Pregnancy and Medically Assisted Conception in Rare Diseases (EGR2)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Myositis; Mastocytosis; Antiphospholipid Syndrome; Sjogren Syndrome; Various Autoimmune and/or Systemic and/or Rare Diseases; Scleroderma; Spondyloarthritis; Vasculitis; Psoriatic Arthritis; Systemic Lupus Erythematosus; Rheumatoid Arthritis

Study type: Observational

Funder types: Other

Identifiers

NCT02450396

13.381bis

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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