Tenofovir alafenamide or tenofovir disoproxil fumarate in pregnancy to prevent HBV transmission: Maternal ALT trajectory and infant outcomes.

BACKGROUND: The use of antiviral agents, specifically tenofovir disoproxil fumarate (TDF), in pregnant women to prevent mother-to-child HBV transmission is a key step towards hepatitis elimination. However, data on using tenofovir alafenamide (TAF) is insufficient. The frequent occurrence of postpartum ALT flares may impact the clinical implementation. METHODS: The maternal and infant outcomes were compared in multi-centre trials of high viral load HBsAg/HBeAg+ pregnant women receiving TAF or TDF from the third trimester until 2 weeks postpartum with intensive follow-ups. To explore the dynamic pre- and postpartum changes in ALT levels, we used a group-based trajectory model for analysing data of 332 women from three prospective studies. RESULTS: After treatment, the maternal HBV DNA levels significantly decreased from baseline to delivery: 7.87 ± 0.59 to 3.99 ± 1.07 Log10 IU/mL TAF (n = 78) and 8.30 ± 0.36 to 4.47 ± 0.86 Log10 IU/mL (TDF, n = 53), with viral load reductions of 3.87 versus 3.83 Log10 IU/mL. The HBsAg-positive rates among 12-month-old infants were 1.28% (1/78) versus 1.82% (1/55) respectively (p = 1.00). Of the TAF or TDF-treated mothers, 25.64% versus 16.98% experienced ALT > 2X ULN, and 11.54% versus 1.89% received extended antiviral treatment. Our model revealed four distinct ALT patterns: stable ALT (87.2%), moderate (8.0%) or marked (2.4%) postpartum flares, or prepartum elevations (2.4%). CONCLUSIONS: TAF effectively reduces mother-to-child HBV transmission, but prophylaxis failure still occurred in few cases. Postpartum ALT flares are common in women receiving TAF or TDF during pregnancy. Approximately 12.8% of mothers may require extended postpartum antiviral treatment. CLINICAL TRIAL NUMBER: NCT03695029 (ClinicalTrials.gov).

The effect of the electronic platform of menopausal health screen system and counseling intervention on the empowerment of menopausal women: a quasi-experimental study.

This article explores the efficacy of the electronic platform of menopausal health screen system (EPMHSS) and counseling intervention on the empowerment of menopausal women, seventy four participants were randomly assigned to this study. The intervention group significantly relieved menopausal disturbance, reduced uncertainty, increased health behaviors, and decreased waist circumference after the fourth and eighth week compared with the control group. Our results proved that EPMHSS and counseling would help menopausal women to become more aware of their health, as a result, effectively empowered themselves to take actions for improving their health.

Application of Sentinel Lymph Node Technique to Transvaginal Natural Orifices Transluminal Endoscopic Surgery in Endometrial Cancer.

STUDY OBJECTIVE: This report outlines our first experience of sentinel lymph node (SLN) mapping in the natural orifices transluminal endoscopic surgery (NOTES) technique, which is the combination of the least invasive surgical approach and the least invasive way of assessing lymph node status. DESIGN: Descriptive study (Canadian Task Force classification III). SETTING: Tertiary referral and educational center. PATIENTS: Four patients with endometrial cancer clinical stage 1. INTERVENTIONS: NOTES with SLN mapping using an indocyanine green-based near-infrared fluorescence imaging technique. MEASUREMENTS AND MAIN RESULTS: The average operative time was 182.75 minutes (standard deviation, 34.5). Mean estimated blood loss was 67.5 mL (standard deviation, 39.4). All patients had surgical staging of International Federation of Gynecology and Obstetrics stage IA (pT1aN0). The overall detection rate and bilateral detection rate were 100% (4/4). All procedures were successfully completed without complication or conversion to conventional laparoscopy. CONCLUSION: In our preliminary experience, SLN mapping in NOTES surgery appears to be feasible and safe. It can be considered as an alternative method to reduce morbidity from radical lymphadenectomy and provide the benefits from the NOTES technique. However, studies in a larger population are necessary.

Novel Neovaginoplasty Using Rudimentary Uterine Horn Serosa and Pelvic Peritoneum as a Graft in Müllerian Anomalies with Vaginal Agenesis.

STUDY OBJECTIVE: To study the outcome of a novel method of laparoscopic neovaginal reconstruction using rudimentary uterine horn serosa and the pelvic peritoneum as a graft. DESIGN: Canadian Task Force classification II-1. SETTING: A university hospital. PATIENTS: A retrospective study of 14 patients from 2000 to 2014 of patients with vaginal agenesis who underwent laparoscopic neovagina reconstruction using rudimentary uterine horn serosa and the pelvic peritoneum as a graft. INTERVENTION: Patients with vaginal agenesis associated with müllerian agenesis who requested surgery. Tertiary referral center and laparoscopic unit. The creation of a neovagina using rudimentary uterine horn serosa and the pelvic peritoneum as a graft via a combined laparoscopic and vaginal route. MEASUREMENTS AND MAIN RESULTS: Data were collected retrospectively including postoperative vaginal length and width, complications, stenosis or reoperations, dyspareunia, and sexual satisfaction. There were no major complications from the surgery with no rectal perforation or bladder or ureteric injury. The postoperative mean (±SD) vaginal length was 6.0±0.7 cm and a width of 2 fingerbreadths. The mean operation time was 142.7±45.9 min. Median blood loss was 100 ml (range: 10 to 300 mL). The mean duration of the hospital stay was 6.6±1.6 days. The follow-up period ranged from 3 to 84 months with a median follow-up of 11 months. CONCLUSION: Lee's method of neovaginoplasty using rudimentary uterine horn serosa and the pelvic peritoneum as a graft is a good method for neovagina creation with minimal morbidity, fast recovery, and minimal complications. This method results in good anatomic and functional outcome and can be a method that is widely used.

Effectiveness and appropriateness in the application of office hysteroscopy.

With the advances in miniature instruments, office hysteroscopy on conscious patients has been the standard to explore the intrauterine pathology, with the ability to perform some minor procedures concomitantly. Patients usually appreciate the efficient "see and treat" procedures with such minimal discomfort that exempt from the inconvenience of going into the operating room and the need for anesthesia. However, controversies exist in the appropriateness of its application in some clinical situations. Concerns include (1) the criteria for hysteroscopy applied in the vast number of patients suffering from abnormal uterine bleeding or subfertility, and (2) the frequency for repeated hysteroscopy on some kinds of patients, such as those of endometrial cancer with fertility-sparing treatment for monitoring the disease, or those of severe intrauterine adhesion who need adhesiolysis for subsequent conception, in whom the appropriate protocol of repeatedly applying hysteroscopy lacks consensus. This article reviews the literature to find the best available evidence on the effectiveness of office hysteroscopy in comparison with other clinical diagnostic tools, as well as the current opinions on such controversies in its application.

The Power Law of Learning in Transumbilical Single-Port Laparoscopic Subtotal Hysterectomy.

STUDY OBJECTIVE: To analyze the surgical outcomes and learning curve of transumbilical single-port laparoscopic subtotal hysterectomy, which requires sutures of the cervical stump. DESIGN: A prospective observational study (Canadian Task Force classification II-2). SETTING: A university-affiliated center. PATIENTS: From the first (July 2012) and consecutive patients of benign uterine disease scheduled for subtotal hysterectomy until October 2013. INTERVENTIONS: All single-port laparoscopies were performed using straight instruments by 1 gynecologist. An ancillary port was added whenever technical difficulties could endanger surgical quality. MEASUREMENT AND MAIN RESULTS: Seventy-five patients were recruited for intention-to-treat analysis with a mean (±SD) age of 44.7 ± 3.8 years and a body mass index of 24.2 ± 3.7 kg/m2. No major complication was noted. The mean uterine weight was 432.5 ± 344.0 g with 24 (32%) uteri ≧500 g. The patients' sequential order, or gradually increasing experience, was the determining factor in progressively decreasing operative time. Furthermore, most cases that required an additional ancillary port (67%) were clustered in the first 20 cases, whereas 4 were scattered after the 47th patient because of severe pelvic adhesion. The mean operative time decreased in the power law function of the patients' sequential order with a plateau achieved at the 20th patient. CONCLUSION: The patients' sequential order was identified as an independent factor of achieving purely single-port access, and the trend of decreasing operative time delineated the existence of a learning curve. Approximately 20 patients were needed for an experienced multiport laparoscopist to reach technical competency in the current series.

Efficacy of maternal tenofovir disoproxil fumarate in interrupting mother-to-infant transmission of hepatitis B virus.

UNLABELLED: The efficacy and safety of maternal tenofovir disoproxil fumarate (TDF) in reducing mother-to-infant hepatitis B virus (HBV) transmissions is not clearly understood. We conducted a prospective, multicenter trial and enrolled 118 hepatitis B surface antigen (HBsAg)- and hepatitis B e antigen-positive pregnant women with HBV DNA ≥7.5 log10 IU/mL. The mothers received no medication (control group, n = 56, HBV DNA 8.22 ± 0.39 log10 IU/mL) or TDF 300 mg daily (TDF group, n = 62, HBV DNA 8.18 ± 0.47 log10 IU/mL) from 30-32 weeks of gestation until 1 month postpartum. Primary outcome was infant HBsAg at 6 months old. At delivery, the TDF group had lower maternal HBV DNA levels (4.29 ± 0.93 versus 8.10 ± 0.56 log10 IU/mL, P < 0.0001). Of the 121/123 newborns, the TDF group had lower rates of HBV DNA positivity at birth (6.15% versus 31.48%, P = 0.0003) and HBsAg positivity at 6 months old (1.54% versus 10.71%, P = 0.0481). Multivariate analysis revealed that the TDF group had lower risk (odds ratio = 0.10, P = 0.0434) and amniocentesis was associated with higher risk (odds ratio 6.82, P = 0.0220) of infant HBsAg positivity. The TDF group had less incidence of maternal alanine aminotransferase (ALT) levels above two times the upper limit of normal for ≥3 months (3.23% versus 14.29%, P = 0.0455), a lesser extent of postpartum elevations of ALT (P = 0.007), and a lower rate of ALT over five times the upper limit of normal (1.64% versus 14.29%, P = 0.0135) at 2 months postpartum. Maternal creatinine and creatinine kinase levels, rates of congenital anomaly, premature birth, and growth parameters in infants were comparable in both groups. At 12 months, one TDF-group child newly developed HBsAg positivity, presumably due to postnatal infection and inefficient humoral responses to vaccines. CONCLUSIONS: Treatment with TDF for highly viremic mothers decreased infant HBV DNA at birth and infant HBsAg positivity at 6 months and ameliorated maternal ALT elevations. (Hepatology 2015;62:375-386.

Pattern Recognition to Prognosticate Endometrial Cancer: The Science Behind the Art of Office Hysteroscopy-A Retrospective Study.

OBJECTIVE: This study aimed to evaluate a specific glomerular pattern for prognostication of endometrial cancer (EC). MATERIALS AND METHODS: The office hysteroscopy's picture and video of 4197 women were reviewed, 48 women who were suspected of type I EC were analyzed: 26 have glomerular pattern (group 1) and 22 without it (group 2). RESULTS: The histopathological grading after hysterectomy with glomerular pattern had grade 2 or grade 3 disease on final histology (n = 25; 96%). The sensitivity and specificity of this test were 84.6% and 81.8%, respectively, with a likelihood ratio of 4:6 in predicting and prognosticating those women who have high-grade tumor or invasive disease. CONCLUSIONS: This hysteroscopic picture might be used as a novel marker for risk stratification of EC.

[Developing and Verifying the Validity and Reliability of the Electronic Menopausal Health Screen System].

BACKGROUND: Menopausal women are in a transitional phase between health and sickness. Although the highest standards of menopausal care include clinical assessment and patient education on menopausal symptoms, current practices lack integrated care that aim to prevent chronic diseases for which menopause is a predisposing factor. PURPOSE: To integrate menopausal disturbances; to evaluate the risk factors for osteoporosis, cardiovascular disease, and diabetes; and to create a reliable and effective electronic menopausal health screen system (EMHSS). METHODS: The research was conducted in the four stages of assessment and analysis, design, development, and pretest stage in order to explore the effectiveness of the developed EMHSS. RESULTS: The EMHSS has a high degree of reliability and validity. Analysis found an expert validity of .97~.99, content validity of .99, and test-retest reliabilities of .80~.96 (Pearson's correlation) and .79~.96 (intra-class correlation). CONCLUSIONS / IMPLICATIONS FOR PRACTICE: The EPMHSS was developed using cross-disciplinary collaboration among nursing staff, medical practitioners, and information engineers in order to screen menopausal women. The EPMHSS provides tailored health education content for patients in a timely manner and compiles historical assessment data that may be referenced by nursing staff when providing health consultations and by physicians when delivering diagnoses and treatment.

Gonadotropin-releasing hormone type II (GnRH-II) agonist regulates the motility of human decidual endometrial stromal cells: possible effect on embryo implantation and pregnancy.

Invasion of the maternal decidua by extravillous trophoblast is an important process for embryo implantation and placentation in humans. Motile behavior of decidual endometrial stromal cells has been considered of critical importance for embryo implantation and programming of human pregnancy. The gonadotropin-releasing hormone (GnRH) effects in endometrium have raised concerns in reproduction. In the present study, we examined the action of GnRH-II agonist-promoted motility of human decidual endometrial stromal cells and the mechanisms of the action, indicating the role of GnRH-II agonist in embryo implantation and early pregnancy. Human decidual endometrial stromal cells were isolated from the decidual tissue from healthy women undergoing elective pregnancy termination of a normal pregnancy at 6- to 12-wk gestation, after informed consent. Cell motility was estimated by invasion and migration assay. Zymography and immunoblot analysis were performed to investigate the mechanisms of the GnRH-II action. The GnRH-I receptor (GnRH-IR) was expressed in human decidual tissue and endometrial stromal cells. The GnRH-II agonist promoted cell motility. Mitogen-activated protein kinase inhibitors abolished GnRH-II agonist-induced cell motility and activation of MMP-2 and MMP-9. GnRH-II agonist-mediated cell motility was suppressed by knockdown of endogenous GnRH-IR, MMP (matrix metalloproteinase)-2, and MMP-9 with small interfering RNA and MMP inhibitors. Our study demonstrates that the GnRH-II agonist promoted the cell motility of human decidual endometrial stromal cells through the GnRH-IR and the phosphorylation of extracellular signal-regulated protein kinase 1/2 and JNK-dependent activation of MMP-2 and MMP-9. Our findings represent a new concept regarding the mechanisms of GnRH-II-promoted cell motility, suggesting that GnRH-II agonist has strong effects on embryo implantation and decidual programming of human pregnancy.