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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