Evaluating medication risks in pregnant women
Evaluation of Drug's Risk in Pregnant Women
University Hospital, Toulouse · NCT02818842
This study is trying to see if taking certain medications during pregnancy can lead to birth defects or health issues in newborns.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Toulouse (other) |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT02818842 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the risks associated with medication use during pregnancy, focusing on potential birth defects and neonatal pathologies. Utilizing a comprehensive database called EFEMERIS, which has been collecting data since 2004, the study records information on medications taken by pregnant women in Haute-Garonne, along with pregnancy outcomes and newborn health. The database includes over 90,000 women and continues to enroll approximately 10,000 new participants each year to investigate the effects of various medications that have not been thoroughly evaluated in pregnant populations.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women in Haute-Garonne who are enrolled in the Primary Health Insurance Fund and have given birth or experienced a miscarriage between January 2015 and December 2017.
Not a fit: Patients who refuse access to their health data or for whom no pregnancy outcome data can be collected will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of medications during pregnancy, helping to inform better prescribing practices.
How similar studies have performed: Other studies have successfully utilized similar database approaches to evaluate medication risks in pregnant populations, indicating a promising methodology.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toulouse
- University Hospital of Toulouse — Toulouse, France (RECRUITING)
Study contacts
- Study coordinator: Christine Damase-Michel, PHD
- Email: christine.damase-michel@univ-tlse3.fr
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy, Database, Birth defects, Neonatal pathologies