and the offspring) (Drug use during pregnancy and breastfeeding)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Cohort + qualitative study + survey

Population studied

• Short description of the study population:
  Pregnant and lactating population, children
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  300000

Study design details

• Study design:
  Objective 1: Cohort study; Objective 2: Qualitative study; Objective 3: Observational study (survey)
• Main study objective:
  To describe use of drugs, supplements and vaccines during pregnancy and breastfeeding and the effects of this use on the health of women and their offspring.
• Setting:
  Primary Health Care, pregnant population, lactating population, offspring
• Outcomes:
  Effects of the drug use on the health of pregnant and lactating women and of their offspring. ; To develop an algorithm to identify lactation periods in women and children through electronic health records. ; To describe drug use in pregnancy and breastfeeding. ; To explore beliefs, experiences and attitudes over the drug use during pregnancy and breastfeeding from the women's perspective, their partners and the health professionals who attend them.
• Data analysis plan:
  To determine exposure to the drugs of interest during the different phases of the study we will use non-parametric models to estimate the most likely treatment using of electronic prescription and/or pharmacy dispensing records. Baseline socio-demographic and clinical data of the study population will be described by absolute and relative frequencies for categorical variables and by mean and standard deviation or median and interquartile range for continuous variables. ; In univariate models, the chi-square test or Fisher's exact test will be used for categorical variables and the Student's t-test or Mann-Whitney U-test for continuous variables. ; The assessment of maternal drug exposure and the risk of diseases and congenital abnormalities in offspring will be performed using logistic relative risk models. Adjustment for risk factors will be determined according to the characteristics of the study population.
• Summary results:
  We developed an algorithm to automatically identify the pregnancy periods in SIDIAP. We identified 327865 pregnancy episodes in 250910 people from January 2011 to June 2020. ; We described prescription drugs used during pregnancy. ; The most used ones were supplements, analgesics, NSAID or antibiotics. SIDIAP might be an efficient database to study drug safety during pregnancy and the consequences of drug use in the offspring.; We have developed two qualitative studies, where we have interviewed pregnant and lactating women, their partners and health professionals.

Documents

Study results

Pregnancy algorithm_BMJOpen2023.pdf

gomez-lumbreras-et-al-2024-drug-exposure-during-pregnancy-a-case-control-study-from-a-primary-care-database.pdf

fphar-15-1346357.pdf

e085167.full_.pdf

Study report

memòria HMA-EMA.pdf

Study publications

Ainhoa Gomez-Lumbreras, Marta Leston Vazquez, Carles Vilaplana-Carnerero, Oriol…

Marta Lestón Vázquez, Carles Vilaplana-Carnerero, Ainhoa Gomez-Lumbreras, Oriol…

Lucía Bellas, Lina Camacho-Arteaga, Maria Giner-Soriano, Albert Prats-Uribe, Cr…

Ainhoa Gomez-Lumbreras, Carles Vilaplana-Carnerero, Marta Leston Vazquez, Crist…