Pregnancy management in women with rare diseases
Prospective Observational Study About Pregnancy and Medically Assisted Conception in Rare Diseases
This study looks at how to better manage pregnancies in women with rare diseases like rheumatoid arthritis and lupus to ensure safer outcomes for both mothers and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT02450396 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on understanding the complexities of pregnancy in women with rare diseases, such as rheumatoid arthritis and systemic lupus erythematosus. It aims to address the lack of standardized management protocols for these pregnancies, which often involve high risks and complications. By forming an interdisciplinary research group, the study seeks to gather data on medication exposure and its effects on both mothers and children during pregnancy. The findings will help improve care and monitoring for these patients.
Who should consider this trial
Good fit: Ideal candidates include women of childbearing age diagnosed with a rare or systemic disease who are currently pregnant or undergoing medically assisted conception.
Not a fit: Patients who are not pregnant or do not have a rare or systemic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and outcomes for pregnant women with rare diseases.
How similar studies have performed: While there is limited data on similar studies, the interdisciplinary approach to managing pregnancy in rare diseases is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Woman with a rare and/or systemic disease * Pregnancy confirmed by a positive beta-HCG assay or an obstetric ultrasound OR medically assisted conception procedure * Patient agreed to participate Exclusion Criteria: * Adults under guardianship * People hospitalised without their consent and not protected by the law * Persons deprived of their liberty
Where this trial is running
Paris
- Hôpital Cochin — Paris, France (Recruiting)
Study contacts
- Principal investigator: Nathalie Costedoat-Chalumeau, PhD — Hôpital Cochin
- Study coordinator: Nathalie Costedoat-Chalumeau, PhD
- Email: nathalie.costedoat@gmail.com
- Phone: Costedoat-Chalumeau
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.