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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2022 |
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Main ID: |
NCT02450396 |
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Date of registration:
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19/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pregnancy and Medically Assisted Conception in Rare Diseases
EGR2 |
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Scientific title:
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Prospective Observational Study About Pregnancy and Medically Assisted Conception in Rare Diseases |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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5000 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02450396 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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France
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Contacts
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Name:
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Nathalie Costedoat-Chalumeau, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hôpital Cochin |
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Name:
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Nathalie Costedoat-Chalumeau, PhD |
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Address:
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Telephone:
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Costedoat-Chalumeau |
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Email:
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nathalie.costedoat@gmail.com |
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Affiliation:
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Name:
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nathalie Costedoat-Chalumeau, PhD |
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Address:
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Telephone:
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+33 1 58 41 32 43 |
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Email:
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nathalie.costedoat@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Psoriatic Arthritis
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Sjogren Syndrome
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Mastocytosis
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Rheumatoid Arthritis
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Scleroderma
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Antiphospholipid Syndrome
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Myositis
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Spondyloarthritis
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Systemic Lupus Erythematosus
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Vasculitis
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Various Autoimmune and/or Systemic and/or Rare Diseases
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Primary Outcome(s)
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"good" obstetric outcome
[Time Frame: 35 week gestation until 1 year Post Partum]
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Secondary Outcome(s)
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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]
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Define the best therapeutic management strategies
[Time Frame: 2 years]
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Conduct pharmacoepidemiologic studies
[Time Frame: 2 years]
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Secondary ID(s)
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13.381bis
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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