Study identification

PURI

https://redirect.ema.europa.eu/resource/16888

EU PAS number

EUPAS5356

Study ID

16888

Official title and acronym

Veinotonics in pregnancy: a comparative study in the EFEMERIS database

DARWIN EU® study

No

Study countries

France

Study description

There are few published data about possible effects of veinotonics in pregnant women. However, many French women use these medications during their pregnancy. The aim of the study is to investigate potential adverse drug reactions of veinotonics in pregnancy. The study is conducted in EFEMERIS, a database including prescribed and dispensed reimbursed drugs during pregnancy (data from Caisse Primaire d'Assurance Maladie of Haute-Garonne) and outcomes (data from Maternal and Infant Protection Service and from Antenatal diagnosis Centre). Women who delivered from July 1st 2004 to December 31th 2007 in Haute-Garonne (time period when veinotonics were still reimbursed) and were registered in the French Health Insurance Service have been included. We compare pregnancy outcomes and newborn health between women exposed to veinotonics during pregnancy and unexposed women.

Study status

Finalised
Research institutions and networks

Institutions

University of Toulouse 3 and INSERM 1027

Contact details

Christine Damase-Michel

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), the 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