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Evaluation of Drug's Risk in Pregnant Women

NCT02818842 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30000

Last updated 2023-07-27

No results posted yet for this study

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.

Conditions

  • Pregnancy

Interventions

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)

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Christine Damase-Michel, PHD · University of Toulouse

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02818842 on ClinicalTrials.gov