Pregnancy and Medically Assisted Conception in Rare Diseases

Rheumatoid Arthritis Clinical Trial

— EGR2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02450396
• Other study ID #: 13.381bis
• Status: Recruiting
• Start date: June 2014
• Est. completion date: December 2025

Study information

• Verified date: October 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Nathalie Costedoat-Chalumeau, PhD
• Phone: Costedoat-Chalumeau
• Email: nathalie.costedoat[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Arthritis
• Arthritis, Psoriatic
• Lupus Erythematosus, Systemic
• Mastocytosis
• Myositis
• Psoriatic Arthritis
• Rare Diseases
• Rheumatoid Arthritis
• Scleroderma
• Sjogren Syndrome
• Sjogren's Syndrome
• Spondyloarthritis
• Syndrome
• Systemic Lupus Erythematosus
• Various Autoimmune and/or Systemic and/or Rare Diseases
• Vasculitis

Locations

Country	Name	City	State
France	Hôpital Cochin	Paris

Sponsors (4)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	CRAT, SFR, SNFMI

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"good" obstetric outcome	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	35 week gestation until 1 year Post Partum
Secondary	Define the best therapeutic management strategies	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)	2 years
Secondary	Conduct pharmacoepidemiologic studies	Analyse the frequency of exposure to various medications (immunosuppressors, biological therapy, corticosteroids) and their maternal and fetal consequences (e.g., infectious complications).	2 years
Secondary	Analyse the frequency of exposure to various medications (immunosuppressors, biological therapy, corticosteroids) and their maternal and fetal consequences (e.g., infectious complications).	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).	9 months