Diagnostic Accuracy of 3D/4D Transvaginal Ultrasound Compared With MRI for Müllerian Uterine Anomalies: A Prospective Study Using Hysteroscopic Confirmation for Septate Uterus

doi:10.21203/rs.3.rs-8231443/v1

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Diagnostic Accuracy of 3D/4D Transvaginal Ultrasound Compared With MRI for Müllerian Uterine Anomalies: A Prospective Study Using Hysteroscopic Confirmation for Septate Uterus

https://doi.org/10.21203/rs.3.rs-8231443/v1

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Objective:
To compare the diagnostic accuracy and concordance of three-dimensional/four-dimensional (3D/4D) ultrasonography and magnetic resonance imaging (MRI) in detecting Müllerian duct anomalies (MDAs) and to evaluate their impact on surgical decision-making.

Methods:
This prospective observational study included 32 patients who presented to the infertility or gynecology outpatient clinics at Gazi University Hospital between November 2016 and November 2017. All patients underwent both 3D/4D transvaginal ultrasonography (Voluson E6, GE Healthcare) and pelvic MRI (3T Verio, Siemens). Diagnoses were classified according to the American Society of Reproductive Medicine (ASRM, 1988) criteria. Concordance between the two imaging modalities was evaluated using the kappa (κ) statistic.

Results:
Of the 32 enrolled patients, 25 completed both imaging studies. Overall concordance between 3D/4D ultrasonography and MRI was 40% (κ = 0.266, p < 0.001), indicating low-to-moderate agreement. The most common diagnosis with 3D/4D ultrasonography was septate uterus (56%), compared with 20% by MRI. Among 13 patients who underwent surgery, 12 were correctly diagnosed as having septate uterus by 3D/4D ultrasonography (positive predictive value, 92.3%), while MRI correctly identified four (30.8%). Surgical decisions were based on 3D/4D ultrasonography in 69.2% of discordant cases and on MRI in 30.8%.

Conclusion:
Although MRI remains the reference standard for evaluating MDAs, 3D/4D ultrasonography demonstrated strong clinical value in guiding surgical management and offered advantages of accessibility, real-time assessment, and lower cost. We recommend that 3D/4D ultrasonography be performed by the operating gynecologist prior to surgical planning. Larger randomized studies are warranted to validate these findings.

Congenital uterine malformations arise from incomplete fusion, resorption, or development of the Müllerian ducts. The prevalence of Müllerian duct anomalies (MDAs) in the general population is approximately 4%, increasing to 6–7% among women with infertility or recurrent pregnancy loss. Accurate diagnosis is essential because MDAs are associated with adverse reproductive outcomes, including infertility, miscarriage, and preterm delivery [1].

Historically, hysterosalpingography (HSG) was the primary diagnostic tool, but its diagnostic accuracy is limited to about 55% and it exposes patients to radiation and potential infection [2]. While combined hysteroscopy and laparoscopy remain the gold standard for definitive diagnosis, their invasive nature and cost limit widespread use [7]. Therefore, non-invasive imaging modalities have gained importance [3].

Magnetic resonance imaging (MRI) has been shown to provide excellent anatomical detail and high diagnostic accuracy—reported sensitivity and specificity up to 100% in some studies [6,8]. However, its limited availability, cost, and requirement for radiologic interpretation restrict its routine use. In contrast, three-dimensional (3D) and four-dimensional (4D) ultrasonography are widely accessible, cost-effective, and allow real-time evaluation of uterine morphology, particularly the fundal contour, which is critical for differentiating septate from bicornuate uteri [5].

Previous studies have demonstrated high reproducibility and good correlation between 3D ultrasonography and surgical findings, suggesting that it may serve as a reliable, non-invasive alternative to MRI in selected patients [1, 5, 13, 21, 22]. The present study aims to compare the diagnostic concordance of 3D/4D ultrasonography and MRI in detecting Müllerian duct anomalies and to assess their respective influences on clinical decision-making regarding surgery.

Study Design and Participants

This was a prospective observational study conducted at the Department of Obstetrics and Gynecology, Gazi University School of Medicine (Ankara, Turkey), between November 2016 and November 2017. The study was approved by the Gazi University Ethics Committee (Approval No: GU-516/2015), and written informed consent was obtained from all participants.

Thirty-two women who presented to either the infertility or general gynecology outpatient clinics with suspected Müllerian duct anomalies (MDAs) were enrolled. Indications for imaging included infertility, recurrent pregnancy loss, abnormal uterine bleeding, or incidental findings on two-dimensional (2D) ultrasonography.

Inclusion and Exclusion Criteria

Inclusion criteria were reproductive-aged women with suspected uterine anomalies on clinical examination, 2D ultrasound, or hysterosalpingography (HSG).

Exclusion criteria were refusal to undergo MRI, pregnancy during the study, or failure to attend scheduled imaging appointments. Seven patients were excluded: two became pregnant, two were noncompliant with MRI, and three were lost to follow-up, leaving 25 patients for final analysis.

Imaging Protocols

3D/4D Ultrasonography:

All ultrasonographic examinations were performed by an experienced gynecologist using a Voluson E6 ultrasound system (GE Healthcare, Milwaukee, WI, USA) equipped with a 5–9 MHz transvaginal volume probe. 3D/4D reconstruction of the uterine cavity and fundal contour was performed using multiplanar and rendered imaging modes.

Magnetic Resonance Imaging (MRI):

MRI was performed using a 3-Tesla system (Verio, Siemens, Erlangen, Germany) with a phased-array multichannel body coil. Standard T1- and T2-weighted sequences were obtained in axial, sagittal, and coronal planes. No contrast enhancement was used. The menstrual phase was not standardized among participants.

Classification and Data Analysis

Uterine anomalies were classified according to the American Society for Reproductive Medicine (ASRM, 1988) criteria. MRI scans were interpreted by radiologists who were not blinded to ultrasonographic findings.

All data were analyzed using SPSS software (version 20.0, IBM Corp., Armonk, NY, USA). Concordance between 3D/4D ultrasonography and MRI was assessed using Cohen’s kappa (κ) statistic. Descriptive statistics were expressed as frequencies and percentages. A p-value < 0.05 was considered statistically significant.

Patient Characteristics

Of the 32 patients enrolled, 25 completed both imaging modalities and were included in the final analysis. Sixteen patients (50%) presented with infertility, three (9.3%) with a history of recurrent pregnancy loss, four (12.5%) with abnormal uterine bleeding, and seven (21.8%) were asymptomatic.

Imaging Findings

The distribution of uterine anomalies identified by 3D/4D ultrasonography and MRI is summarized in Table 1.

Diagnosis	3D/4D Ultrasonography (n = 25)	MRI (n = 25)	Surgically Confirmed (n = 13)
Septate uterus	14 (56%)	5 (20%)	13 (100%)
Arcuate uterus	4 (16%)	6 (24%)	0
Bicornuate uterus	3 (12%)	5 (20%)	0
Unicornuate uterus	1 (4%)	1 (4%)	0
Didelphys uterus	1 (4%)	0 (0%)	0
Rudimentary horn	2 (8%)	2 (8%)	0
No anomaly	0 (0%)	6 (24%)	0

3D/4D ultrasonography identified septate uterus as the most common anomaly (56%), whereas MRI reported a higher number of normal uterine findings (24%).

Concordance Between Modalities

Overall diagnostic concordance between 3D/4D ultrasonography and MRI was 40%, with a κ value of 0.266 (p < 0.001), indicating low-to-moderate agreement. Discrepancies were observed in 13 of 25 patients (52%), primarily between the diagnosis of septate and arcuate uterus.

Among the 13 patients who underwent surgery, 12 were confirmed to have septate uterus. 3D/4D ultrasonography correctly identified all 12 (positive predictive value, 92.3%), while MRI correctly diagnosed 4 (30.8%).

Surgical Decision-Making

Of the patients with discordant imaging results, surgical management was based on 3D/4D ultrasonography findings in 9 cases (69.2%) and on MRI findings in 4 cases (30.8%). The most significant diagnostic disagreement occurred in cases differentiating septate from arcuate uterus, particularly in women with infertility (n = 3, 60%) or recurrent pregnancy loss (n = 2, 40%).

This prospective study compared the diagnostic performance and concordance between 3D/4D ultrasonography and MRI in evaluating Müllerian duct anomalies (MDAs). We observed a 40% overall agreement (κ = 0.266, p < 0.001) between the two imaging modalities, indicating low-to-moderate concordance. The greatest discrepancy occurred in differentiating septate from arcuate uteri, a distinction that holds critical clinical implications for fertility and surgical management [7, 18].

Our findings support recent literature suggesting that 3D/4D ultrasonography may rival, and in some cases outperform, MRI for MDA diagnosis [12]. Earlier studies favored MRI for its superior soft-tissue contrast and multiplanar imaging capabilities [8]. However, advances in 3D ultrasonographic technology, coupled with operator expertise, have narrowed this diagnostic gap [13]. Several studies have reported strong agreement between 3D ultrasound and surgical findings, with sensitivity and specificity approaching 100% [15]. Recently, 3D ultrasound has been reported to be concordant with MRI in 2 retrospective studies. Cekdemir et al. found 26/27 (96.3%) of the patients were diagnosed accurately with 3D ultrasound, while 24/27 (88.9%) of the patients were diagnosed with MRI [22]. And Qin et al. showed that 27/29 (93,1%) of the patients were accurately diagnosed with 3D ultrasound, while 24/29 (82,8%) were diagnosed with MRI [21].

In the present study, 3D/4D ultrasonography correctly identified 92.3% of surgically confirmed septate uteri, compared with 30.8% for MRI. This high predictive accuracy may be attributed to the operator’s dual role as both the gynecologist and surgeon, allowing real-time correlation between clinical findings, patient history, and imaging interpretation. This integration of anatomical and functional information may explain why 3D/4D ultrasonography guided the majority (69.2%) of surgical decisions in discordant cases. A prospective study on 7 patients who underwent surgery after only 3D ultrasound diagnosis provided 100% accuracy [23]. Radiologists may not encounter Müllerian anomalies as often as experienced gynecologists do. When detailed patient history and physical examination are not accurately forwarded to radiologists, this may lower MRI diagnostic accuracy. Moreover, 3D/4D ultrasound should be actively used for patients suspected of Müllerian anomalies. A gynecologist will gain more experience as they apply 3D ultrasound, and the accuracy rate may even increase. study and the literature show that surgeries can be performed with only 3D ultrasound diagnosis. It will lower costs and shorten waiting times.

The most frequent diagnostic conflict occurred between septate and arcuate uterus. This difficulty is well recognized in the literature, as subtle differences in fundal indentation can lead to misclassification, particularly in MRI scans that lack dynamic uterine distension or patient-specific context [15]. Although arcuate uterus is generally considered a normal variant with favorable reproductive outcomes, some studies suggest that hysteroscopic correction may be beneficial in selected patients with recurrent pregnancy loss [9, 18, 19]. In our cohort, all three infertile patients with conflicting diagnoses had a history of reproductive failure, and two achieved pregnancy following surgical correction, supporting the potential benefit of 3D-guided decision-making.

Despite the small sample size, our results align with previous reports highlighting the practicality and cost-effectiveness of 3D/4D ultrasonography in routine gynecologic practice [13, 15].It provides real-time, high-resolution imaging of the uterine cavity and fundal contour, is widely available, and avoids the expense and limited accessibility of MRI. For these reasons, 3D/4D ultrasonography may serve as a reliable first-line modality in the diagnostic workup of MDAs, with MRI reserved for complex or inconclusive cases.

Limitations

This study has several limitations. The most notable is the relatively small sample size (n = 25), which limits the generalizability of the findings. Not all diagnoses were confirmed by surgical or hysteroscopic evaluation, reducing the ability to assess true diagnostic accuracy. The fact that ultrasonographic examinations were performed and interpreted by the same gynecologist who later operated on some of the patients may have introduced observer bias in favor of 3D/4D ultrasonography. Additionally, the study did not standardize imaging timing according to the menstrual cycle, which can influence uterine morphology and diagnostic clarity. Future multicenter studies with larger cohorts and blinded, independent assessments are warranted to validate these findings.

Three-dimensional/four-dimensional ultrasonography demonstrated strong diagnostic performance and clinical utility in evaluating Müllerian duct anomalies. Although MRI remains the reference standard, 3D/4D ultrasonography offers substantial advantages in accessibility, cost, and real-time interpretation by the treating gynecologist. Given its high predictive value and influence on surgical decision-making, we recommend incorporating 3D/4D ultrasonography as an initial diagnostic tool—particularly when performed by experienced gynecologists familiar with both imaging and operative management. Larger randomized controlled studies are required to confirm these results further and to establish standardized imaging criteria for uterine anomaly classification.

Ethical approval number: GU-516/2015 (Gazi University Ethical Committee)

Clinical trial number: Not applicable

Funding:

This study was funded by Gazi University.

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No competing interests reported.

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You are reading this latest preprint version

Diagnostic Accuracy of 3D/4D Transvaginal Ultrasound Compared With MRI for Müllerian Uterine Anomalies: A Prospective Study Using Hysteroscopic Confirmation for Septate Uterus

Status:

Version 1

Abstract

Figures

Introduction

Methods

Study Design and Participants

Inclusion and Exclusion Criteria

Imaging Protocols

Magnetic Resonance Imaging (MRI):

Classification and Data Analysis

Results

Patient Characteristics

Imaging Findings

Concordance Between Modalities

Surgical Decision-Making

Discussion

Limitations

Conclusion

Declarations

References

Additional Declarations

Status:

Version 1