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
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|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|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|
- Other: Questionnaire
Interview of women with a rare vascular disease through a phone questionnaire about severe and specific obstetrical complications during and after pregnancy.
- 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.
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
|Contact: Sophie DUPUIS-GIROD, Dr||04 27 85 65 25 ext +firstname.lastname@example.org|
|Contact: Amal AYADI ROBERT||04 27 85 66 03 ext +email@example.com|