Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 48 of 456 for:    Inherited Bleeding Disorder

Evaluation of Obstetrical and Neonatal Complications in Hereditary Haemorrhagic Telangiectasia (HHT) (CONCERTO)

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: NCT03691142
Recruitment Status : Not yet recruiting
First Posted : October 1, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 380 participants
Observational Model: Other
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
Women with Hereditary Haemorrhagic Telangiectasia
Women with Hereditary Haemorrhagic Telangiectasia with at least one full term pregnancy
Other: Questionnaire
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with Hereditary Haemorrhagic Telangiectasia and one or more past pregnancies.
Criteria

Inclusion Criteria:

  • Women ≥ 18 years.
  • Patients monitored for clinically confirmed Hereditary Haemorrhagic Telangiectasia (presence of at least three Curaçao criteria) and / or with molecular biology confirmation.
  • Patients with at least 1 full term pregnancy between 1960 and 2018.
  • Received information and no opposition to participate in the study.

Exclusion Criteria:

  • No full term pregnancies.
  • Refusal to participate in the study.

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): NCT03691142


Contacts
Layout table for location contacts
Contact: Sophie DUPUIS-GIROD, Dr 04 27 85 65 25 ext +33 sophie.dupuis-girod@chu-lyon.fr
Contact: Laura DELAGRANGE 04 27 85 65 27 ext +33 laura.delagrange@chu-lyon.fr

Locations
Layout table for location information
France
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    sophie.dupuis-girod@chu-lyon.fr   
Contact: Laura DELAGRANGE    04 27 85 65 27 ext +33    laura.delagrange@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon

Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03691142     History of Changes
Other Study ID Numbers: 69HCL18_0267
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Telangiectasis
Telangiectasia, Hereditary Hemorrhagic
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities