Effectiveness of degradable polymer film in the management of severe or moderate intrauterine adhesions (PREG-2): a randomized, double-blind, multicenter, stratified, superiority trial.

OBJECTIVE: To study the effectiveness of a new intrauterine degradable polymer film (Womed Leaf) in the management of moderate to severe intrauterine adhesions (IUA). DESIGN: PREG-2 study was a multicenter, double-blind, randomized, controlled, stratified, two-arm superiority clinical trial conducted in 16 centers in seven countries. SETTING: Not applicable. PATIENT(S): Patients ≥18 years scheduled for hysteroscopic adhesiolysis because of symptomatic severe or moderate adhesions (according to American Fertility Society [AFS] IUA score) were considered eligible for the study. INTERVENTION(S): After adhesiolysis, patients were randomized at a 1:1 ratio to either have a Womed Leaf film inserted (intervention group) or not (control group). MAIN OUTCOME MEASURE(S): The primary effectiveness endpoint of the study was the change in AFS IUA score on second-look hysteroscopy (SLH), assessed by an independent evaluator, and compared with baseline. Information on the rate of no IUA and responder rate was collected as secondary effectiveness outcomes, while reported adverse events and patient-reported outcomes as safety and tolerability measures. RESULT(S): Between October 26, 2021, and September 28, 2023, a total of 160 women were randomized (Womed Leaf: n = 75 and controls: n = 85). The reduction in IUA AFS score on SLH was significantly higher in the intervention compared with the control group (mean 5.2 ± 2.8 vs. 4.2 ± 3.2). Similarly, the absence of adhesions on SLH was significantly higher in the intervention group (41% vs. 24%; odds ratio, 2.44; confidence interval, 1.161-5.116). None of the reported adverse events were serious or considered related to the device. CONCLUSION(S): Womed Leaf is effective and safe in the management of symptomatic severe or moderate IUAs. CLINICAL TRIAL REGISTRATION NUMBER: Clinicaltrials.gov identifier: NCT04963179.

Office hysteroscopy for postmenopausal women: Feasibility and correlation with transvaginal ultrasound.

OBJECTIVE: To evaluate feasibility of office hysteroscopy in postmenopausal women and correlation between transvaginal ultrasound (TV-US) and hysteroscopy. METHODS: Postmenopausal women addressed at office hysteroscopy for postmenopausal bleeding or increase endometrial thickness were included. A 3.5-mm rigid hysteroscope was used without cervical dilatation or local anaesthesia. Speculum was never used. Data concerning women's symptoms and TV-US findings were collected. RESULTS: Four-hundred-seventy postmenopausal women referred for office hysteroscopy were included in this descriptive study. Three-hundred-fifty women (74.5%) experienced abnormal uterine bleeding. The success rate of office hysteroscopy was 76.4% and was significantly higher in cases of postmenopausal bleeding (80.9%) than in women without postmenopausal bleeding (63.3%) (p=0.01). Three-hundred-sixteen women had both a successful hysteroscopy and TV-US. The correlation between hysteroscopy and TV-US was 68.5% for the diagnosis of increased endometrial thickness, polyps and submucosal myoma (Kappa=0.28). The rate of endometrial cancer for women with postmenopausal bleeding was 12.6% (n=44) while it was 1.7% (n=2) for asymptomatic women. Two (4.3%) out of these 46 women with endometrial cancer had normal hysteroscopy, while 7 (15.2%) had a normal TV-US (including endometrial thickness below 5mm). Among the 54 women without bleeding and with a thickened endometrium, one (1.8%) had endometrial cancer. CONCLUSION: Office hysteroscopy is successful without anaesthesia for 76.4% of postmenopausal women. The correlation between TV-US and hysteroscopy is low, and we recommend to practice both sonography and hysteroscopy in women with postmenopausal bleeding.

Clinical presentation and outcome of 20 fetuses with parvovirus B19 infection complicated by severe anemia and/or fetal hydrops.

AIM: The aim of this study was to assess the prognosis of parvovirus B19 infection with severely anemic and/or hydropic fetuses according to initial ultrasound and biological criteria. MATERIAL AND METHODS: Retrospective study of 20 cases of congenital parvovirus B19-proven infection (positive PCR) complicated by fetal anemia and/or hydrops was examined. Anemia was suspected on an elevated peak systolic velocity of the middle cerebral artery and was confirmed by fetal blood sampling. RESULTS: Survival rate was 70% (14/20) overall and 76% (13/17) for fetuses with one or more transfusions. When fetal effusion regressed after the transfusion, all 11 fetuses survived, and neonatal condition was favorable for all. Among the 14 live-born children, there was one neonatal death and one admission to the neonatal care unit with no major complications. CONCLUSION: Despite active management by transfusion in fetuses with parvovirus B19 infection, mortality remained substantial during the acute phase of anemia and fetal hydrops. Regression of effusion appears to be an important variable for prognosis. Non-anemic forms exist with isolated refractory ascites or pleural effusion. Maternal mirror syndrome appears to reflect the intensity and persistence of the fetal anemia.