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

Completed

• Conditions: Hereditary Hemorrhagic Telangiectasia; Osler Rendu Disease
• Interventions: Other: Questionnaire

• Registration Number: NCT03691142
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-01
• Study Start: 2018-10-02
• Status Verified: 2019-10
• Primary Completion: 2019-10-02
• Study Completion: 2019-10-02
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 207

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with Hereditary Haemorrhagic Telangiectasia	Questionnaire	Women with Hereditary Haemorrhagic Telangiectasia with at least one full term pregnancy

Primary Outcome Measures

Name	Time	Method
Occurrence of complications during pregnancy	Interview time (about 15 minutes)	The questionnaire consists in collecting obstetric history (number of pregnancies, abortions), complications during pregnancy, delivery type and neonatal outcomes.

Trial Locations

Locations (1)

Centre de Référence pour la maladie de Rendu-Osler Service Génétique Clinique Bâtiment A1 - Hôpital Femme-Mère-Enfant - Hospices Civils de Lyon; 🇫🇷 Bron, France