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OpenTrials
Completed

NCT Number: NCT04253535

Risk of Recurrence of Cervical Artery Dissection During Pregnancy and Puerperium

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.

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Key information

Conditions

Cervical Artery Dissection

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital

Nantes, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaries

Other

Study on questionnaries

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2020
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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