EGR2: Pregnancy and Medically Assisted Conception in Rare Diseases

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT02450396

Collaborator

SNFMI (Other), SFR (Other), CRAT (Other)

5,000

Enrollment

Location

138

Anticipated Duration (Months)

36.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Spondyloarthritis Psoriatic Arthritis Systemic Lupus Erythematosus Antiphospholipid Syndrome Sjogren Syndrome Scleroderma Myositis Vasculitis Mastocytosis Various Autoimmune and/or Systemic and/or Rare Diseases

Study Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Observational Study About Pregnancy and Medically Assisted Conception in Rare Diseases

Actual Study Start Date :

Jun 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Outcome Measures

Primary Outcome Measures

"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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts 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