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Pregnancy and Medically Assisted Conception in Rare Diseases

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02450396
Acronym
EGR2
Enrollment
0
Registered
2015-05-21
Start date
2015-06-01
Completion date
2025-12-01
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Rare diseases, pregnancy, pregnancy,

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
SNFMI
CollaboratorUNKNOWN
SFR
CollaboratorUNKNOWN
CRAT
CollaboratorUNKNOWN
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
"good" obstetric outcome35 week gestation until 1 year Post PartumIt'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

MeasureTime frameDescription
Define the best therapeutic management strategies2 yearsAbout 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 studies2 yearsAnalyse 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 monthsWithin 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).

Countries

France

Contacts

PRINCIPAL_INVESTIGATORNathalie Costedoat-Chalumeau, PhD

Hôpital Cochin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026