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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
Sponsor:
Collaborators:
SNFMI
SFR
CRAT
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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
Observational Model: Cohort
Time Perspective: Prospective
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





Primary Outcome Measures :
  1. "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


Secondary Outcome Measures :
  1. 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)

  2. 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).

  3. 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
serum, cord blood


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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
Study Population
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
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Nathalie Costedoat-Chalumeau, PhD Costedoat-Chalumeau nathalie.costedoat@gmail.com
Contact: laurence Lecomte, PhD 158413545 ext 33 laurence.lecomte@cch.aphp.fr

Locations
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   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
SNFMI
SFR
CRAT
Investigators
Principal Investigator: Nathalie Costedoat-Chalumeau, PhD Hôpital Cochin

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02450396     History of Changes
Other Study ID Numbers: 13.381bis
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Rare diseases
pregnancy
pregnancy,

Additional relevant MeSH terms:
Syndrome
Arthritis
Arthritis, Rheumatoid
Lupus Erythematosus, Systemic
Arthritis, Psoriatic
Vasculitis
Rare Diseases
Sjogren's Syndrome
Spondylarthritis
Mastocytosis
Myositis
Antiphospholipid Syndrome
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthropathies
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Vascular Diseases
Cardiovascular Diseases
Disease Attributes