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Medication during pregnancy can lead to the occurrence of birth defects or neonatal pathologies. Thalidomide or diethylstilbestrol (Distilbene°) are prominent examples. Many drugs remain insufficiently evaluated in this area and doctors are too often deprived of relevant information when prescribing drugs in pregnant women.
To fill this gap, the investigators have put in place since 2004, a database, EFEMERIS, recording products given to women during pregnancy in Haute-Garonne (data from Primary Health Insurance Fund), fate of these pregnancies and the state health of newborns (Mother and child protection data, prenatal Diagnostic Centre and Medicalisation Program of Information Systems data).
Women included in this database (> 90 000 to date) has allowed us to study the risks of taking certain medications still not assessed in pregnant women (for example phloroglucinol, the H1N1 flu vaccine , oseltamivir ...). Each year about 10 000 pregnant women join the cohort. The collection and management of data concerning require careful organization and mobilize multiple stakeholders.
The pursuit of these inclusions is needed to study medication less often prescribed but raise questions. For example, if the investigators consider that the relative risk of cardiac abnormalities following in utero exposure to paroxetine is multiplied by 1.5, it will take 1,000 women exposed to paroxetine for 5 additional cases observed. In December 2013, 0.3% of women EFEMERIS were exposed to paroxetine in the first quarter (274 women).
The objective of this project is to continue the EFEMERIS project (funded for 10 years public tenders until December 2015) by continuing to include pregnant women (about 10 000 per year) in order to explore the potential effects of exposure to different drugs on the newborn (prematurity, birth defects, neonatal diseases).
The processing of data will EFEMERIS to detect drugs at risk to the fetus and provide a warning role in terms of malformation effects, to monitor over time prescribing practices, participate in pharmacoepidemiology international multicenter studies including similar databases in general population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Women | Medical and personal data will be collected for all the pregnant women who want to participate. The source of data are :
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary Health Insurance Fund data | Other | Data collected are:
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of risk to drug exposition in utero as assessed by descriptive analysis of data gathered | Analysis of all data collected from the four sources of information :
| Through the study completion, an average of 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of risk associated with non prescription drugs during pregnancy as assessed by descriptive analysis of data gathered | Analysis of all data collected from the four sources of information :
| Through the study completion, an average of 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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This study includes women supported by the general scheme of the Primary Health Insurance Fund of the Haute-Garonne in the framework of maternity insurance.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Damase-Michel, PHD | Contact | christine.damase-michel@univ-tlse3.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christine Damase-Michel, PHD | University of Toulouse | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Toulouse | Recruiting | Toulouse | 31000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29804133 | Result | Hurault-Delarue C, Lacroix I, Benard-Laribiere A, Montastruc JL, Pariente A, Damase-Michel C. Antidepressants during pregnancy: a French drug utilisation study in EFEMERIS cohort. Eur Arch Psychiatry Clin Neurosci. 2019 Oct;269(7):841-849. doi: 10.1007/s00406-018-0906-2. Epub 2018 May 26. |
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| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Prenatal Diagnostic Center of Toulouse University Hospital data | Other | Data collected are :
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| Mother and child protection data collection | Other | Date collected are :
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| Medicalisation Program of Information Systems data | Other | Data collected are :
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