Study identification

EU PAS number

EUPAS3057

Study ID

40624

Official title and acronym

Venlafaxine exposure in pregnancy, a multicenter ENTIS study

DARWIN EU® study

No

Study countries

Finland
France
Israel
Italy
Netherlands
Switzerland

Study description

Introduction Venlafaxine (Efexor®) is a serotonin and noradrenaline reuptake inhibitor (SNRI) used for the treatment of depression and anxiety disorders. The limited data on the use of venlafaxine in human pregnancy do not indicate an increased risk of congenital malformations. The main purpose of the study is to assess the rate of major malformations after first trimester exposure to venlafaxine. Methods This multicenter, prospective cohort study was performed using data from eight centers who are member of the European Network of Teratology Information Services (ENTIS). Data on pregnancy and pregnancy outcome of women who used venlafaxine in pregnancy were collected during individual risk counseling. Standardized procedures for data collection and follow-up were used by each center.

Study status

Ongoing
Research institutions and networks

Institutions

Centre de Référence sur les Agents Tératogènes (CRAT) Paris, France, Florence Teratology Information Service, Careggi university hospital Florence, Italy, CEPIG, Genetica Clinica, Azienda Ospedaliera Padov Padova, Italy, Poison Control Centre and Teratology Information Service, Ospedali Bergamo, Italy, Swiss Teratogen Information Service and Division of clinical Pharmacology and Toxicology, University Hospital, Lausanne Lausanne, Switserland, BELTIS Rabin. Medical. Center Petah-Tikva Affiliated with the Sackler School of Medicine, Tel Aviv University Tel Aviv, Israel, Telefono Rosso, Catholic University of Sacred Heart Rome, Italy

Networks

Contact details

Bernke te Winkel

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Ministery of Health, The Netherlands
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable