Pregnancy and Medically Assisted Conception in Rare Diseases

Recruiting

• Conditions: Sjogren Syndrome; Myositis; Vasculitis; Systemic Lupus Erythematosus; Spondyloarthritis; Antiphospholipid Syndrome; Rheumatoid Arthritis; Scleroderma; Mastocytosis; Psoriatic Arthritis

• Registration Number: NCT02450396
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-21
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-01
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
"good" obstetric outcome	35 week gestation until 1 year Post Partum	It's a composite outcome . A pregnancy with no severe maternal complication (by the Epimoms\* definition), live birth after 35 weeks' gestation, a birth weight \>10th percentile of the general population and no infections (maternal and infant) during pregnancy and first year of follow up, respectively

Secondary Outcome Measures

Name	Time	Method
Define the best therapeutic management strategies	2 years	About the organisation of care (analysis of the effect on outcome of the number of ultrasound examinations and clinician visits, and the systematic planning of delivery)
Conduct pharmacoepidemiologic studies	2 years	Analyse the frequency of exposure to various medications (immunosuppressors, biological therapy, corticosteroids) and their maternal and fetal consequences (e.g., infectious complications).
Analyse the frequency of exposure to various medications (immunosuppressors, biological therapy, corticosteroids) and their maternal and fetal consequences (e.g., infectious complications).	9 months	Within an existing collection with (1) samples taken during the first trimester of pregnancy to analyse markers that might predict subsequent obstetric complications (cytokines, growth factors, enzymes) (2) with cord blood samples (which will, in particular, enable immunological and pharmacological analyses).

Trial Locations

Locations (1)

Hôpital Cochin; 🇫🇷 Paris, France