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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

Tracking Information
First Submitted Date May 19, 2015
First Posted Date May 21, 2015
Last Update Posted Date June 24, 2016
Study Start Date June 2014
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2015)
"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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02450396 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 20, 2015)
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pregnancy and Medically Assisted Conception in Rare Diseases
Official Title Prospective Observational Study About Pregnancy and Medically Assisted Conception in Rare Diseases
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
serum, cord blood
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
Condition
  • 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
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 20, 2015)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Nathalie Costedoat-Chalumeau, PhD Costedoat-Chalumeau nathalie.costedoat@gmail.com
Contact: laurence Lecomte, PhD 158413545 ext 33 laurence.lecomte@cch.aphp.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02450396
Other Study ID Numbers 13.381bis
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators
  • SNFMI
  • SFR
  • CRAT
Investigators
Principal Investigator: Nathalie Costedoat-Chalumeau, PhD Hôpital Cochin
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date June 2016