Non-contrast 3D MR Angiography for Assessment of the Thoracic Aorta in Pregnancy

November 8, 2016 updated by: William E Moody, University Hospital Birmingham NHS Foundation Trust

Native High-resolution 3D SSFP MR Angiography for Assessment of the Thoracic Aorta in Pregnant Subjects With Familial Aortopathies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant subjects in mid-trimester with familial aortopathy

Description

Inclusion Criteria:

  • Any pregnant subject with a history of familial aortopathy

Exclusion Criteria:

  • None

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gestation at delivery
Time Frame: 40 weeks
40 weeks
Completion of non-contrast 3D MRA aorta
Time Frame: 40 weeks
40 weeks

Collaborators and Investigators

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

Sponsor

University Hospital Birmingham NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

January 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

June 3, 2016

First Posted (Estimate)

June 8, 2016

Study Record Updates

Last Update Posted (Estimate)

November 10, 2016

Last Update Submitted That Met QC Criteria

November 8, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • RRK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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Locations

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