COroFET - Clinical and laboratory epidemiological monitoring of pregnant women with evaluation of the obstetric, foetal and neonatal risk associated with SARS-CoV-2 during the COVID-19 pandemic COroFET
Head :
DUBUCS Charlotte, IUCT-Oncopole Pathology Department
Last update : 05/05/2021 | Version : 1 | ID : 73499
| General | |
| Identification | |
| Detailed name | Clinical and laboratory epidemiological monitoring of pregnant women with evaluation of the obstetric, foetal and neonatal risk associated with SARS-CoV-2 during the COVID-19 pandemic COroFET |
| Sign or acronym | COroFET |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CPP2020-04-039 / 2020-A00870-39 / 20.04.07.83722 |
| General Aspects | |
| Medical area |
Anatomy - Cytology Gynecology/ obstetrics Infectious diseases |
| Study in connection with Covid-19 |
Yes |
| Scientific investigator(s) (Contact) | |
| Name of the director | DUBUCS |
| Surname | Charlotte |
| Address | 1 avenue Irène Joliot-Curie<br>31100 TOULOUSE |
| Phone | 531156193 |
| dubucs.charlotte@iuct-oncopole.fr | |
| Unit | IUCT-Oncopole Pathology Department |
| Organization | Toulouse University Hospital |
| Collaborations | |
| Funding | |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Toulouse University Hospital |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Others |
| Specify | Clinical and laboratory database (containing clinical and paraclinical data associated with a biological and tissue collection on pregnancy outcomes) |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | In this situation in which data are crucial to understanding the effects of SARS-CoV-2 in the pregnant female population, our primary objective is to collect clinical and paraclinical data from a large sample of women recruited from our level 3 maternity unit, and to create biological and tissue collections with a view to responding to a series of questions, partly explained in the research programme, but which may also evolve as knowledge progresses. |
| Inclusion criteria |
Adult females aged 18 years or over at the date of inclusion
Pregnant women giving birth at the Paule de Viguier maternity unit, Toulouse University Hospital, in the study, between April 2020 and April 2021, regardless of pregnancy outcome (live births, intrauterine foetal death, termination of pregnancy, i.e. miscarriages, medical termination of pregnancy) and term Women having given their consent to take part in the study Women registered with a social security scheme (including the state welfare scheme) |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) |
| Population covered |
General population |
| Pathology | |
| Gender |
Woman |
| Geography area |
Regional |
| French regions covered by the database |
Languedoc-Roussillon Midi-Pyrénées |
| Detail of the geography area | Toulouse |
| Data collection | |
| Dates | |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | target 3,600 by end April 2021 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Cord blood Fluids (saliva, urine, amniotic fluid, …) Tissues |
| Procedures | |
| Participant monitoring |
No |
| Followed pathology | |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access |
