Comparison of MRI Versus Three Dimensional Ultrasound in the Diagnosis of Mullerian Duct Anomalies (MDA-3DUS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01393938
First received: May 27, 2011
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

Mullerian duct anomalies (MDAs) are relatively common disorders, with a prevalence estimated to be around 2% in the general population, and 6% to 7% in women with a history of recurrent pregnancy loss. Mullerian duct anomalies are associated with recurrent pregnancy loss, intra uterine growth retardation, and preterm labor and birth. The prevalence of preterm birth and pregnancy loss varies with the type of MDA. Patients can benefit from surgery or hysteroscopic interventions like metroplasty based on the type of MDA. Therefore, to optimize patient outcomes, accurate diagnosis and description of MDAs is essential.

Magnetic resonance imaging (MRI) is an excellent way of evaluating the uterus for MDAs. MRI, although costly, is less expensive than laparoscopy and hysteroscopy and is non-invasive. Pellerito et all evaluated 26 women with surgically proven MDAs and found that in 24 cases MRI was able to correctly diagnose the MDAs. Therefore MRI is generally considered as a reference standard for uterine evaluation. In a study comparing MRI and endovaginal Two-Dimensional Ultrasound (2DUS), MRI appeared to be more accurate than 2DUS with a sensitivity of 77%, specificity of 33%, and a positive predictive value of 83%.

Endovaginal Three-Dimensional Ultrasound (3DUS) is a relatively new technology that creates three-dimensional volumes from a series of two-dimensional images. This technique allows the user to acquire coronal or face-on-view of the uterus which is essential in evaluating the uterus for the presence of MDAs. Kupesic and Kurjak used 3DUS to evaluate 86 patients and found that it had sensitivity of 98.38%, specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 96% in the diagnosis of septate uteri [7]. Endovaginal 3DUS is less expensive, less invasive, and less-time consuming than hysteroscopy or MRI and appears to be a very promising technology for the evaluation of MDAs. 3DUS appears to be at least as accurate as MRI in the diagnosis of MDAs. In addition, 3DUS is less expensive than MRI and in some patients better tolerated. If validated using prospective studies, 3DUS has the potential to become the reference standard for the diagnosis of MDAs.


Condition Intervention
Mullerian Duct Anomaly
Other: Three-dimensional ultrasound

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of MRI Versus Three Dimensional Ultrasound in the Diagnosis of Mullerian Duct Anomalies

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Evaluation of 3D US and MRI in the diagnosis and assessment of patients with MDAs [ Time Frame: US and MRI within 1 month ] [ Designated as safety issue: No ]

    Currently the best way for imaging Müllerian Duct Anomalies (MDAs) is Magnetic Resonance Imaging (MRI). In addition, doctors use Two Dimensional Ultrasound (2D-US) to obtain additional pictures of these abnormalities.

    Three Dimensional Ultrasound is a new imaging method recently being used to assess these abnormalities. It works in exactly the same way as 2D-US, the only difference being a more up to date computer software, which helps obtain the better images.

    This study will assess the accuracy of MRI versus Three Dimensional Ultrasound in viewing and correctly diagnosing MDAs.



Estimated Enrollment: 50
Study Start Date: April 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Three-dimensional ultrasound
    Immediately following the standard of care 2D-US, for approximately 15 min.
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 16
  2. Patients with suspected Mullerian Duct Anomalies (history of recurrent miscarriage or history of primary or secondary infertility).
  3. Patients scheduled to undergo routine endovaginal or transabdominal Ultrasonography and pelvic MRI to evaluate possible MDAs

Exclusion Criteria:

  1. Age < 16
  2. General contraindications to MRI such as pacemaker etc.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393938

Contacts
Contact: Kartik Jhaveri, MD kartik.jhaveri@uhn.on.ca

Locations
Canada, Ontario
University Health Network-Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Kartik Jhaveri, MD       kartik.jhaveri@uhn.on.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Kartik Jhaveri, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Dr. Kartik Jhaveri, University Health Network
ClinicalTrials.gov Identifier: NCT01393938     History of Changes
Other Study ID Numbers: UHN090691BE2010
Study First Received: May 27, 2011
Last Updated: July 12, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Mullerian Duct Anomaly
3-dimensional Ultrasound
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 21, 2014