Mullerian Duct Anomaly Clinical Trial
Official title:
Comparison of MRI Versus Three Dimensional Ultrasound in the Diagnosis of Mullerian Duct Anomalies
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic