Risk of Recurrence of Cervical Artery Dissection During Pregnancy and Puerperium

Completed

• Conditions: Cervical Artery Dissection

• Registration Number: NCT04253535
• Lead Sponsor: Nantes University Hospital

Brief Summary

Cervical artery dissection (CAD) accounts for about 2% of all strokes, and is a major cause of stroke in young people (about 15%). Many cases of CAD during pregnancy and puerperium have been described, suggesting that pregnancy and puerperium may be potential risk factors for CAD. The purpose of this study is to determine whether pregnancy and puerperium are also recurrence risk factors for CAD.

Detailed Description

In this study, all women of childbearing age who had had a CAD between 2005 and 2017 are selected. Women are identified using the ICD10 diagnostic coding system. In addition, a text search with key words ("cervical or carotid or vertebral dissection") has been created in a data warehouse of the University Hospital of Nantes.

To determine the recurrence of CAD during pregnancy and puerperium, the participating women will be asked to answer to a questionnaire, by phone or mail. The questionnaire will be conducted by the same investigator, an experienced neurologist. Information about recurrence of CAD, number of pregnancies before and after the event will be recorded, as well as, the site of obstetrical monitoring, way of delivery, and management of antithrombotics, in case of further pregnancy. In case of no further pregnancy after the dissection, the reason will be explored.

Study Timeline

• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-05
• Study Start: 2020-02-14
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-15
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 91

Inclusion Criteria

• Extracranial carotid or vertebral dissection
• Symptomatic dissection (with symptom onset within the last four weeks)
• Spontaneous dissection
• Imaging evidence of dissection on MRI/MRA, CTA or ultrasound.

Exclusion Criteria

• Minors or adults under guardianship
• Intracranial artery dissection
• Traumatic or iatrogenic dissection
• Patient refusal to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of CAD during pregnancy, childbirth or puerperium	Day 0	This primary study endpoint will be evaluated by a questionnaire asked directly to participating women.

Secondary Outcome Measures

Name	Time	Method
To determine the absolute risk of recurrence of CAD in this population.	Day 0	This secondary endpoint will be evaluated by a questionnaire asked directly to participating women.
To assess obstetrical monitoring, way of delivery, and management of antithrombotics during further pregnancy.	Day 0	This secondary endpoint will be evaluated by a questionnaire asked directly to participating women.
To study the reasons of absence of pregnancy after a history of CAD	Day 0	This secondary endpoint will be evaluated by a questionnaire asked directly to participating women.

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Nantes, France