PréCARE - Cohort of Socially Vulnerable Females
Head :
Azria Elie, INSERM Unit 953
Estellat Candice
Ravaud Philippe, Department of Epidemiology and Biostatistics
Estellat Candice
Ravaud Philippe, Department of Epidemiology and Biostatistics
Last update : 08/17/2016 | Version : 1 | ID : 5015
| General | |
| Identification | |
| Detailed name | Cohort of Socially Vulnerable Females |
| Sign or acronym | PréCARE |
| General Aspects | |
| Medical area |
Gynecology/ obstetrics |
| Health determinants |
Social and psychosocial factors |
| Keywords | pregnant women, social factors, prospective, cohort, multicentric, hospitalisation |
| Scientific investigator(s) (Contact) | |
| Name of the director | Azria |
| Surname | Elie |
| Address | Service de gynécologie obstétrique Hôpital Bichat 46, rue Henri Huchard 75018 Paris |
| Phone | +33 (0)1 40 25 76 57 |
| eazria@hpsj.fr | |
| Unit | INSERM Unit 953 |
| Organization | Paris Public Hospitals |
| Name of the director | Estellat |
| Surname | Candice |
| candice.estellat@bch.aphp.fr | |
| Organization | Paris Public Hospitals |
| Name of the director | Ravaud |
| Surname | Philippe |
| Phone | AP-HP |
| philippe.ravaud@htd.aphp.fr | |
| Unit | Department of Epidemiology and Biostatistics |
| Organization | +33 (0)1 58 41 41 41 |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | PHRC (Hospital clinical research programmes) 2007 and 2012 |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Paris Public Hospitals (AP-HP) |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort 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 |
| Database objective | |
| Main objective |
Main objective
To assess the impact of maternal vulnerability factors on childbirth, child and maternal outcome, as well as break down the mechanisms linking vulnerable conditions to increased perinatal and maternal risk. Secondary aims: — to study the impact of serious events on vulnerable women by exclusive monitoring in one hospital in relation to monitoring within the city hospital network; — to study the treatment path for vulnerable women; — to answer questions posed by additional studies; — to identify risk factors of increased post-partum haemorrhaging; — assess the impact of maternal vulnerability on immunobiological development in HIV-infected pregnant women (in partnership with the EPF-ANRS cohort) — assess the impact of maternal vulnerability on systemic errors and avoiding such errors in relation to the onset of serious adverse events during pregnancy: (PREVIANS) — Definition of normal values for various biological markers (PreCARE Bio) — to identify social and economic factors that determine healthcare consumption in pregnant women (URC ECO APHP) — to identify social and economic factors that determine healthcare consumption in newborns (0 to 28 days old) (URC ECO APHP) |
| Inclusion criteria | All women registered to give birth or giving birth in one of 4 maternity units in participating centres (Bichat-Claude Bernard, Robert Debré, Louis Mourier, Beaujon). |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) |
| Population covered |
General population |
| Gender |
Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 10/2010 |
| Date of last collection (YYYY or MM/YYYY) | 12/2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | 10,413 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures |
| Details of collected clinical data | Pregnancy follow-up, maternal morbidity/mortality, neonatal morbidity/mortality |
| Declarative data (detail) |
Paper self-questionnaire |
| Details of collected declarative data | Isolation, vulnerability, income, social status |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Data on vulnerability collected by self-administered questionnaire at start of pregnancy, as well as medical data through summary sheets completed by midwives or obstetricians. Data that is hopefully clearly indicated in the medical record (demographic data, date of pregnancy, due date, etc.) may be collected retrospectively. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 6 months |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | Cross-referencing with PMSI (Medical Information System Programme) and SNIIR-AM (National Health Insurance Cross-Schemes Information System) databases is planned in order to gather data regarding hospital re-admissions and overall healthcare use.. |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | To be decided. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
