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| ID | Type | Description | Link |
|---|---|---|---|
| 13.381bis | Other Identifier | Other |
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Abandonment of the study project
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| Name | Class |
|---|---|
| SNFMI | UNKNOWN |
| SFR | UNKNOWN |
| CRAT | UNKNOWN |
| URC-CIC Paris Descartes Necker Cochin |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| "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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Conduct pharmacoepidemiologic studies |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie Costedoat-Chalumeau, PhD | Hôpital Cochin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cochin | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42049394 | Derived | Hornez M, Molto A, Leroy M, Banneville B, Belkhir R, Chauvet E, Couderc M, Dernis E, Devauchelle-Pensec V, Frazier A, Gossec L, Gervais E, Marotte H, Richez C, Sellam J, Seror R, Le Guern V, Guettrot-Imbert G, Costedoat-Chalumeau N, Flipo RM, Letarouilly JG. Impact of postpartum on patients with rheumatoid arthritis and spondyloarthritis: an ancillary analysis of the GR2 prospective cohort. RMD Open. 2026 Apr 28;12(2):e006593. doi: 10.1136/rmdopen-2025-006593. | |
| 39702994 |
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serum, cord blood
Analyse the frequency of exposure to various medications (immunosuppressors, biological therapy, corticosteroids) and their maternal and fetal consequences (e.g., infectious complications). |
| 2 years |
| 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 |
| Derived |
| Dernoncourt A, Guettrot-Imbert G, Sentilhes L, Besse MC, Molto A, Queyrel-Moranne V, Besnerais ML, Lazaro E, Tieulie N, Richez C, Hachulla E, Sarrot-Reynauld F, Leroux G, Orquevaux P, London J, Sailler L, Souchaud-Debouverie O, Smets P, Godeau B, Pannier E, Murarasu A, Berezne A, Goulenok T, Morel N, Mouthon L, Duhaut P, Guern VL, Costedoat-Chalumeau N; Gr2 Study Group. Safety of Fertility Treatments in Women With Systemic Lupus Erythematosus: Data From a Prospective Population-Based Study. BJOG. 2025 Apr;132(5):614-624. doi: 10.1111/1471-0528.18050. Epub 2024 Dec 19. |
| 38837707 | Derived | Alle G, Guettrot-Imbert G, Larosa M, Murarasu A, Lazaro E, Morel N, Orquevaux P, Sailler L, Queyrel V, Hachulla E, Sarrot Reynauld F, Perard L, Berezne A, Morati-Hafsaoui C, Chauvet E, Richez C, Goulenok T, London J, Molto A, Urbanski G, Le Besnerais M, Langlois V, Leroux G, Souchaud-Debouverie O, Roussin CL, Poindron V, Blanchet B, Pannier E, Sentilhes L, Mouthon L, Le Guern V, Costedoat-Chalumeau N; GR2 Study Group. Hydroxychloroquine levels in pregnancy and materno-fetal outcomes in systemic lupus erythematosus patients. Rheumatology (Oxford). 2025 Mar 1;64(3):1225-1233. doi: 10.1093/rheumatology/keae302. |
| 38261392 | Derived | Murarasu A, Guettrot-Imbert G, Le Guern V, Yelnik C, Queyrel V, Schleinitz N, Ferreira-Maldent N, Diot E, Urbanski G, Pannier E, Lazaro E, Souchaud-Debouverie O, Orquevaux P, Belhomme N, Morel N, Chauvet E, Maurier F, Le Besnerais M, Abisror N, Goulenok T, Sarrot-Reynauld F, Deroux A, Pasquier E, de Moreuil C, Bezanahary H, Perard L, Limal N, Langlois V, Calas A, Godeau B, Lavigne C, Hachulla E, Cohen F, Benhamou Y, Raffray L, de Menthon M, Tieulie N, Poindron V, Mouthon L, Larosa M, Elefant E, Sentilhes L, Molto A, Deneux-Tharaux C, Costedoat-Chalumeau N; GR2 Study Group. Characterisation of a high-risk profile for maternal thrombotic and severe haemorrhagic complications in pregnant women with antiphospholipid syndrome in France (GR2): a multicentre, prospective, observational study. Lancet Rheumatol. 2022 Dec;4(12):e842-e852. doi: 10.1016/S2665-9913(22)00308-3. Epub 2022 Nov 24. |
| 35015828 | Derived | Larosa M, Le Guern V, Guettrot-Imbert G, Morel N, Abisror N, Morati-Hafsaoui C, Orquevaux P, Diot E, Doria A, Sarrot-Reynauld F, Limal N, Queyrel V, Souchaud-Debouverie O, Sailler L, Le Besnerais M, Goulenok T, Molto A, Pannier-Metzger E, Sentilhes L, Mouthon L, Lazaro E, Costedoat-Chalumeau N; GR2 Group. Evaluation of lupus anticoagulant, damage, and remission as predictors of pregnancy complications in systemic lupus erythematosus: the French GR2 study. Rheumatology (Oxford). 2022 Aug 30;61(9):3657-3666. doi: 10.1093/rheumatology/keab943. |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D025241 | Spondylarthritis |
| D015535 | Arthritis, Psoriatic |
| D008180 | Lupus Erythematosus, Systemic |
| D016736 | Antiphospholipid Syndrome |
| D012859 | Sjogren's Syndrome |
| D045743 | Scleroderma, Diffuse |
| D009220 | Myositis |
| D014657 | Vasculitis |
| D008415 | Mastocytosis |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D025242 | Spondylarthropathies |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D012595 | Scleroderma, Systemic |
| D009135 | Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000090362 | Mast Cell Activation Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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