Evaluation of Drug's Risk in Pregnant Women

Pregnancy Clinical Trial

— EFEMERIS  

Official title:

Evaluation of Drug's Risk in Pregnant Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02818842
• Other study ID #: RC31/16-7917
• Status: Recruiting
• Start date: January 2010
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Christine Damase-Michel, PHD
• Email: christine.damase-michel[@]univ-tlse3.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 women.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Women that refuses to give access to the data concerning them.

• Women for which no data on pregnancy outcome can be collected.

Related Conditions & MeSH terms

• Pregnancy

Intervention

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
• 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).
• 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)
• 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)

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

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/s0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through the study completion, an average of 36 months
Secondary	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	Through the study completion, an average of 36 months