Pregnancy and Medically Assisted Conception in Rare Diseases (EGR2)
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|ClinicalTrials.gov Identifier: NCT02450396|
Recruitment Status : Recruiting
First Posted : May 21, 2015
Last Update Posted : June 24, 2016
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|
|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 Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Prospective Observational Study About Pregnancy and Medically Assisted Conception in Rare Diseases|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
- "good" obstetric outcome [ Time Frame: 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
- Define the best therapeutic management strategies [ Time Frame: 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 [ Time Frame: 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). [ Time Frame: 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).
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450396
|Contact: Nathalie Costedoat-Chalumeau, PhD||Costedoat-Chalumeaufirstname.lastname@example.org|
|Contact: laurence Lecomte, PhD||158413545 ext email@example.com|
|Paris, France, 75014|
|Contact: nathalie Costedoat-Chalumeau, PhD +33 1 58 41 32 43 firstname.lastname@example.org|
|Contact: laurence Lecomte, PhD 158413545 ext +33 email@example.com|
|Principal Investigator:||Nathalie Costedoat-Chalumeau, PhD||Hôpital Cochin|