Pregnancy and Medically Assisted Conception in Rare Diseases (EGR2)
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| ClinicalTrials.gov Identifier: NCT02450396 |
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Recruitment Status :
Recruiting
First Posted : May 21, 2015
Last Update Posted : May 3, 2021
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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.
| Condition or disease |
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| 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 : | 5000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Prospective Observational Study About Pregnancy and Medically Assisted Conception in Rare Diseases |
| Actual Study Start Date : | June 2014 |
| Estimated Primary Completion Date : | June 2025 |
| Estimated Study Completion Date : | December 2025 |
- "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
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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-Chalumeau | nathalie.costedoat@gmail.com | |
| Contact: laurence Lecomte, PhD | 158413545 ext 33 | laurence.lecomte@cch.aphp.fr |
| France | |
| Hôpital Cochin | Recruiting |
| Paris, France, 75014 | |
| Contact: nathalie Costedoat-Chalumeau, PhD +33 1 58 41 32 43 nathalie.costedoat@gmail.com | |
| Contact: laurence Lecomte, PhD 158413545 ext +33 laurence.lecomte@aphp.fr | |
| Principal Investigator: | Nathalie Costedoat-Chalumeau, PhD | Hôpital Cochin |
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT02450396 |
| Other Study ID Numbers: |
13.381bis |
| First Posted: | May 21, 2015 Key Record Dates |
| Last Update Posted: | May 3, 2021 |
| Last Verified: | April 2021 |
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Rare diseases pregnancy pregnancy, |
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Mastocytosis Arthritis Arthritis, Psoriatic Sjogren's Syndrome Myositis Vasculitis Lupus Erythematosus, Systemic Antiphospholipid Syndrome Syndrome Rare Diseases Disease Pathologic Processes Joint Diseases Musculoskeletal Diseases Arthritis, Rheumatoid |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases Xerostomia Salivary Gland Diseases Mouth Diseases |