Risk of Recurrence of Cervical Artery Dissection During Pregnancy and Puerperium

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04253535
• Collaborator: (none)
• Enrollment: 91
• Location: 1
• Actual Duration (Months): 4
• Patients Per Site Per Month: 22.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Artery Dissection	Other: questionnaries

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 Design

• Study Type: Observational
• Actual Enrollment: 91 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: A Prospective Study to Evaluate the Risk of Recurrence of Cervical Artery Dissection During Subsequent Pregnancies
• Actual Study Start Date: Feb 14, 2020
• Actual Primary Completion Date: Jun 15, 2020
• Actual Study Completion Date: Jun 15, 2020

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital	Nantes		France	44093

Sponsors and Collaborators

• Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT04253535
• Other Study ID Numbers: RC19_0267
• First Posted: Feb 5, 2020
• Last Update Posted: Dec 2, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nantes University Hospital: Pregnancy; Puerperium Recurrence; Cervical artery dissection
• Additional relevant MeSH terms: Aneurysm, Dissecting; Recurrence

Study Results

No Results Posted as of Dec 2, 2020