Drug utilisation study of macrolide-containing medicinal products during pregnancy

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Longitudinal observational study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J01F) MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS

Population studied

• Short description of the study population:
  The study included pregnant women using a phenotyping algorithm identified from IMRD databases, covering data collection from the start of each database to January 2022.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  5012

Study design details

• Main study objective:
  To develop and validate a phenotyping algorithm that identifies gestational age, to describe the use of macrolides and amoxicillin during pregnancy (Prescriptions by year, age, gravidity, and trimester of pregnancy, stratified by substance, number of prescriptions and number of distinct substances prescribed by pregnancy, Indications by substance) and to characterise the drug quantity.
• Data analysis plan:
  A phenotyping algorithm to identify pregnancy start and end dates was developed in OMOP. A descriptive analysis of the use of macrolides and amoxicillin in pregnant women identified using this phenotype. Descriptive statistics and summary tabulations of prescriptions of macrolides and amoxicillin by year, age group, gravidity (refers to the pregnancy number), trimester and indications, stratified by substance were performed. Trends of use of each substance over time, relative to number of pregnancies as determined by the phenotyping algorithm were also plotted. Drug quantity is reported as pack size, only for standard pack sizes for each solid oral formulation of erythromycin

Documents

Study results

Study Report_macrolides_in_pregnancy_20220905_For Publication_CLEAN