PREG-Med - Case-Control Study on the Impact of Pregnancy on Prescribing Psychotropic Medication
Head :
Apter Gisèle, Research Unit for Psychiatry and Psychopathology
Becquemont Laurent
Devouche Emmanuel
Becquemont Laurent
Devouche Emmanuel
Last update : 08/17/2016 | Version : 1 | ID : 73074
| General | |
| Identification | |
| Detailed name | Case-Control Study on the Impact of Pregnancy on Prescribing Psychotropic Medication |
| Sign or acronym | PREG-Med |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Geriatrics Psychology and psychiatry |
| Health determinants |
Intoxication Lifestyle and behavior Medicine |
| Keywords | psychotropic medication prescription; post-partum; antenatal; pregnancy |
| Scientific investigator(s) (Contact) | |
| Name of the director | Apter |
| Surname | Gisèle |
| Phone | +33 (0)1 46 74 33 99 |
| gisele.apter@gmail.com | |
| Unit | Research Unit for Psychiatry and Psychopathology |
| Organization | Erasme |
| Name of the director | Becquemont |
| Surname | Laurent |
| Phone | +33 (0)1 45 21 27 22 |
| Organization | Bicêtre Hospital |
| Name of the director | Devouche |
| Surname | Emmanuel |
| Phone | +33 (0)1 55 20 59 33 |
| emmanuel.devouche@parisdescartes.fr | |
| Organization | Institute of Psychology |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | Erasme, Institute of Psychology |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Erasme |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Case control study |
| Database recruitment is carried out by an intermediary |
An administrative base or a register |
| Base or register (detail) | Member of a social security scheme |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | To determine if and how the prescription of psychotropic medication changes during pregnancy. |
| Inclusion criteria | Women covered by a social security scheme. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
General population |
| Gender |
Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Size of the database | |
| Size of the database (number of individuals) |
Greater than 20 000 individuals |
| Details of the number of individuals | 87,213 (pregnant women); 87,213 controls |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Administrative data |
| Administrative data (detail) | Prescription of psychotropic medication |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 4 months before pregnancy; 9 months during pregnancy and 4 months after pregnancy. |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | CRAMIF database |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.journal-therapie.org/articles/therapie/abs/first/therapie140012/therapie140012.html |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge (risk that data may be removed after two years due to lack of archiving space in a rolling system). |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
