Drug utilisation study of macrolide-containing medicinal products during pregnancy

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/104297
• EU PAS number:
  EUPAS104296
• Study ID:
  104297
• Official title and acronym:
  Drug utilisation study of macrolide-containing medicinal products during pregnancy
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  United Kingdom
• Study description:
  A a longitudinal observational cohort study to (1) develop and validate a phenotyping algorithm that identifies gestational age, (2) describe the use of macrolides and amoxicillin during pregnancy, and (3) characterise the drug quantity, namely number of units prescribed in tablets or capsules, of Erythromycin by trimester of pregnancy.
• Study status:
  Finalised

Research institution and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 23/05/2022

Actual: 23/05/2022

Study start date

Planned: 23/05/2022

Actual: 23/05/2022

Date of final study report

Planned: 06/09/2022

Actual: 05/09/2022

Sources of funding

EMA

Study protocol

Initial protocol

Analysis Plan_macrolides_in_pregnancy_20220905_For Publication_CLEAN

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable