Mullerian Duct Anomaly Clinical Trial
— MDA-3DUSOfficial title:
Comparison of MRI Versus Three Dimensional Ultrasound in the Diagnosis of Mullerian Duct Anomalies
| Verified date | January 2015 |
| Source | University Health Network, Toronto |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 16 |
| Est. completion date | February 2013 |
| Est. primary completion date | January 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 16 Years and older |
| Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Canada | University Health Network-Princess Margaret Hospital | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| University Health Network, Toronto |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of 3D US and MRI in the diagnosis and assessment of patients with MDAs | 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. |
US and MRI within 1 month | No |