Last update : 01/22/2014 | Version : 1 | ID : 7613
| General | |
| Identification | |
| Detailed name | Epidepiology of severe maternal morbidity |
| Sign or acronym | EPIMOMS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n°912210 / CCTIRS n°12.060 |
| General Aspects | |
| Health determinants |
Genetic |
| Keywords | epidemiology, pregnancy, complication |
| Scientific investigator(s) (Contact) | |
| Name of the director | Bouvier-Colle |
| Surname | Marie-Hélène |
| Address | 82, av Denfert-Rochereau, 75014 Paris |
| Phone | +33 (0)1 42 34 55 72 |
| marie-helene.bouvier-colle@inserm.fr | |
| Unit |
Unité 953 Inserm de Recherche Épidémiologique sur la Santé périnatale et la Santé des Femmes et des Enfants |
| Organization | Institut national de la santé et de la recherche médicale - |
| Name of the director | Deneux-Tharaux |
| Surname | Catherine |
| Address | 82, av Denfert-Rochereau, 75014 Paris |
| Phone | +33 (0)1 42 34 55 79 |
| catherine.deneux-tharaux@inserm.fr | |
| Unit | Unité 953 Inserm de Recherche Épidémiologique sur la Santé périnatale et la Santé des Femmes et des Enfants |
| Organization | Institut national de la santé et de la recherche médicale - |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | - Institut national de la santé et de la recherche médicale - INSERM - Agence nationale de la recherche - ANR programme blanc 2010 - Agence régionale de santé - ARS Ile-de-France |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Institut national de la santé et de la recherche médicale - INSERM |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | A local referent in each maternity service is in charge of identifying severe maternal morbidity cases. |
| Database objective | |
| Main objective | Identify the frequency of complications along the pregnancy, their causes and case management. |
| Inclusion criteria | woman - adult - pregnant from 22 weeks of amenorrhea or during childbirth or having given birth during the past 42 days. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) |
| Population covered |
General population |
| Gender |
Woman |
| Geography area |
Regional |
| French regions covered by the database |
Alsace Champagne-Ardenne Lorraine Auvergne Rhône-Alpes Île-de-France Normandie |
| Detail of the geography area | 9 prenatal networks in 7 regions of France : Alsace, Auvergne, Basse-Normandie, Ile-de-France, Lorraine and Rhône-Alpes. |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 04/2012 |
| Date of last collection (YYYY or MM/YYYY) | 04/2013 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 6000 subjects - 2000 cases (women with severe maternal morbidity) - 4000 control (women without severe maternal morbidity) |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Face to face interview |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Data recorded on electronic copybook, developped by a specialized company that guarantees IT safety. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up until end of hospitalization for severe maternal morbidity. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact scientific investigator. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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