Evaluation of Obstetrical and Neonatal Complications in Hereditary Haemorrhagic Telangiectasia (HHT) (CONCERTO)
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|ClinicalTrials.gov Identifier: NCT03691142|
Recruitment Status : Not yet recruiting
First Posted : October 1, 2018
Last Update Posted : October 2, 2018
Hereditary Haemorrhagic Telangiectasia (HHT) is a rare inherited genetic disease of autosomal dominant inheritance with a prevalence of about 1/5000. It is manifested by haemorrhage, mucocutaneous telangiectasia and visceral arteriovenous malformations (AVMs) (lung, liver and nervous system).
Severe complications during pregnancy in HHT are rare but considered high risk. Intracranial or pulmonary haemorrhage, stroke and heart failure have been reported in some women with HHT during pregnancy. These complications occur most often in the second and third trimesters when maternal physiological changes such as peripheral vasodilatation and increased cardiac output are at their peak.
Previous retrospective studies were conducted with numbers ranging from 40 to 97 patients and highlighted the importance of early screening of complications and specific management.
The aim of this study is to describe, on a larger number of patients, the obstetric and neonatal complications in patients with HHT and followed in the French Reference Center for HHT.
|Condition or disease||Intervention/treatment|
|Osler Rendu Disease Hereditary Hemorrhagic Telangiectasia||Other: Questionnaire|
|Study Type :||Observational|
|Estimated Enrollment :||380 participants|
|Official Title:||A Retrospective Study of Obstetrical and Neonatal Complications in Hereditary Haemorrhagic Telangiectasia (HHT)|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
Women with Hereditary Haemorrhagic Telangiectasia
Women with Hereditary Haemorrhagic Telangiectasia with at least one full term pregnancy
Interview of women with Hereditary Haemorrhagic Telangiectasia (HHT) during a consultation in the Reference Center for HHT or through a phone questionnaire about obstetric history, complications during pregnancy, delivery and neonatal outcomes.
- Occurrence of complications during pregnancy [ Time Frame: Interview time (about 15 minutes) ]The questionnaire consists in collecting obstetric history (number of pregnancies, abortions), complications during pregnancy, delivery type and neonatal outcomes.
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): NCT03691142
|Contact: Sophie DUPUIS-GIROD, Dr||04 27 85 65 25 ext +email@example.com|
|Contact: Laura DELAGRANGE||04 27 85 65 27 ext +firstname.lastname@example.org|
|Centre de Référence pour la maladie de Rendu-Osler Service Génétique Clinique Bâtiment A1 - Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon||Not yet recruiting|
|Bron, France, 69677|
|Contact: Sophie DUPUIS-GIROD, Dr 04 27 85 65 25 ext +33 email@example.com|
|Contact: Laura DELAGRANGE 04 27 85 65 27 ext +33 firstname.lastname@example.org|