Evaluation of Drug's Risk in Pregnant Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Primary Health Insurance Fund data

Intervention Type OTHER

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

Intervention Type 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).

Mother and child protection data collection

Intervention Type 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)

Medicalisation Program of Information Systems data

Intervention Type OTHER

Data collected are :

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

Interventions

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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

Intervention Type 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).

Intervention Type 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)

Intervention Type 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)

Intervention Type OTHER

Eligibility Criteria

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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.