Risk of Recurrence of Cervical Artery Dissection During Pregnancy and Puerperium

Cervical Artery Dissection Clinical Trial

Official title:

A Prospective Study to Evaluate the Risk of Recurrence of Cervical Artery Dissection During Subsequent Pregnancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04253535
• Other study ID #: RC19_0267
• Status: Completed
• Start date: February 14, 2020
• Est. completion date: June 15, 2020

Study information

• Verified date: December 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Cervical Artery Dissection
• Recurrence

Intervention

Other:
• questionnaries
Study on questionnaries

Locations

Country	Name	City	State
France	University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of CAD during pregnancy, childbirth or puerperium	This primary study endpoint will be evaluated by a questionnaire asked directly to participating women.	Day 0
Secondary	To determine the absolute risk of recurrence of CAD in this population.	This secondary endpoint will be evaluated by a questionnaire asked directly to participating women.	Day 0
Secondary	To assess obstetrical monitoring, way of delivery, and management of antithrombotics during further pregnancy.	This secondary endpoint will be evaluated by a questionnaire asked directly to participating women.	Day 0
Secondary	To study the reasons of absence of pregnancy after a history of CAD	This secondary endpoint will be evaluated by a questionnaire asked directly to participating women.	Day 0