NCT02793570

Brief Summary

Introduction: Native magnetic resonance angiography (MRA) is recommended to assess the thoracic aorta during pregnancy, avoiding the risks of ionising radiation and contrast agent administration. This guidance is however, based only on consensus opinion supported by limited case reports (level of evidence C). Aim: To evaluate the feasibility of performing native 3D steady-state free-precession (SSFP) MRA in pregnant subjects with inherited aortopathy to guide timing and mode of delivery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

June 3, 2016

Last Update Submit

November 8, 2016

Conditions

Magnetic Resonance ImagingPregnancy

Outcome Measures

Primary Outcomes (2)

  • Gestation at delivery

    40 weeks

  • Completion of non-contrast 3D MRA aorta

    40 weeks

Interventions

observationalOTHER

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant subjects in mid-trimester with familial aortopathy

You may qualify if:

  • Any pregnant subject with a history of familial aortopathy

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QEHB

Birmingham, United Kingdom

Location

Related Links

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SpR Cardiology

Study Record Dates

First Submitted

June 3, 2016

First Posted

June 8, 2016

Study Start

January 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 10, 2016

Record last verified: 2016-11

Locations

GB(1)