ITMO public health
Last update : 09/05/2017 | Version : 1 | ID : 7591
| General | |
| Identification | |
| Detailed name | Mode of delivery and term breech presentation in the PREMODA cohort. |
| Sign or acronym | PREMODA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Autorisation CNIL |
| General Aspects | |
| Health determinants |
Genetic |
| Keywords | Breech presentation, Term pregnancy, Mode of delivery |
| Scientific investigator(s) (Contact) | |
| Name of the director | Goffinet |
| Surname | François |
| Address | 123 Bd de Port-Royal, 75 014 Paris |
| Phone | +33 (0)1 42 34 55 73 |
| francois.goffinet@cch.aphp.fr | |
| Unit |
CIC901 CIC - GH NECKER-COCHIN-PARIS CENTRE DESCARTES Équipe/activité : Recherche clinique U953 Recherche épidémiologique en santé périnatale et santé des femmes et des enfants Équipe/activité : Épidémiologie clinique et organisation des soins |
| Organization | Assistance Publique - Hôpitaux de Paris Hôpital Cochin - AP-HP ; Institut national de la santé et de la recheche médicale - |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | - Direction de la recherche clinique de l'assistance publique des hôpitaux de Paris - AP-HP - Institut national de la santé et de la recherche médicale - INSERM - Collège National des Gynécologues et Obstétriciens Français - Société Française de Médecine Périnatale - Fonds National de la Recherche Scientifique |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Assistance Publique - Hôpitaux de Paris Hôpital Cochin - AP-HP |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Institut national de la santé et de la recheche médicale - INSERM |
| 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 |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | All women with breech presentation delivering in one of the participating maternities were included. |
| Database objective | |
| Main objective | The purpose of this work was to report labor and birth management practices for term breech presentation in France and Belgium in 2001-2002 and to describe indications for cesarean sections (before labor, emergency situations) in breech presentations. |
| Inclusion criteria | woman - adult - term of pregnancy greater than or equal to 37 weeks of amenorrhea - single pregnancy |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) |
| Population covered |
General population |
| Gender |
Woman |
| Geography area |
International |
| Detail of the geography area | Mainland France and Belgium. |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 06/2001 |
| Date of last collection (YYYY or MM/YYYY) | 05/2002 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | - 18067 subjects - 8 105 cases (présentations du siège) - 9 962 témoins (présentations céphaliques) |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Direct physical measures |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Prospective collection of data in 135 maternities in France, representing 225 999 births/year and in 36 maternities in Belgium from 1 January 2002 to 31 December 2002 representing 37 195 births/year. |
| Participant monitoring |
Yes |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ajog.org/article/S0002-9378%2805%2902440-3/abstract |
| 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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