PregnancyEFEMERISNCT02818842
Evaluation of Drug's Risk in Pregnant Women
An observational study of Pregnancy, run by University Hospital, Toulouse at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Primary Health Insurance Fund data, Prenatal Diagnostic Center of Toulouse University Hospital data and Mother and child protection data collection
- How many people
- 30,000 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
- Women not opposing that us to access to their data.
- 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.
Who cannot join
- Women that refuses to give access to the data concerning them.
- Women for which no data on pregnancy outcome can be collected.
Trial locations and contacts
1 site in 1 country.
Christine Damase-Michel, PHD contact
France1 site, 1 recruiting
- Recruiting
University Hospital of Toulouse
Toulouse, 31000
Christine Damase-Michel, christine.damase-michel@univ-tlse3.fr
About this study
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- 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
- Keywords
- Database, Birth defects, Neonatal pathologies
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Health Insurance Fund dataOther
Data collected are:
- First and last name of mother
- Age
- Mother's date of birth
- Theorical date of beginning of pregnancy
- Childbirth date
Prenatal Diagnostic Center of Toulouse University Hospital dataOther
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).
Mother and child protection data collectionOther
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)
Medicalisation Program of Information Systems dataOther
Data collected are :
- First and last name of the mother
- Mother's birth date
- History of abortions (date and cause)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Primary Health Insurance Fund data; Other: Prenatal Diagnostic Center of Toulouse University Hospital data; Other: Mother and child protection data collection; Other: Medicalisation Program of Information Systems data |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 :
- Primary Health Insurance Fund
- Medicalisation Program of Information Systems
- Mother and child protection
- Prenatal Diagnostic Center of Toulouse University Hospital
Measured: Through the study completion, an average of 36 months
Secondary outcomes (1)
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 :
- Primary Health Insurance Fund
- Medicalisation Program of Information Systems
- Mother and child protection
- Prenatal Diagnostic Center of Toulouse University Hospital
Measured: Through the study completion, an average of 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startJan 2010
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Damase-Michel, PHD, Study director, University of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818842
- Sponsor's protocol ID
- RC31/16-7917
- Acronym
- EFEMERIS
- Status last verified
- Jul 2023
- First submitted
- 23 Jun 2016
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29804133
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Drug's Risk in Pregnant Women
- ClinicalTrials.gov ID
- NCT02818842
- Acronym / sponsor ID
- EFEMERIS / RC31/16-7917
- Conditions
- Pregnancy
- Keywords
- Database, Birth defects, Neonatal pathologies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | Other: Primary Health Insurance Fund data, Other: Prenatal Diagnostic Center of Toulouse University Hospital data, Other: Mother and child protection data collection, Other: Medicalisation Program of Information Systems dataMedical 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
- Women not opposing that us to access to their data.
- 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.
Key exclusion criteria (2 listed)
- Women that refuses to give access to the data concerning them.
- Women for which no data on pregnancy outcome can be collected.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Health Insurance Fund dataData collected are: * First and last name of mother * Age * Mother's date of birth * Theorical date of beginning of pregnancy * Childbirth date | Other | Pregnant Women |
| Prenatal Diagnostic Center of Toulouse University Hospital dataData 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 | Pregnant Women |
| Mother and child protection data collectionDate 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 | Pregnant Women |
| Medicalisation Program of Information Systems dataData collected are : * First and last name of the mother * Mother's birth date * History of abortions (date and cause) | Other | Pregnant Women |
Primary outcome
Evaluation of risk to drug exposition in utero as assessed by descriptive analysis of data gathered
Time frame: 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
1 secondary outcome
Assessment of risk associated with non prescription drugs during pregnancy as assessed by descriptive analysis of data gathered
Time frame: Through the study completion, an average of 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Results publication: PubMed 29804133Hurault-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Damase-Michel, PHD contact
Christine Damase-Michel, PHD study director
University of Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Damase-Michel, PHD (christine.damase-michel@univ-tlse3.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of risk to drug exposition in utero as assessed by descriptive analysis of data gathered (time frame: Through the study completion, an average of 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02818842, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.