Evaluation of Drug's Risk in Pregnant Women

NCT02818842 | Unknown

• 1 other identifier: RC31/16-7917
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Database; Birth defects; Neonatal pathologies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

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; Other: Prenatal Diagnostic Center of Toulouse University Hospital data; Other: Mother and child protection data collection; Other: Medicalisation Program of Information Systems data

Interventions

Primary Health Insurance Fund data OTHER

Data collected are: * First and last name of mother * Age * Mother's date of birth * Theorical date of beginning of pregnancy * Childbirth date

Pregnant Women

Prenatal Diagnostic Center of Toulouse University Hospital data OTHER

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).

Pregnant Women

Mother and child protection data collection OTHER

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)

Pregnant Women

Medicalisation Program of Information Systems data OTHER

Data collected are : * First and last name of the mother * Mother's birth date * History of abortions (date and cause)

Pregnant Women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Women that refuses to give access to the data concerning them.
• Women for which no data on pregnancy outcome can be collected.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31000, France

RECRUITING

Related 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/s00406-018-0906-2. Epub 2018 May 26.

  PMID: 29804133 RESULT

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Christine Damase-Michel, PHD

  University of Toulouse

  STUDY DIRECTOR

Central Study Contacts

Christine Damase-Michel, PHD

CONTACT

christine.damase-michel@univ-tlse3.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 30, 2016
• Study Start: January 1, 2010
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

FR (1)