Clinical trial NCT04253535: Risk of Recurrence of Cervical Artery Dissection During Pregnancy and Puerperium
Official title: A Prospective Study to Evaluate the Risk of Recurrence of Cervical Artery Dissection During Subsequent Pregnancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Artery Dissection
Keywords: Pregnancy
Puerperium Recurrence
Cervical artery dissection
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of CAD during pregnancy, childbirth or puerperium
timeFrame: Day 0
Secondary outcomes:
measure: To determine the absolute risk of recurrence of CAD in this population.
timeFrame: Day 0
measure: To assess obstetrical monitoring, way of delivery, and management of antithrombotics during further pregnancy.
timeFrame: Day 0
measure: To study the reasons of absence of pregnancy after a history of CAD
timeFrame: Day 0
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital
Study officials:
References: