Evaluation of Drug's Risk in Pregnant Women (EFEMERIS)

July 26, 2023 updated by: University Hospital, Toulouse
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through the study completion, an average of 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Study Director: Christine Damase-Michel, PHD, University of Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimated)

June 30, 2016

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RC31/16-7917

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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