Clinical trial NCT02818842: Evaluation of Drug's Risk in Pregnant Women
Official title: Evaluation of Drug's Risk in Pregnant Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy
Keywords: Database
Birth defects
Neonatal pathologies
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 30000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of risk to drug exposition in utero as assessed by descriptive analysis of data gathered
timeFrame: Through the study completion, an average of 36 months
Secondary outcomes:
measure: Assessment of risk associated with non prescription drugs during pregnancy as assessed by descriptive analysis of data gathered
timeFrame: Through the study completion, an average of 36 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University of Toulouse
name: Christine Damase-Michel, PHD
role: STUDY_DIRECTOR
References:
citation: 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.