Informations générales (source: ClinicalTrials.gov)
Prospective Observational Study About Pregnancy and Medically Assisted Conception in Rare Diseases
Observational
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juin 2014
décembre 2025
15 septembre 2025
Rare diseases frequently affect women of childbearing age. Pregnancy in these women has
become less rare, but remains associated with high levels of complications. One obstacle
to their optimal management during pregnancy is that there are no prospective studies of
pregnancy during rare diseases and several connective tissue diseases. As a consequence,
the management of these pregnancies is non-standardised in terms of treatment, monitoring
(frequency of consultations, laboratory tests and ultrasound), and organisation of care.
Moreover, although these women (all diseases combined) are frequently exposed to
medications potentially incompatible with pregnancy, little is known about the frequency
of these exposures and especially their consequences to mother and child.
For these reasons, researchers and clinicians from different specialties created an
interdisciplinary research group on pregnancy and rare diseases (GR2), intended to
improve the management of these patients' pregnancies. Using a single computer server,
the investigators plan to set up a large prospective study of pregnancies in patients
with rare diseases: various forms of myositis, lupus, antiphospholipid syndrome, Sjogren
syndrome, scleroderma, and inflammatory rheumatic diseases. The investigators objective
is to analyse the complications of pregnancies in women with rare diseases and then to
improve their management and their quality of life.
Etablissements
Critères
Femme
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
- 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
- Adults under guardianship
- People hospitalised without their consent and not protected by the law
- Persons deprived of their liberty