Clinical trial · Observational
Pregnancy and Medically Assisted Conception in Rare Diseases
Prospective Observational Study About Pregnancy and Medically Assisted Conception in Rare Diseases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Abandonment of the study project
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antiphospholipid Syndrome | — | UNRESOLVED | — |
| Mastocytosis | Mastocytosis | ONTOLOGY_EXACT | 0.98 |
| Myositis | — | UNRESOLVED | — |
| Psoriatic Arthritis | — | UNRESOLVED | — |
| Rheumatoid Arthritis | — | UNRESOLVED | — |
| Scleroderma | — | UNRESOLVED | — |
| Sjogren Syndrome | — | UNRESOLVED | — |
| Spondyloarthritis | — | UNRESOLVED | — |
| Systemic Lupus Erythematosus | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- "good" obstetric outcome
- timeFrame
- 35 week gestation until 1 year Post Partum
- description
- 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 outcomes (3)
- measure
- Define the best therapeutic management strategies
- timeFrame
- 2 years
- description
- 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)
- measure
- Conduct pharmacoepidemiologic studies
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (5)
- DERIVEDHornez 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. PMID 42049394
- DERIVEDDernoncourt 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. PMID 39702994
- DERIVEDAlle 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. PMID 38837707
- DERIVEDMurarasu 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.