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Pregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study (COGRare5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04194619
Recruitment Status : Not yet recruiting
First Posted : December 11, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

There are no prospective studies of pregnancies for the diseases studied here in (Heredity Hemorrhagic Telangiectasia, Marfan syndrome, primary lower limb lymphedema, superficial arteriovenous malformations, and cerebro-spinal arteriovenous malformations) although complications of these can present life-threatening health problems for the mother and her baby.

The purpose of this National prospective study is to obtain greater insight into obstetrical complications associated with rare maternal vascular genetic disorders in order to improve prevention and to reduce risk of death.

In this context, experts and patient associations consider that there is a need to make real progress in the formulation of recommendations based on scientific data.


Condition or disease Intervention/treatment
Vascular Anomaly Osler Rendu Disease Marfan Syndrome Lymphedema Primary Arteriovenous Malformations Cerebrospinal; Disorder Other: Questionnaire

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A National Prospective Cohort for Pregnancies in Patients With Rare Vascular Anomalies: COGRare5 Study
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2026



Intervention Details:
  • Other: Questionnaire
    Interview of women with a rare vascular disease through a phone questionnaire about severe and specific obstetrical complications during and after pregnancy.


Primary Outcome Measures :
  1. Occurrence of obstetrical complications among patients with rare vascular anomalies. [ Time Frame: Maximum 21 months ]

    The primary effectiveness endpoint is the occurrence of specific and serious obstetrical complications during and after the pregnancy period among patients with rare vascular anomalies.

    The questionnaire consists in collecting obstetric complications (interview time is about 15 minutes) every 3 months during and after pregnancy.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study describes severe and specific obstetrical complications during and after pregnancy (until 12 months postpartum) for the following pathologies: heredity hemorrhagic telangiectasia, marfan syndrome, primary lower limb lymphedema, superficial arteriovenous malformations or even cerebro-spinal arteriovenous malformations.
Criteria

Inclusion Criteria:

  • Women aged ≥ 18 years and ≤45 years at the time of inclusion
  • Pregnant and/or having given birth less than 1 month (≤ 30 days)
  • Clinically and/or radiological and/or molecular biology diagnosis of a rare vascular disease before or during pregnancy or one month after delivery.
  • Having been informed of all pertinent aspects of the study and provided oral non-opposition.

Exclusion Criteria:

  • Any person not fulfilling the inclusion criteria or refusing to take part in the study.
  • Major under legal protection

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): NCT04194619


Contacts
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Contact: Sophie DUPUIS-GIROD, Dr 04 27 85 65 25 ext +33 sophie.dupuis-girod@chu-lyon.fr
Contact: Amal AYADI ROBERT 04 27 85 66 03 ext +33 amal.ayadi@chu-lyon.fr

Locations
Show Show 32 study locations
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04194619    
Other Study ID Numbers: 69HCL19_0380
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marfan Syndrome
Arachnodactyly
Central Nervous System Diseases
Arteriovenous Malformations
Vascular Malformations
Telangiectasia, Hereditary Hemorrhagic
Lymphedema
Congenital Abnormalities
Lymphatic Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Heart Defects, Congenital
Heart Diseases
Abnormalities, Multiple
Genetic Diseases, Inborn
Connective Tissue Diseases
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Hemostatic Disorders
Telangiectasis
Hemorrhagic Disorders
Hematologic Diseases
Nervous System Diseases