Risk assessment for endometrial cancer in women with abnormal vaginal bleeding: Results from the prospective IETA-1 cohort study.

OBJECTIVE: To investigate the association between personal history, anthropometric features and lifestyle characteristics and endometrial malignancy in women with abnormal vaginal bleeding. METHODS: Prospective observational cohort assessed by descriptive and multivariable logistic regression analyses. Three features-age, body mass index (BMI; calculated as weight in kilograms divided by the square of height in meters), and nulliparity-were defined a priori for baseline risk assessment of endometrial malignancy. The following variables were tested for added value: intrauterine contraceptive device, bleeding pattern, age at menopause, coexisting diabetes/hypertension, physical exercise, fat distribution, bra size, waist circumference, smoking/drinking habits, family history, use of hormonal/anticoagulant therapy, and sonographic endometrial thickness. We calculated adjusted odds ratio, optimism-corrected area under the receiver operating characteristic curve (AUC), R2 , and Akaike's information criterion. RESULTS: Of 2417 women, 155 (6%) had endometrial malignancy or endometrial intraepithelial neoplasia. In women with endometrial cancer median age was 67 years (interquartile range [IQR] 56-75 years), median parity was 2 (IQR 0-10), and median BMI was 28 (IQR 25-32). Age, BMI, and parity produced an AUC of 0.82. Other variables marginally affected the AUC, adding endometrial thickness substantially increased the AUC in postmenopausal women. CONCLUSION: Age, parity, and BMI help in the assessment of endometrial cancer risk in women with abnormal uterine bleeding. Other patient information adds little, whereas sonographic endometrial thickness substantially improves assessment.

Added Value of Quantitative Analysis of Diffusion-Weighted Imaging in Ovarian-Adnexal Reporting and Data System Magnetic Resonance Imaging.

BACKGROUND: The ovarian-adnexal reporting and data system-magnetic resonance imaging (O-RADS-MRI) score decreases the incidence of indeterminate adnexal masses from 18% to 31% with ultrasound till 10.8% to 12.5% with MRI. Further improvement of this score may be useful to improve patients' management. PURPOSE: To evaluate the added value of quantitative diffusion-weighted imaging (DWI) in the diagnosis of adnexal masses classified according to the O-RADS-MRI score. STUDY TYPE: Prospective cohort study with retrospective DWI analysis. POPULATION: Among 402 recruited patients, surgery was done only in 163 women (median-age: 51 years) with 201 indeterminate adnexal masses, which were included in the final analysis. FIELD STRENGTH/SEQUENCE: Standardized MRI (1.5 and 3-T) including diffusion and dynamic contrast-enhanced sequences (diffusion-weighted single-shot spin-echo echo-planar imaging) were used. ASSESSMENT: Two radiologists classified the adnexal masses according to O-RADS-MRI and they were blinded to the pathology report. Two methods of quantitative analysis were applied using region-of-interest apparent-diffusion-coefficient (ROI-ADC) and whole-lesion ADC-histogram (WL-ADC). STATISTICAL TESTS: Fisher's exact and Mann-Whitney-U tests were used to compare variables among malignant and benign lesions. Receiver-operating-characteristic (ROC) curves were constructed to examine the sensitivity/specificity of each parameter. ROI-ADC and WL-ADC of lesions with O-RADS-MRI score-4 were plotted to identify thresholds of malignant lesions. The improvement of the O-RADS-MRI score after adding these thresholds was assessed by two ROC-curves. A P < 0.05 was considered to be statistically significant. RESULTS: Fifty-eight of the 201 lesions (28.9%) were malignant. The ROI-ADC and the WL-ADC means of malignant lesions were significantly lower than those of benign lesions. Forty-two lesions (20.9%) had an O-RADS-MRI score-4. In this subgroup, 76% of lesions with ROI-ADC < 1.7 × 10-3  mm2 /sec and WL-ADC < 2.6 × 10-3  mm2 /sec were malignant, whereas only 11.8% with ROI-ADC ≥ 1.7 × 10-3  mm2 /sec or a WL-ADC ≥ 2.6 × 10-3  mm2 /sec were malignant. The overall performance of the O-RADS-MRI score combined with these thresholds was improved. DATA CONCLUSION: Integrating ADC-thresholds in O-RADS-MRI score-4 may discriminate low-to-intermediate and intermediate-to-high malignancy risk groups. LEVEL OF EVIDENCE: 2 TECHNICAL EFFICACY STAGE: 2.

Effectiveness and acceptability of "at home" versus "at hospital" early medical abortion - A lesson from the COVID-19 pandemic: A retrospective cohort study.

BACKGROUND: Since the lockdown caused by the COVID-19 pandemic, restrictions on hospitals' activity forced healthcare practitioners to innovate in order to provide continuity of care to patients. The aim of this study was to evaluate the efficiency of a newly established protocol for medical abortion and to measure the level of satisfaction of the patients who experienced abortion at home. METHODS: This retrospective study compared all the patients who had an early medical abortion at up to 9 weeks of gestation during the two drastically different periods between December 2018 and March 2021 ("hospital" and "home" groups). We evaluated the expulsion of the gestational sac as a primary outcome. The rates of infection, hemorrhage, retained trophoblastic material and need for surgical management were also assessed. A survey was also used to measure the satisfaction and acceptability of the method. RESULTS: The rate of expulsion of pregnancy was not significantly different between the two groups: 92.9% in hospital versus 99% at home. Early retained trophoblastic material and surgical interventions were higher in the hospital group. No significant difference was observed for the remaining outcomes. Moreover, the level of acceptability was similar in both groups, though patients felt safer in the "hospital" group. CONCLUSION: Switching an early medical abortion protocol from expulsion of pregnancy in hospital to expulsion of pregnancy at home is effective and acceptable to women, and may be associated with decreased rate of retained trophoblastic material. Further larger studies are needed to test the long-term result of this protocol.

Safety and tolerance of cidofovir as a 2% gel for local application in high-grade cervical intraepithelial neoplasia: A phase 1 investigation.

OBJECTIVES: The primary objective was to evaluate the safety and local tolerance of a topical 2% (w/w) cidofovir gel, applied directly to the cervices of women with high-grade cervical intraepithelial neoplasia (CIN 2+). The secondary objective was to evaluate the pharmacokinetics of cidofovir during the treatment. MATERIALS AND METHODS: Nine women with CIN 2+, were treated with a course of 3 g of cidofovir gel, applied locally once per week for 3 weeks in total (9 g). The treatment was administered in a cervical cap, applied to the cervix for 5 or 10 hours (n = 6 and 3 patients, respectively). Follow-up included a structured questionnaire, a gynecological examination, blood analysis for hematology, C-reactive protein (CRP), and renal function assessment plus pharmacokinetic analyses of cidofovir after each treatment and at the end of the full course. RESULTS: No clinically significant hematological/biochemical abnormalities or serious adverse events (SAE) were reported, although 6 mild to moderate adverse events (AE) occurred in relation to the study drug: 1 flu-like syndrome and 5 local AEs. Plasma concentrations of cidofovir were very low (mean Cmax of 103.0 and 99.2 ng/mL after 5 and 10 hours of exposure, respectively). CONCLUSION: Cidofovir, directly applied on CIN 2+, is reasonably well tolerated and the systemic exposure following topical application is much lower than that seen with intravenous administration, at the approved dose.
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Optimizing the Histological Diagnosis of Adenomyosis Using in vitro Three-Dimensional Ultrasonography.

The use of in vitro three-dimensional ultrasound examination with needle stereotaxis after hysterectomy is illustrated in a case of extensive adenomyosis. The quality of the images at in vitro ultrasonography was compared with the quality of the images obtained at the preoperative ultrasound examination. The ultrasound findings were compared with the macroscopical and the microscopical examination. This new approach helps in indicating the precise location of the preoperatively identified adenomyosis lesions to the pathologist. This may optimize the diagnostic accuracy of the histological examination in women with adenomyosis.