EFEMERIS: Evaluation of Drug's Risk in Pregnant Women
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pregnant Women Medical and personal data will be collected for all the pregnant women who want to participate. The source of data are : Primary Health Insurance Fund data Prenatal Diagnostic Center of Toulouse University Hospital data Mother and child protection data collection Medicalisation Program of Information Systems data |
Other: Primary Health Insurance Fund data
Data collected are:
First and last name of mother
Age
Mother's date of birth
Theorical date of beginning of pregnancy
Childbirth date
Other: Prenatal Diagnostic Center of Toulouse University Hospital data
Data collected are :
First and last name of the mother
Mother's birth date
Mother Obstetric history
Course of pregnancy
Drug exposure (name, decision period)
Medical termination of pregnancy (date, cause ...)
Malformations (description, test results, gender of the child,
Weight, height and head circumference, American Pediatric Gross Assessment Record, neonatal pathology).
Other: Mother and child protection data collection
Date collected are :
Name and surname of Mother
Date of birth of the mother
Obstetric history of the mother (the first certificate to 8 days)
Course of pregnancy (1st certificate to 8 days)
Birth data (1 certificate to 8 days)
Child gender,
Age of the child at the time of the review,
Weight, height and head circumference of the child
American Pediatric Gross Assessment Record (1 certificate to 8 days)
Neonatal diseases (1 certificate to 8 days)
Birth defects (1 certificate to 8 days)
Death (age at death)
History (certificates at 9 and 24 months)
Current diseases (certificates at 9 and 24 months)
Psychomotor development (certificates at 9 and 24 months).
Date of drugs issue
Amount of drug issued
Type of feeding (1 certificate to 8 days)
Other: Medicalisation Program of Information Systems data
Data collected are :
First and last name of the mother
Mother's birth date
History of abortions (date and cause)
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Outcome Measures
Primary Outcome Measures
- Evaluation of risk to drug exposition in utero as assessed by descriptive analysis of data gathered [Through the study completion, an average of 36 months]
Analysis of all data collected from the four sources of information : Primary Health Insurance Fund Medicalisation Program of Information Systems Mother and child protection Prenatal Diagnostic Center of Toulouse University Hospital
Secondary Outcome Measures
- Assessment of risk associated with non prescription drugs during pregnancy as assessed by descriptive analysis of data gathered [Through the study completion, an average of 36 months]
Analysis of all data collected from the four sources of information : Primary Health Insurance Fund Medicalisation Program of Information Systems Mother and child protection Prenatal Diagnostic Center of Toulouse University Hospital
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women supported by the general scheme of the Primary Health Insurance Fund of the Haute-Garonne who gave birth or had a miscarriage between 1 January 2015 and 31 december 2017.
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Women not opposing that us to access to their data.
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Women for which at least one baby health certificate has been registered at the Mother and child protection, or the outcome of pregnancy was identified by prenatal diagnosis center or Medicalisation Program of Information Systems.
Exclusion Criteria:
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Women that refuses to give access to the data concerning them.
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Women for which no data on pregnancy outcome can be collected.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital of Toulouse | Toulouse | France | 31000 |
Sponsors and Collaborators
- University Hospital, Toulouse
Investigators
- Study Director: Christine Damase-Michel, PHD, University of Toulouse
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC31/16-7917