Risk of Recurrence of Cervical Artery Dissection During Pregnancy and Puerperium

December 1, 2020 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2020

Primary Completion (Actual)

June 15, 2020

Study Completion (Actual)

June 15, 2020

Study Registration Dates

First Submitted

January 31, 2020

First Submitted That Met QC Criteria

February 3, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

December 2, 2020

Last Update Submitted That Met QC Criteria

December 1, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC19_0267

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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