Use of sulfonamide-trimethoprim combinations during pregnancy in IMRD-Germany and IMRD-France

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• 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

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TRIMETHOPRIM

  SULFADIAZINE

  SULFAMERAZINE

  SULFAMETHOXAZOLE

  SULFAMETROLE

Population studied

• Short description of the study population:
  Pregnant women who have used sulfonamide and trimethoprim combination products.
• 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:
  1000

Study design details

• Main study objective:
  The aim of this study was to determine the extent of use of sulfonamide and trimethoprim combination products during pregnancy. Use of sulfonamide and trimethoprim combination products was compared to alternative antibiotics: fosfomycin, plain amoxicillin and amoxicillin in combination with clavulanic acid.
• Data analysis plan:
  All pregnant women, and all use of ‘Co-trimoxazole’, products that contain both trimethoprim and a sulfonamide (sulfadiazine, sulfamerazine, sulfamethoxazole or sulfametrole) as well as fosfomycin and amoxicillin with or without clavulanic acid during pregnancy in women were be captured. The maximum time pregnant (i.e. time window for a possible pregnancy) is calculated from the time point of the recorded pregnancy-related event and the maximum time pregnant for the specific event in accordance with Appendix 1. The denominator is any woman with a pregnancy-related event for which the maximum time pregnant includes the time period. The existence of a prescription for ‘products that contain both trimethoprim and a sulfonamide (sulfadiazine, sulfamerazine, sulfamethoxazole or sulfametrole)’, fosfomycin and amoxicillin during the maximum time pregnant is considered as exposure during pregnancy

Documents

Study results

Sulfonamide Trimethoprim in Pregnancy Results for publication