Clinical trial NCT01393938: Comparison of MRI Versus Three Dimensional Ultrasound in the Diagnosis of Mullerian Duct Anomalies
Official title: Comparison of MRI Versus Three Dimensional Ultrasound in the Diagnosis of Mullerian Duct Anomalies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mullerian Duct Anomaly
Keywords: Mullerian Duct Anomaly
3-dimensional Ultrasound
Magnetic Resonance Imaging
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 16
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Evaluation of 3D US and MRI in the diagnosis and assessment of patients with MDAs
timeFrame: US and MRI within 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network-Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Kartik Jhaveri, MD
role: PRINCIPAL_INVESTIGATOR
References: