Benign descriptors and ADNEX in two-step strategy to estimate risk of malignancy in ovarian tumors: retrospective validation in IOTA5 multicenter cohort.

OBJECTIVE: Previous work has suggested that the ultrasound-based benign simple descriptors (BDs) can reliably exclude malignancy in a large proportion of women presenting with an adnexal mass. This study aimed to validate a modified version of the BDs and to validate a two-step strategy to estimate the risk of malignancy, in which the modified BDs are followed by the Assessment of Different NEoplasias in the adneXa (ADNEX) model if modified BDs do not apply. METHODS: This was a retrospective analysis using data from the 2-year interim analysis of the International Ovarian Tumor Analysis (IOTA) Phase-5 study, in which consecutive patients with at least one adnexal mass were recruited irrespective of subsequent management (conservative or surgery). The main outcome was classification of tumors as benign or malignant, based on histology or on clinical and ultrasound information during 1 year of follow-up. Multiple imputation was used when outcome based on follow-up was uncertain according to predefined criteria. RESULTS: A total of 8519 patients were recruited at 36 centers between 2012 and 2015. We excluded patients who were already in follow-up at recruitment and all patients from 19 centers that did not fulfil our criteria for good-quality surgical and follow-up data, leaving 4905 patients across 17 centers for statistical analysis. Overall, 3441 (70%) tumors were benign, 978 (20%) malignant and 486 (10%) uncertain. The modified BDs were applicable in 1798/4905 (37%) tumors, of which 1786 (99.3%) were benign. The two-step strategy based on ADNEX without CA125 had an area under the receiver-operating-characteristics curve (AUC) of 0.94 (95% CI, 0.92-0.96). The risk of malignancy was slightly underestimated, but calibration varied between centers. A sensitivity analysis in which we expanded the definition of uncertain outcome resulted in 1419 (29%) tumors with uncertain outcome and an AUC of the two-step strategy without CA125 of 0.93 (95% CI, 0.91-0.95). CONCLUSION: A large proportion of adnexal masses can be classified as benign by the modified BDs. For the remaining masses, the ADNEX model can be used to estimate the risk of malignancy. This two-step strategy is convenient for clinical use. © 2022 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Reproductive outcome after early miscarriage: comparing vaginal misoprostol treatment with expectant management in a planned secondary analysis of a randomized controlled trial.

OBJECTIVE: To compare the reproductive outcome after early miscarriage between women managed expectantly and those treated with vaginal misoprostol. METHODS: This study was a planned secondary analysis of data collected prospectively in a randomized controlled trial comparing expectant management with vaginal misoprostol treatment (single dose of 800 µg) in women with early embryonic or anembryonic miscarriage and vaginal bleeding. The outcome measures were the number of women with a clinical pregnancy conceived within 14 months after complete miscarriage and the outcome of these pregnancies in terms of live birth, miscarriage, ectopic pregnancy and legal termination of pregnancy. The participants replied to a questionnaire sent by post covering their reproductive history ≤ 14 months after the index miscarriage was complete. Supplementary information and data for women who did not return their questionnaire were retrieved from medical records. RESULTS: Of 94 women randomized to misoprostol treatment and 95 allocated to expectant management, 94 and 90 women, respectively, were included for analysis. Information on reproductive outcome was available for 89/94 (95%) and 83/90 (92%) women, respectively. Complete miscarriage without surgical evacuation was achieved within 31 days in 85% (76/89) of the women in the misoprostol group and in 65% (54/83) of those managed expectantly. The proportion of women treated with surgical evacuation was 33% (27/83) in the expectant-management group vs 12% (11/89) in the misoprostol group. At 14 months after the index miscarriage was complete, 75% (67/89) of women treated with misoprostol and 75% (62/83) of those managed expectantly had achieved at least one clinical pregnancy, while 40% (36/89) and 35% (29/83), respectively, had had at least one live birth (mean difference, 5.5% (95% CI, -9.7 to 20.3%)). When considering the outcome of all pregnancies conceived within 14 months after the index miscarriage was complete, 63% (56/89) of women in the misoprostol group and 55% (46/83) of those in the expectant-management group delivered a live baby after a pregnancy (mean difference, 7.5% (95% CI, -7.9 to 22.4%)). CONCLUSION: Women with early miscarriage can be reassured that fertility is similar after misoprostol treatment and expectant management. © 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Imaging in gynecological disease (23): clinical and ultrasound characteristics of ovarian carcinosarcoma.

OBJECTIVE: To describe the clinical and ultrasound characteristics of ovarian carcinosarcoma. METHODS: This was a retrospective multicenter study. Patients with a histological diagnosis of ovarian carcinosarcoma, who had undergone preoperative ultrasound examination between 2010 and 2019, were identified from the International Ovarian Tumor Analysis (IOTA) database. Additional patients who were examined outside of the IOTA study were identified from the databases of the participating centers. The masses were described using the terms and definitions of the IOTA group. Additionally, two experienced ultrasound examiners reviewed all available images to identify typical ultrasound features using pattern recognition. RESULTS: Ninety-one patients with ovarian carcinosarcoma who had undergone ultrasound examination were identified, of whom 24 were examined within the IOTA studies and 67 were examined outside of the IOTA studies. Median age at diagnosis was 66 (range, 33-91) years and 84/91 (92.3%) patients were postmenopausal. Most patients (67/91, 73.6%) were symptomatic, with the most common complaint being pain (51/91, 56.0%). Most tumors (67/91, 73.6%) were International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV. Bilateral lesions were observed on ultrasound in 46/91 (50.5%) patients. Ascites was present in 38/91 (41.8%) patients. The median largest tumor diameter was 100 (range, 18-260) mm. All ovarian carcinosarcomas contained solid components, and most were described as solid (66/91, 72.5%) or multilocular-solid (22/91, 24.2%). The median diameter of the largest solid component was 77.5 (range, 11-238) mm. Moderate or rich vascularization was found in 78/91 (85.7%) cases. Retrospective analysis of ultrasound images and videoclips using pattern recognition in 73 cases revealed that all tumors had irregular margins and inhomogeneous echogenicity of the solid components. Forty-seven of 73 (64.4%) masses appeared as a solid tumor with cystic areas. Cooked appearance of the solid tissue was identified in 28/73 (38.4%) tumors. No pathognomonic ultrasound sign of ovarian carcinosarcoma was found. CONCLUSIONS: Ovarian carcinosarcomas are usually diagnosed in postmenopausal women and at an advanced stage. The most common ultrasound appearance is a large solid tumor with irregular margins, inhomogeneous echogenicity of the solid tissue and cystic areas. The second most common pattern is a large multilocular-solid mass with inhomogeneous echogenicity of the solid tissue. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.

Consensus on revised definitions of Morphological Uterus Sonographic Assessment (MUSA) features of adenomyosis: results of modified Delphi procedure.

OBJECTIVES: To evaluate whether the Morphological Uterus Sonographic Assessment (MUSA) features of adenomyosis need to be better defined and, if deemed necessary, to reach consensus on the updated definitions. METHODS: A modified Delphi procedure was performed among European gynecologists with expertise in ultrasound diagnosis of adenomyosis. To identify MUSA features that might need revision, 15 two-dimensional (2D) video recordings (four recordings also included three-dimensional (3D) still images) of transvaginal ultrasound (TVS) examinations of the uterus were presented in the first Delphi round (online questionnaire). Experts were asked to confirm or refute the presence of each of the nine MUSA features of adenomyosis (described in the original MUSA consensus statement) in each of the 15 videoclips and to provide comments. In the second Delphi round (online questionnaire), the results of the first round and suggestions for revision of MUSA features were shared with the experts before they were asked to assess a new set of 2D and 3D still images of TVS examinations and to provide feedback on the proposed revisions. A third Delphi round (virtual group meeting) was conducted to discuss and reach final consensus on revised definitions of MUSA features. Consensus was predefined as at least 66.7% agreement between experts. RESULTS: Of 18 invited experts, 16 agreed to participate in the Delphi procedure. Eleven experts completed and four experts partly finished the first round. The experts identified a need for more detailed definitions of some MUSA features. They recommended use of 3D ultrasound to optimize visualization of the junctional zone. Fifteen experts participated in the second round and reached consensus on the presence or absence of ultrasound features of adenomyosis in most of the still images. Consensus was reached for all revised definitions except those for subendometrial lines and buds and interrupted junctional zone. Thirteen experts joined the online meeting, in which they discussed and agreed on final revisions of the MUSA definitions. There was consensus on the need to distinguish between direct features of adenomyosis, i.e. features indicating presence of ectopic endometrial tissue in the myometrium, and indirect features, i.e. features reflecting changes in the myometrium secondary to presence of endometrial tissue in the myometrium. Myometrial cysts, hyperechogenic islands and echogenic subendometrial lines and buds were classified unanimously as direct features of adenomyosis. Globular uterus, asymmetrical myometrial thickening, fan-shaped shadowing, translesional vascularity, irregular junctional zone and interrupted junctional zone were classified as indirect features of adenomyosis. CONCLUSION: Consensus between gynecologists with expertise in ultrasound diagnosis of adenomyosis was achieved regarding revised definitions of the MUSA features of adenomyosis and on the classification of MUSA features as direct or indirect signs of adenomyosis. © 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Psychological impact of early miscarriage and client satisfaction with treatment: comparison between expectant management and misoprostol treatment in a randomized controlled trial.

OBJECTIVES: To compare the short- and long-term emotional distress (grief, anxiety and depressive symptoms) after early miscarriage and satisfaction with treatment between women randomized to expectant management vs vaginal misoprostol treatment. METHODS: This was a preplanned analysis of data collected during a randomized controlled trial comparing expectant management with misoprostol treatment in women with early anembryonic or embryonic miscarriage and vaginal bleeding. If the miscarriage was not complete on day 31 after inclusion, surgical evacuation was recommended. The main outcomes were levels of anxiety and grief, depressive symptoms and client satisfaction with the treatment, which were assessed using the following validated psychometric self-assessment instruments: Spielberger State-Trait Anxiety Inventory (STAI, Form Y), Perinatal Grief Scale (PGS), Montgomery-Åsberg Depression Rating Scale (MADRS-S; self-reported version) and Client Satisfaction Questionnaire (CSQ-8). All women were assessed at four timepoints: on the day of randomization, on the day when the miscarriage was judged to be complete, and at 3 months and 14 months after complete miscarriage. The psychometric and client satisfaction scores were compared between the misoprostol group and the expectant-management group at each assessment. Analysis was performed by the intention-to-treat principle. RESULTS: Ninety women were randomized to expectant management and 94 to misoprostol treatment. The psychometric and client satisfaction scores were similar in the two treatment groups at all assessment timepoints. At inclusion, 41% (35/86) of the women managed expectantly and 37% (34/92) of those treated with misoprostol had a STAI-state score of > 46 ('high level of anxiety'), and 9% (8/86) and 10% (9/91), respectively, had symptoms of moderate or severe depression (MADRS-S score ≥ 20). In both treatment groups, symptom scores for anxiety and depression were significantly higher at inclusion than after treatment and remained low until 14 months after complete miscarriage. Grief reactions were mild in both groups, with a median PGS score of 40.0 at 3 months and 37.0 at 14 months after complete miscarriage in both treatment groups. Four women treated with misoprostol and two women managed expectantly had a PGS score of > 90 (indicating deep grief) 3 months after complete miscarriage, while one woman managed expectantly had a PGS score of > 90 14 months after complete miscarriage. Women in both treatment groups were satisfied with their management, as indicated by a median CSQ-8 score of > 25 at each assessment. More than 85% of participants in each of the two groups reported that they would recommend the treatment they received to a friend. CONCLUSIONS: The psychological response to and recovery after early miscarriage did not differ between women treated with misoprostol and those managed expectantly. Satisfaction with treatment was high in both treatment groups. Our findings support patient involvement when deciding on the management of early miscarriage. © 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Vessel morphology depicted by three-dimensional power Doppler ultrasound as second-stage test in adnexal tumors that are difficult to classify: prospective diagnostic accuracy study.

OBJECTIVES: To assess whether vessel morphology depicted by three-dimensional (3D) power Doppler ultrasound improves discrimination between benignity and malignancy if used as a second-stage test in adnexal masses that are difficult to classify. METHODS: This was a prospective observational international multicenter diagnostic accuracy study. Consecutive patients with an adnexal mass underwent standardized transvaginal two-dimensional (2D) grayscale and color or power Doppler and 3D power Doppler ultrasound examination by an experienced examiner, and those with a 'difficult' tumor were included in the current analysis. A difficult tumor was defined as one in which the International Ovarian Tumor Analysis (IOTA) logistic regression model-1 (LR-1) yielded an ambiguous result (risk of malignancy, 8.3% to 25.5%), or as one in which the ultrasound examiner was uncertain regarding classification as benign or malignant when using subjective assessment. Even when the ultrasound examiner was uncertain, he/she was obliged to classify the tumor as most probably benign or most probably malignant. For each difficult tumor, one researcher created a 360° rotating 3D power Doppler image of the vessel tree in the whole tumor and another of the vessel tree in a 5-cm3 spherical volume selected from the most vascularized part of the tumor. Two other researchers, blinded to the patient's history, 2D ultrasound findings and histological diagnosis, independently described the vessel tree using predetermined vessel features. Their agreed classification was used. The reference standard was the histological diagnosis of the mass. The sensitivity of each test for discriminating between benign and malignant difficult tumors was plotted against 1 - specificity on a receiver-operating-characteristics diagram, and the test with the point furthest from the reference line was considered to have the best diagnostic ability. RESULTS: Of 2403 women with an adnexal mass, 376 (16%) had a difficult mass. Ultrasound volumes were available for 138 of these cases. In 79/138 masses, the ultrasound examiner was uncertain about the diagnosis based on subjective assessment, in 87/138, IOTA LR-1 yielded an ambiguous result and, in 28/138, both methods gave an uncertain result. Of the masses, 38/138 (28%) were malignant. Among tumors that were difficult to classify as benign or malignant by subjective assessment, the vessel feature 'densely packed vessels' had the best discriminative ability (sensitivity 67% (18/27), specificity 83% (43/52)) and was slightly superior to subjective assessment (sensitivity 74% (20/27), specificity 60% (31/52)). In tumors in which IOTA LR-1 yielded an ambiguous result, subjective assessment (sensitivity 82% (14/17), specificity 79% (55/70)) was superior to the best vascular feature, i.e. changes in the diameter of vessels in the whole tumor volume (sensitivity 71% (12/17), specificity 69% (48/70)). CONCLUSION: Vessel morphology depicted by 3D power Doppler ultrasound may slightly improve discrimination between benign and malignant adnexal tumors that are difficult to classify by subjective ultrasound assessment. For tumors in which the IOTA LR-1 model yields an ambiguous result, subjective assessment is superior to vessel morphology as a second-stage test. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Typical ultrasound features of various endometrial pathologies described using International Endometrial Tumor Analysis (IETA) terminology in women with abnormal uterine bleeding.

OBJECTIVE: To describe the ultrasound features of different endometrial and other intracavitary pathologies inpre- and postmenopausal women presenting with abnormal uterine bleeding, using the International Endometrial Tumor Analysis (IETA) terminology. METHODS: This was a prospective observational multicenter study of consecutive women presenting with abnormal uterine bleeding. Unenhanced sonography with color Doppler and fluid-instillation sonography were performed. Endometrial sampling was performed according to each center's local protocol. The histological endpoints were cancer, atypical endometrial hyperplasia/endometrioid intraepithelial neoplasia (EIN), endometrial atrophy, proliferative or secretory endometrium, endometrial hyperplasia without atypia, endometrial polyp, intracavitary leiomyoma and other. For fluid-instillation sonography, the histological endpoints were endometrial polyp, intracavitary leiomyoma and cancer. For each histological endpoint, we report typical ultrasound features using the IETA terminology. RESULTS: The database consisted of 2856 consecutive women presenting with abnormal uterine bleeding. Unenhanced sonography with color Doppler was performed in all cases and fluid-instillation sonography in 1857. In 2216 women, endometrial histology was available, and these comprised the study population. Median age was 49 years (range, 19-92 years), median parity was 2 (range, 0-10) and median body mass index was 24.9 kg/m2 (range, 16.0-72.1 kg/m2 ). Of the study population, 843 (38.0%) women were postmenopausal. Endometrial polyps were diagnosed in 751 (33.9%) women, intracavitary leiomyomas in 223 (10.1%) and endometrial cancer in 137 (6.2%). None (0% (95% CI, 0.0-5.5%)) of the 66 women with endometrial thickness < 3 mm had endometrial cancer or atypical hyperplasia/EIN. Endometrial cancer or atypical hyperplasia/EIN was found in three of 283 (1.1% (95% CI, 0.4-3.1%)) endometria with a three-layer pattern, in three of 459 (0.7% (95% CI, 0.2-1.9%)) endometria with a linear endometrial midline and in five of 337 (1.5% (95% CI, 0.6-3.4%)) cases with a single vessel without branching on unenhanced ultrasound. CONCLUSIONS: The typical ultrasound features of endometrial cancer, polyps, hyperplasia and atrophy and intracavitary leiomyomas, are described using the IETA terminology. The detection of some easy-to-assess IETA features (i.e. endometrial thickness < 3 mm, three-layer pattern, linear midline and single vessel without branching) makes endometrial cancer unlikely. Copyright © 2020 ISUOG. Published by John Wiley & Sons Ltd.

Misoprostol treatment vs expectant management in women with early non-viable pregnancy and vaginal bleeding: a pragmatic randomized controlled trial.

OBJECTIVE: To compare vaginal misoprostol treatment with expectant management in early non-viable pregnancy with vaginal bleeding with regard to complete evacuation of the uterine cavity within 10 days after randomization. METHODS: This was a parallel randomized controlled, open-label trial conducted in Skåne University Hospital, Sweden. Patients with anembryonic pregnancy or early fetal demise (crown-rump length ≤ 33 mm) and vaginal bleeding were randomly allocated to either expectant management or treatment with a single dose of 800 µg misoprostol administered vaginally. Patients were evaluated clinically and by ultrasound until complete evacuation of the uterus was achieved (no gestational sac in the uterine cavity and maximum anteroposterior diameter of the intracavitary contents < 15 mm as measured by transvaginal ultrasound on midsagittal view). Follow-up visits were planned at 10, 17, 24 and 31 days. Dilatation and evacuation (D&E) was recommended if miscarriage was not complete within 31 days, but was performed earlier at patient's request, or if there was excessive bleeding as judged clinically. Analysis was by intention to treat. The main outcome measure was number of patients with complete miscarriage without D&E ≤ 10 days. RESULTS: Ninety-four patients were randomized to misoprostol treatment and 95 to expectant management. After exclusion of three patients and withdrawal of consent by two patients in the expectant management group, 90 women were included in this group. Miscarriage was complete ≤ 10 days in 62/94 (66%) of the patients in the misoprostol group and in 39/90 (43%) of those in the group managed expectantly (risk difference (RD) = 23%; 95% CI, 8-37%). At 31 days, the corresponding figures were 81/94 (86%) and 55/90 (61%) (RD = 25%; 95% CI, 12-38%). Two patients from each group underwent emergency D&E because of excessive bleeding and one of these in each group received blood transfusion. The number of patients undergoing D&E at their own request was higher in the expectantly managed group, 15/90 (17%) vs 3/94 (3%) in the misoprostol group (RD = 14%; 95% CI, 4-23%), as was the number of patients making out-of-protocol visits, 50/90 (56%) vs 27/94 (29%) (RD = 27%; 95% CI, 12-40%). Compared with the expectant management group, more patients in the misoprostol group experienced pain (71/77 (92%) vs 91/91 (100%); RD = 8%; 95% CI, 1-17%) and used painkillers (59/77 (77%) vs 85/91 (93%); RD = 17%; 95% CI, 5-29%). No major side effect was reported in any group. CONCLUSIONS: In women with early non-viable pregnancy and vaginal bleeding, misoprostol treatment is more effective than is expectant management for complete evacuation of the uterus. Both methods are safe but misoprostol treatment is associated with more pain than is expectant management. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

Counting ovarian antral follicles by ultrasound: a practical guide.

This Consensus Opinion summarizes the main aspects of several techniques for performing ovarian antral follicle count (AFC), proposes a standardized report and provides recommendations for future research. AFC should be performed using a transvaginal ultrasound (US) probe with frequency ≥ 7 MHz. For training, we suggest a minimum of 20-40 supervised examinations. The operator should be able to adjust the machine settings in order to achieve the best contrast between follicular fluid and ovarian stroma. AFC may be evaluated using real-time two-dimensional (2D) US, stored 2D-US cine-loops and stored three-dimensional (3D) US datasets. Real-time 2D-US has the advantage of permitting additional maneuvers to determine whether an anechoic structure is a follicle, but may require a longer scanning time, particularly when there is a large number of follicles, resulting in more discomfort to the patient. 2D-US cine-loops have the advantages of reduced scanning time and the possibility for other observers to perform the count. The 3D-US technique requires US machines with 3D capability and the operators to receive additional training for acquisition/analysis, but has the same advantages as cine-loop and also allows application of different imaging techniques, such as volume contrast imaging, inversion mode and semi-automated techniques such as sonography-based automated volume calculation. In this Consensus Opinion, we make certain recommendations based on the available evidence. However, there is no strong evidence that any one method is better than another; the operator should choose the best method for counting ovarian follicles based on availability of resources and on their own preference and skill. More studies evaluating how to improve the reliability of AFC should be encouraged. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

International Endometrial Tumor Analysis (IETA) terminology in women with postmenopausal bleeding and sonographic endometrial thickness ≥ 4.5 mm: agreement and reliability study.

OBJECTIVE: To estimate intra- and interrater agreement and reliability with regard to describing ultrasound images of the endometrium using the International Endometrial Tumor Analysis (IETA) terminology. METHODS: Four expert and four non-expert raters assessed videoclips of transvaginal ultrasound examinations of the endometrium obtained from 99 women with postmenopausal bleeding and sonographic endometrial thickness ≥ 4.5 mm but without fluid in the uterine cavity. The following features were rated: endometrial echogenicity, endometrial midline, bright edge, endometrial-myometrial junction, color score, vascular pattern, irregularly branching vessels and color splashes. The color content of the endometrial scan was estimated using a visual analog scale graded from 0 to 100. To estimate intrarater agreement and reliability, the same videoclips were assessed twice with a minimum of 2 months' interval. The raters were blinded to their own results and to those of the other raters. RESULTS: Interrater differences in the described prevalence of most IETA variables were substantial, and some variable categories were observed rarely. Specific agreement was poor for variables with many categories. For binary variables, specific agreement was better for absence than for presence of a category. For variables with more than two outcome categories, specific agreement for expert and non-expert raters was best for not-defined endometrial midline (93% and 96%), regular endometrial-myometrial junction (72% and 70%) and three-layer endometrial pattern (67% and 56%). The grayscale ultrasound variable with the best reliability was uniform vs non-uniform echogenicity (multirater kappa (κ), 0.55 for expert and 0.52 for non-expert raters), and the variables with the lowest reliability were appearance of the endometrial-myometrial junction (κ, 0.25 and 0.16) and the nine-category endometrial echogenicity variable (κ, 0.29 and 0.28). The most reliable color Doppler variable was color score (mean weighted κ, 0.77 and 0.69). Intra- and interrater agreement and reliability were similar for experts and non-experts. CONCLUSIONS: Inter- and intrarater agreement and reliability when using IETA terminology were limited. This may have implications when assessing the association between a particular ultrasound feature and a specific histological diagnosis, because lack of reproducibility reduces the reliability of the association between a feature and the outcome. Future studies should investigate whether using fewer categories of variable or offering practical training could improve agreement and reliability. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

Transvaginal ultrasound examination of the endometrium in postmenopausal women without vaginal bleeding.

OBJECTIVES: To estimate in gynecologically asymptomatic postmenopausal women with and without hormone replacement therapy (HRT) undergoing transvaginal ultrasound examination the prevalence of: endometrial thickness ≥ 5.0 mm, intrauterine focal lesions if endometrial thickness is ≥ 5.0 mm, and premalignant and malignant endometrial changes if thickness is ≥ 5.0 mm and intrauterine focal lesions are present. METHODS: Invitation letters were sent to 2951 potentially eligible women recruited from a Swedish population registry; 757 replied, 514 were considered eligible (i.e. were gynecologically asymptomatic postmenopausal women aged 52-62 years with no current or previous gynecological problems) and 510 had complete information and were included. The women were examined using transvaginal ultrasound (5-9-MHz transducer). If endometrial thickness was ≥ 5.0 mm, saline contrast sonohysterography (SCSH) was attempted. The number, size and surface contour of intracavitary focal lesions were recorded. Women with focal lesions were offered hysteroscopic resection of the lesions. Gold standard was histology of the surgical specimen. RESULTS: The median time in menopause was 5 (range, 1-17) years. There were no substantial differences in ultrasound findings between women with HRT and those without. Sixty-two (12% (95% CI, 9-15%)) women had an endometrial thickness ≥ 5.0 mm. SCSH was attempted in 54 of these women, which was successful in 48 and suboptimal in one. Thirty-three (67%) of the 49 women with successful or suboptimal SCSH and one woman with spontaneous fluid in the uterine cavity had intracavitary focal lesions. Twenty-nine of these women with focal lesions underwent hysteroscopic resection of the lesion(s). Two cases of endometrial complex hyperplasia with atypia but no malignancy were found. Uterine perforation with bowel damage occurred in two women who underwent hysteroscopic surgery. CONCLUSION: About 10% of gynecologically asymptomatic postmenopausal women have a sonographic endometrial thickness ≥ 5.0 mm. Our results support conservative management of such women. Copyright © 2015 ISUOG. Published by John Wiley & Sons Ltd.

Appearance of the endometrium at saline contrast sonohysterography in the luteal phase of the menstrual cycle: a prospective observational study.

OBJECTIVE: To describe the ultrasonographic morphology of the endometrium at saline contrast sonohysterography (SCSH) performed in the luteal phase of the menstrual cycle in women 20-38 years of age with regular menstrual cycles. METHODS: The study included 26 women (median age 33 (range, 20-38) years) with regular menstrual cycles referred for hysterosalpingo-contrast sonography (HyCoSy) as part of infertility work-up (n = 19) or before donor insemination in lesbian couples (n = 7). SCSH and HyCoSy were performed 6-10 days after a positive luteinizing hormone (LH) urinary self-test. Three-dimensional (3D) ultrasound volumes of the uterus were saved with and without saline in the uterine cavity. The results presented are based on offline analysis of the 3D volumes. RESULTS: Median endometrial thickness was 10.4 (range, 6.0-17.3) mm. Twelve (46%; 95% CI, 27-65%) of the 26 women had endometrial folds at SCSH. The number of folds varied between 1 and 6 (median 3). Endometrial thickness was similar in women with and without endometrial folds (median endometrial thickness 10.7 (range, 6.0-17.3) mm vs 10.1 (range, 6.1-14.4) mm; P = 0.257), and the amount of saline in the uterine cavity did not differ between the two groups (median 8.6 (range, 5.2-12.9) mm vs 7.1 (range, 3.2-13.3) mm; P = 0.527). In two women with endometrial folds at two-dimensional (2D) or 3D-SCSH, focal endometrial pathology (polyp) was suspected, but hysteroscopically resected endometrium showed normal histology. CONCLUSIONS: One should avoid performing SCSH in the luteal phase of the menstrual cycle, not only because there may be a fertilized ovum in the genital tract but also because endometrial folds are common in this phase and may lead to overdiagnosis of focal endometrial pathology, such as polyps. If, for some reason, SCSH is performed in the luteal phase and the results are equivocal, the procedure should be repeated in the follicular phase.

Transvaginal ultrasound assessment of myometrial and cervical stromal invasion in women with endometrial cancer: interobserver reproducibility among ultrasound experts and gynecologists.

OBJECTIVES: To assess interobserver reproducibility among ultrasound experts and gynecologists in the prediction by transvaginal ultrasound of deep myometrial and cervical stromal invasion in women with endometrial cancer. METHODS: Sonographic videoclips of the uterine corpus and cervix of 53 women with endometrial cancer, examined preoperatively by the same ultrasound expert, were integrated into a digitalized survey. Nine ultrasound experts and nine gynecologists evaluated presence or absence of deep myometrial and cervical stromal invasion. Histopathology from hysterectomy specimens was used as the gold standard. RESULTS: Compared with gynecologists, ultrasound experts showed higher sensitivity, specificity and agreement with histopathology in the assessment of cervical stromal invasion (42% (95% CI, 31-53%) vs 57% (95% CI, 45-68%), P < 0.01; 83% (95% CI, 78-86%) vs 87% (95% CI, 83-90%), P = 0.02; and kappa, 0.45 (95% CI, 0.40-0.49) vs 0.58 (95% CI, 0.53-0.62), P < 0.001, respectively) but not of deep myometrial invasion (73% (95% CI, 66-79%) vs 73% (95% CI, 66-79%), P = 1.0; 70% (95% CI, 65-75%) vs 69% (95% CI, 63-74%), P = 0.68; and kappa, 0.48 (95% CI, 0.44-0.53) vs 0.52 (95% CI, 0.48-0.57), P = 0.11, respectively). Though interobserver reproducibility (in the context of test proportions 'good' and 'very good', according to kappa) regarding deep myometrial invasion did not differ between the groups (experts, 34% vs gynecologists, 22%, P = 0.13), ultrasound experts assessed cervical stromal invasion with significantly greater interobserver reproducibility than did gynecologists (53% vs 14%, P < 0.001). CONCLUSION: Preoperative ultrasound assessment of deep myometrial and cervical stromal invasion in endometrial cancer is best performed by ultrasound experts, as, compared with gynecologists, they showed a greater degree of agreement with histopathology and greater interobserver reproducibility in the assessment of cervical stromal invasion.

Prevalence of extrauterine pelvic lesions on transvaginal ultrasound in asymptomatic 20-39-year-old women.

OBJECTIVES: To estimate the prevalence of extrauterine pelvic lesions on transvaginal ultrasound examination of gynecologically asymptomatic women of fertile age, and to compare this prevalence between women with spontaneous menstrual cycles, those using the combined oral contraceptive (COC) pill and those using a gestagen intrauterine contraceptive device (IUD). METHODS: Six hundred and forty-four gynecologically asymptomatic 20-39-year-old Caucasian women with no current or previous gynecological problems, who were recruited from a Swedish population registry, were examined with transvaginal ultrasound on cycle day 4-8. Our definition of ovarian cyst was a unilocular cyst with anechoic cyst contents ≥ 35 mm in mean diameter, or any other type of intraovarian lesion. The prevalence of extrauterine pelvic lesions was compared between women not using hormonal contraception and those using COC or a gestagen IUD. RESULTS: Ovarian lesions were found in 24 (3.7%) women. One woman had bilateral ovarian lesions. An ultrasound diagnosis of paraovarian cyst was made in 41 (6.4%) women, of peritoneal cyst in four (0.6%) women and of hydrosalpinx in one (0.2%) woman. All incidentally detected lesions had a mean diameter of ≤ 5 cm. One 17-mm intraovarian lesion was suspicious for malignancy, and histology confirmed a Sertoli-Leydig cell tumor. The ultrasound diagnoses in the remaining 23 women were endometrioma (n = 10 (1.6%)), dermoid cyst (n = 5 (0.8%)), cystadenofibroma (n = 1 (0.2%)), mature teratoma (n = 1 (0.2%)) and functional cyst, i.e. a cyst that resolved within 3-5 months (n = 6 (0.9%)). Four women with an ultrasound diagnosis of a benign lesion were operated on, and the ultrasound diagnoses of endometrioma (n = 2), dermoid cyst (n = 1) and mature teratoma (n = 1) were confirmed histologically. The prevalence of persisting ovarian lesions was highest in women with spontaneous menstrual cycles (4.4% vs 0.9% and 0% in women using COC and gestagen IUD, respectively; P = 0.025), but age was the only factor independently associated with persisting ovarian masses, the prevalence increasing with age. CONCLUSIONS: Benign ovarian lesions are found in about 1 in 25 gynecologically asymptomatic women aged 20-39 years with no history of gynecological disease. To be able to offer optimal management of such masses, their natural history needs to be elucidated in a large prospective observational study.

Intra- and interobserver agreement with regard to describing adnexal masses using International Ovarian Tumor Analysis terminology: reproducibility study involving seven observers.

OBJECTIVES: To estimate intraobserver repeatability and interobserver agreement in assessing the presence of papillary projections in adnexal masses and in classifying adnexal masses using the International Ovarian Tumor Analysis terminology for ultrasound examiners with different levels of experience. We also aimed to identify ultrasound findings that cause confusion and might be interpreted differently by different observers, and to determine if repeatability and agreement change after consensus has been reached on how to interpret 'problematic' ultrasound images. METHODS: Digital clips (two to eight clips per adnexal mass) with gray-scale and color/power Doppler information of 83 adnexal masses in 80 patients were evaluated independently four times, twice before and twice after a consensus meeting, by four experienced and three less experienced ultrasound observers. The variables analyzed were tumor type (unilocular, unilocular solid, multilocular, multilocular solid, solid) and presence of papillary projections. Intraobserver repeatability was evaluated for each observer (percentage agreement, Cohen's kappa). Interobserver agreement was estimated for all seven observers (percentage agreement, Fleiss kappa, Cohen's kappa). RESULTS: There was uncertainty about how to define a solid component and a papillary projection, but consensus was reached at the consensus meeting. Interobserver agreement for tumor type was good both before and after the consensus meeting, with no clear improvement after the meeting, mean percentage agreement being 76.0% (Fleiss kappa, 0.695) before the meeting and 75.4% (Fleiss kappa, 0.682) after the meeting. Interobserver agreement with regard to papillary projections was moderate both before and after the consensus meeting, with no clear improvement after the meeting, mean percentage agreement being 86.6% (Fleiss kappa, 0.536) before the meeting and 82.7% (Fleiss kappa, 0.487) after it. There was substantial variability in pairwise agreement for papillary projections (Cohen's kappa, 0.148-0.787). Intraobserver repeatability with regard to tumor type was very good and similar before and after the consensus meeting (agreement 87-95%, kappa, 0.83-0.94). With regard to papillary projections intraobserver repeatability was good or very good both before and after the consensus meeting (agreement 88-100%, kappa, 0.64-1.0). CONCLUSIONS: Despite uncertainty about how to define solid components, interobserver agreement was good for tumor type. The interobserver agreement for papillary projection was moderate but very variable between observer pairs. The term 'papillary projection' might need a more precise definition. The consensus meeting did not change inter- or intraobserver agreement.

Intra- and interobserver reproducibility of assessment of Doppler ultrasound findings in adnexal masses.

OBJECTIVES: To estimate intra- and interobserver reproducibility and reliability of assessment of the color content in adnexal masses at color/power Doppler ultrasound examination for observers with different levels of experience, and to determine if they change after a consensus meeting. METHODS: Digital clips with color/power Doppler information on 103 adnexal masses were evaluated independently four times, twice before and twice after a consensus meeting, by four experienced and three less experienced ultrasound examiners. The color content of the adnexal mass was estimated using the International Ovarian Tumor Analysis color score and a 100-mm visual analog scale (VAS score). Intraobserver repeatability was estimated for each observer. Interobserver agreement was estimated for the four most experienced observers (six pairs), for the three less experienced observers (three pairs), and for four other pairs of observers, each pair consisting of one of the experienced and one of the less-experienced observers. RESULTS: Intra- and interobserver agreement for the color score was moderate to very good, percentage agreement ranging from 48 to 82.5% (kappa, 0.52-0.82) before and from 59 to 90% (kappa, 0.60-0.88) after the consensus meeting. For seven of 13 pairs of observers, interobserver agreement improved after the consensus meeting. Intraobserver intraclass correlation coefficient (ICC) values for the VAS score ranged from 0.80 to 0.92 before and from 0.75 to 0.94 after the consensus meeting, but limits of agreement were wide (± 20-35 mm). For six of the seven observers the ICC values were higher after the consensus meeting than before. Interobserver ICC values for the VAS score ranged from 0.77 to 0.88 before and from 0.77 to 0.91 after the consensus meeting, but limits of agreement were wide (± 30-40 mm). For 10 of 13 pairs of observers the ICC values improved after the consensus meeting. CONCLUSIONS: Intra- and interobserver agreement for the color score was good, especially after the consensus meeting, but there is room for improvement. VAS score results varied substantially within and between observers both before and after the consensus meeting. General consensus needs to be reached about how to interpret color/power Doppler ultrasound findings in adnexal masses.

Cesarean section scar defects: agreement between transvaginal sonographic findings with and without saline contrast enhancement.

OBJECTIVES: To determine the agreement between transvaginal ultrasound examinations performed before and at saline contrast sonohysterography (SCSH) with regard to number, size and shape of Cesarean section (CS) scar defects. METHODS: In all, 108 women underwent transvaginal ultrasound examination with SCSH at least 6 months after CS: 68 had undergone one CS, 32 two CSs and eight women had undergone at least three CSs. The ultrasound examiner was blinded to the number of CSs and to the obstetric history. The number and shape of CS scar defects were determined subjectively, and any scar defect was estimated subjectively to be large or not large. Measurements of the scar defects were also taken. Results obtained before and at SCSH were compared. RESULTS: Most scar defects were triangular in shape. The shape did not change at SCSH, but the ultrasound examiner found it easier to delineate the borders of the scar defects at SCSH than at unenhanced ultrasound examination. More scar defects were seen and more scar defects were classified as large at SCSH than before: among the 100 women who had undergone one or two CSs, 16 additional women had large defects at SCSH, whereas no woman with a large defect before SCSH had no defect or only a small defect at SCSH. The length and height of the defects were larger at SCSH than before: mean difference 2 mm and 1 mm in women who had undergone one CS, and mean difference 4 mm and 2 mm in the lowest-positioned scar in women who had undergone two CSs. CONCLUSIONS: In non-pregnant women CS scars were better evaluated at SCSH than at unenhanced ultrasound examination, because the demarcations of scar defects were more clearly delineated at SCSH than before. More defects were detected and more defects were classified as large at SCSH.

Three-dimensional ultrasound imaging for discrimination between benign and malignant endometrium in women with postmenopausal bleeding and sonographic endometrial thickness of at least 4.5 mm.

OBJECTIVES: To determine whether endometrial volume or power Doppler indices as measured by three-dimensional (3D) ultrasound imaging can discriminate between benign and malignant endometrium, to compare their diagnostic performance with that of endometrial thickness measurement using two-dimensional (2D) ultrasound examination, and to determine whether power Doppler indices add any diagnostic information to endometrial thickness or volume. METHODS: Sixty-two patients with postmenopausal bleeding and endometrial thickness > or = 4.5 mm underwent transvaginal 2D gray-scale and 3D power Doppler ultrasound examination of the corpus uteri. The endometrial volume was calculated, along with the vascularization index (VI), flow index and vascularization flow index (VFI) in the endometrium and in a 2-mm 'shell' surrounding the endometrium. The 'gold standard' was the histological diagnosis of the endometrium obtained by hysteroscopic resection of focal lesions, dilatation and curettage or hysterectomy. Receiver-operating characteristics (ROC) curves were drawn for all measurements to evaluate their ability to distinguish between benign and malignant endometrium. Multivariate logistic regression analysis was used to create mathematical models to estimate the risk of endometrial malignancy. RESULTS: There were 49 benign and 13 malignant endometria. Endometrial thickness and volume were significantly larger in malignant than in benign endometria, and flow indices in the endometrium and endometrial shell were significantly higher. The area under the ROC curve (AUC) of endometrial thickness was 0.82, that of endometrial volume 0.78, and that of the two best power Doppler variables (VI and VFI in the endometrium) 0.82 and 0.82. The best logistic regression model for predicting malignancy contained the variables endometrial thickness (odds ratio 1.2; 95% CI, 1.04-1.30; P = 0.004) and VI in the endometrial 'shell' (odds ratio 1.1; 95% CI, 1.02-1.23; P = 0.01). Its AUC was 0.86. Using its mathematically optimal risk cut-off value (0.22), the model correctly classified seven more benign cases but two fewer malignant cases than the best endometrial thickness cut-off (11.8 mm). Models containing endometrial volume and flow indices performed less well than did endometrial thickness alone (AUC, 0.79 vs. 0.82). CONCLUSIONS: The diagnostic performance for discrimination between benign and malignant endometrium of 3D ultrasound imaging was not superior to that of endometrial thickness as measured by 2D ultrasound examination, and 3D power Doppler imaging added little to endometrial thickness or volume.

High prevalence of defects in Cesarean section scars at transvaginal ultrasound examination.

OBJECTIVES: To determine the ability to correctly identify Cesarean section scars, to estimate the prevalence of defective scars, and to determine the size and location of scar defects by transvaginal ultrasound imaging. METHODS: Two hundred and eighty-seven women underwent transvaginal ultrasound examination 6-9 months after delivery: 108 had undergone one Cesarean section, 43 had had two Cesarean sections, 11 had undergone at least three Cesarean sections, and 125 were primiparae who had delivered vaginally. The ultrasound examiner was blinded to the obstetric history until all scans had been evaluated. RESULTS: None of the 125 vaginally delivered women had a visible scar in the uterus, whereas all women who had undergone Cesarean section had at least one visible scar. Median myometrial thickness at the level of the isthmus was 11.6 mm in women who had only been delivered vaginally, and 8.3 mm, 6.7 mm and 4.7 mm in women who had undergone one, two and at least three Cesarean sections, respectively (P < 0.001). Scar defects were seen in 61% (66/108), 81% (35/43) and 100% (11/11) of the women who had undergone one, two and at least three Cesarean sections (P = 0.002); at least one defect was classified as large by the ultrasound examiner in 14% (15/108), 23% (10/43) and 45% (5/11) (P = 0.027), and at least one total defect was seen in 6% (7/108), 7% (3/43) and 18% (2/11) (P = 0.336). In women who had undergone one Cesarean section, the median distance between an intact scar and the internal cervical os was 4.6 (range, 0-19) mm, and that between a deficient scar and the internal cervical os was 0 (range, 0-26) mm (P < 0.001). CONCLUSIONS: Cesarean section scars can be detected reliably by ultrasound imaging. Myometrial thickness at the level of the isthmus uteri decreases with the number of Cesarean sections and the frequency of large scar defects increases. Scars with defects are located lower in the uterus than intact scars.