Asthma medication during pregnancy : a cohort study in EFEMERIS

Study identification

• EU PAS number:
  EUPAS7994
• Study ID:
  17493
• Official title and acronym:
  Asthma medication during pregnancy : a cohort study in EFEMERIS
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Asthma affects around 8% of pregnant women. Studies show that women experience changes in prescriptions for asthma medications during pregnancy, maybe because of concerns about their possible adverse effects on the fetus. The objective of the study is to describe asthma medications before and during pregnancy in France and to assess the possible association between asthma medications and adverse pregnancy outcomes.Women from EFEMERIS, a French database including prescribed and dispensed reimbursed drugs during pregnancy and pregnancy outcomes, who delivered between July 1, 2005 and December 31, 2012 will be included. Women with at least 2 dispensations for any asthma medication (ATC code R03) from the 30 days prior to conception through their date of delivery will be considered asthmatic. First, a description of prescription of asthma medications will be made. Second, we will compare pregnancy outcomes and newborn health between asthmatic and non-asthmatic women.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pharmacologie En Population cohorteS biobanqueS (PEPSS), Hopitaux de Toulouse

France

Study timelines

Date when funding contract was signed

Planned: 01/01/2015

Actual: 01/01/2015

Study start date

Planned: 01/01/2015

Actual: 01/01/2015

Date of final study report

Planned: 31/12/2016

Actual: 31/12/2016

Sources of funding

Other

More details on funding

Agence Nationale de Sécurité des Médicaments et produits de santé (ANSM), Clinical Research Hospital Program

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable