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

Contact details

Christine Damase-Michel

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
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