Importance of human papillomavirus vaccination leaflets focusing on the safety profile targeted pediatricians in Japan.

OBJECTIVES: To investigate the association between providing leaflets to support pediatricians in explaining the safety of the human papillomavirus (HPV) vaccine and mother's decision to vaccinate their daughters in Japan. METHODS: In this cross-sectional study, we conducted a survey of mothers to evaluate the effect of leaflets that were created to support pediatricians in explaining the safety profile of the HPV vaccine. Mothers who provided consent for vaccination before receiving an explanation were excluded from the study. The primary outcome was the mother's decision to vaccinatetheir daughters with the HPV vaccine after receiving an explanation from pediatricians using our leaflets. RESULTS: Among 161 eligible mothers, 101 decided on HPV vaccination (decided group) and 60 did not (decided against group). There was no difference in the maternal background between the 2 groups. The decided group had a significantly more positive impression of the leaflets than the undecided group. In multivariable logistic regression analysis, a detailed explanation for possible adverse events and specific solutions to them was associated with the mother's decision to have their daughters vaccinated (odds ratio 2.35, 95% confidence interval 1.02-5.44), but not the pathology of cervical cancer and the HPV vaccination process. CONCLUSION: Leaflets emphasizing an explanation of adverse events may contribute to mothers' decision making for HPV vaccination.

Outcome of the fetuses with severely increased nuchal translucency thickness in the first trimester.

AIM: To study the outcome of pregnancies with severely increased nuchal translucency (NT) thickness at the 11-13-week scan. METHODS: This study included 162 singleton pregnancies whose fetuses had increased NT thickness ≥ 5.5 mm between September 2013 and August 2018. The cases were divided into two groups: NT ≥ 6.5 mm (n = 112) (group A); and 6.5 mm > NT ≥ 5.5 mm (n = 50) (group B). Fetal (amniotic fluid) or placental (chorionic villous) chromosome analyses were conducted. Subsequent ultrasound findings, pregnancy outcome and structural defects in the neonates were recorded and analyzed. RESULTS: Abnormal karyotype was found in 71% (60/84) (group A) and 57% (21/37) (group B) of the cases respectively. In group A, 15 cases out of 24 with normal karyotype were born. Among these 15 cases, one case died soon after birth and 5 cases had associated abnormalities. In group B, 13 cases out of 18 with normal karyotype or negative noninvasive prenatal testing results and 1 case out of 2 cases with 47,XXY were born. All of them survived with no major anomaly. CONCLUSION: Incidence of chromosomal aberrations was high in the cases with severely increased NT thickness. But favorable outcome could be expected if the fetus had no chromosomal abnormality and no abnormal findings were found in second trimester ultrasound scan especially in a fetus with increased NT < 6.5 mm.

Effectiveness of mobile application for menstrual management of working women in Japan: randomized controlled trial and medical economic evaluation.

AIMS: Hormonal imbalances can affect a woman's physical and mental condition, impacting her daily life and productivity. A mobile application, "Karada-no-kimochi", predicts the menstrual cycle based on recorded data, and provides the information regarding menstruation. This study investigates the effectiveness of the application from health condition and labor productivity loss perspectives, and evaluates its cost-effectiveness for employed women in Japan. MATERIALS AND METHODS: A randomized controlled trial (RCT) was performed to compare the use of the application and non-intervention in female workers (20-45 years) based on an online survey. A discrete-event model based on the RCT data, published literature, and claims data was used for the cost-effectiveness analysis. RESULTS: The intervention and non-intervention groups comprised 612 and 914 women, respectively. In the intervention group, the incidences of depression (0.16%) and dysmenorrhea (0.33%) were significantly lower than those of the non-intervention group (0.77% and 1.31%, respectively) in the third month. While labor productivity and absenteeism varied, presenteeism showed almost no change across groups. The quality-adjusted life year in the intervention group was 6.84 (0.07 higher than that in the non-intervention group). By analyzing medical expenses and making assumptions regarding productivity, we estimated that the aggregate of medical expenses, productivity loss, and application fee for the intervention group could be lower than that of the non-intervention group by over JPY 130,000 (USD 1,170, as of December 2017) per individual. LIMITATIONS: The subjects included were willing or relatively willing to use the application. Because all outcomes were based on online surveys, the results depended on the objectivity and preciseness of the reports provided by users, and those with severe symptoms might not provide reports. CONCLUSIONS: The results suggest that using the application is cost-effective and might reduce the incidence of dysmenorrhea and depression.

Association between sexual health and delivery mode.

INTRODUCTION: Female sexual function changes considerably during pregnancy and the postpartum period. In addition, women's physical and mental health, endocrine secretion, and internal and external genitalia vary during these times. However, there are limited studies on the relationship between delivery and sexual function. AIM: The present study aimed to demonstrate the association between sexual function and delivery mode. METHODS: Mothers who delivered a single baby at term were recruited for the study, and 435 mothers were analyzed. MAIN OUTCOME MEASURES: The Female Sexual Function Questionnaire (SFQ28) scores and mothers' backgrounds were assessed at 6 months after delivery. RESULTS: The delivery mode affected the SFQ28 partner domain. Episiotomy affected the arousal (sensation) domain. Multiple regression analysis revealed that maternal age and cesarean section were significantly associated with several SHQ28 domains. CONCLUSION: This study suggests that routine episiotomies at delivery should be avoided to improve postpartum maternal sexual function. Maternal age and cesarean section were found to affect postpartum sexual health.

Laxity of the vaginal introitus after childbirth: nonsurgical outpatient procedure for vaginal tissue restoration and improved sexual satisfaction using low-energy radiofrequency thermal therapy.

INTRODUCTION: Vaginal childbirth may result in vaginal introital laxity, altered genital sensation during sexual intercourse, and reduced sexual satisfaction. We report the long-term effectiveness of a single nonsurgical procedure with radiofrequency (RF) energy for laxity at the vaginal introitus. MATERIALS AND METHODS: Prospective single-arm study of 30 premenopausal women (21-52 year) with one 30-minute office procedure using RF applied to the vaginal introitus; 12-month outcome assessments included the linguistic validated Japanese versions of the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R) and the Vaginal Laxity and Sexual Satisfaction Questionnaires. RESULTS: Sexual function improved significantly throughout 6 months (30 subjects); mean FSFI total score was 22.4±6.7 before treatment and then improved to mean 26.0±5.8 at month 6 (P=0.002), inclusive of improved scores in five of six FSFI domains except desire (P<0.001 -<0.01). In the 22 of 30 subjects remaining evaluable at 12 months, the mean was 26.0±5.2 (P=0.08). Distress related to sexual activity decreased significantly; baseline FSDS-R mean score of 15.8±11.7 improved to 9.8±8.0 at one month and was sustained throughout 12 months (P<0.001 - 0.002). Subjects reported decreased vaginal laxity within the first month after the procedure (P<0.001); responses peaked, and effectiveness was sustained through 12 months (P<0.001). CONCLUSIONS: A single nonsurgical office-based RF procedure for vaginal introital laxity achieved significant and sustainable 12-month effectiveness with respect to improved integrity at the vaginal introitus and improved sexual satisfaction. Treatment was well-tolerated with no adverse events.

Relationship between human tumor-associated antigen RCAS1 and gestational diabetes mellitus.

PROBLEM: The human tumor-associated receptor-binding cancer antigen expressed on SiSo cells (RCAS1) is considered to play a role in the inhibition of the maternal immune response during pregnancy. The aim of our study was to investigate the expression of RCAS1 protein in the placenta and to compare its concentration in maternal and cord blood sera between normal pregnancies and pregnancies complicated by gestational diabetes mellitus (GDM). METHOD OF STUDY: Samples were obtained from women with GDM (n = 8), women with type 1 DM (n = 5), and healthy term controls (n = 27) after delivery. Placentas were studied by immunohistochemistry, and real-time polymerase chain reaction. For assessment of RCAS1 concentrations in maternal and cord blood sera, enzyme-linked immunosorbent assay was performed. RESULTS: The RCAS1 protein mRNA expression in the placentas of patients with GDM was significantly lower than that in the controls (P = 0.005). The maternal blood RCAS1 protein concentration of the GDM cases was also significantly lower than that in the controls (P = 0.0411), whereas the cord blood RCAS1 protein concentration was significantly higher in the GDM and type 1 DM groups than in the controls (P = 0.0311 and P = 0.0192, respectively). CONCLUSION: The present results suggest that RCAS1 protein might have an important role in the development of GDM.

Level of S100B protein expression in the amnion at various gestational ages in the third trimester of normal pregnancies.

BACKGROUND: S100B protein is a unique calcium-binding protein. Its biological role within the cell populations is not completely defined. Some pathological conditions that develop during pregnancy could affect S100B concentrations in the amniotic fluid, cord blood, and maternal serum. The aim of our study was to assess the correlation between S100B protein expression in the amnion, amniotic fluid and gestational age in the third trimester of uncomplicated pregnancies. METHODS: Amnion, amniotic fluid, maternal peripheral and umbilical cord blood samples were collected from healthy women who delivered at 31-36 weeks (n=17), 37-40 weeks (n=22), and 41-42 weeks (n=21). The expression of S100B in the amnion was assessed by immunohistochemistry and real-time (RT)-PCR, and its concentrations in amniotic fluid, maternal and cord blood sera were determined by ELISA. RESULTS: The S100B protein expression in the amnion and its concentrations in amniotic fluid, maternal and cord blood sera of patients in the third trimester were not significantly different at various gestational ages. CONCLUSIONS: The S100B protein expression in the amnion and the S100B protein concentrations in amniotic fluid, maternal and cord blood do not vary significantly in the third trimester of uncomplicated pregnancies.

Immunisation of male mice with a plasmid DNA vaccine encoding gonadotrophin releasing hormone (GnRH-I) and T-helper epitopes suppresses fertility in vivo.

Immunisation against mammalian gonadotrophin releasing hormone (GnRH-I) linked to large carrier proteins has been shown to disrupt fertility. However, various studies have shown that the carrier protein causes epitope suppression of the hapten response, resulting in short-lived immunoneutralisation, followed by a return of fertility. A range of strategies has been used to resolve this, with limited success. The aim of this study was to construct a plasmid DNA vaccine encoding GnRH-I and T-helper epitopes. A 498 bp long vaccine construct in pcDNA3.1+ was administered to male mice in conjunction with a Hemagglutinating Virus of Japanese Envelop (HVJ-E) vector or in saline solution. The vaccine efficacy was evaluated in terms of GnRH-I specific IgG antibody response, serum testosterone levels, testicular spermatogenesis and the ability to produce offspring. The vaccine appeared to induce higher anti-GnRH-I IgG antibody response and insult the fertility axis, which was characterised by a drop of epididymal sperm counts, reduction of serum testosterone levels, suppressed testicular spermatogenesis and a significant decrease in litter numbers compared to control animals. The end-point vaccine efficacy was much higher in the HVJ-E vector mediated immunisation, than in saline alone.

Post-ischemic hypothermia reduced IL-18 expression and suppressed microglial activation in the immature brain.

Inflammation is an important factor for hypoxia-ischemia (HI) brain injury. Interleukin (IL)-18 is a proinflammatory cytokine which may be a contributor to injury in the immature brain after HI. To investigate the effects of post-HI hypothermia on IL-18 in the developing brain, 7-day-old rats were subjected to left carotid artery ligation followed by 8% oxygen for 60 min and divided into a hypothermia group (rectal temperature 32 degrees C for 24 h) and a normothermia group (36 degrees C for 24 h). The IL-18 mRNA was analyzed with real-time RT-PCR, and the protein level was analyzed by Western blot, and the location and source of IL-18 were assessed by immunohistochemistry. The significant increase of the IL-18 mRNA was observed in the ipsilateral hemispheres of the normothermia group at 24 h and 72 h after HI compared with controls, but the level in the ipsilateral hemispheres of the hypothermia group was significantly reduced at both time points, compared with the normothermia group, respectively. The IL-18 protein level in the ipsilateral hemispheres of the normothermia group significantly increased at 72 h after HI compared with controls, however, the protein level of the hypothermia group was significantly decreased, compared with the normothermia group. IL-18-positive cells were observed throughout the entire cortex, corpus callosum (CC) and striatum in the ipsilateral hemispheres of normothermia group at 72 h after HI, however, little positive cells were observed in the hypothermia group. Double labeling immunostaining found that most of the IL-18-positive cells were colocalized with lectin, which is a marker of microglia. The number of ameboid microglia (AM) in the normothermia group was significantly increased in cortex and CC, compared with the number in controls, but there were very few ramified microglia (RM) in these areas. In contrast, the number of AM in the hypothermia group was significantly decreased in cortex and CC, compared with the number in the normothermia group, and there were no significant differences in the number of AM and RM between the hypothermia group and controls. In conclusion, we found that IL-18 mRNA and the protein level were attenuated by post-HI hypothermia and that post-HI hypothermia may decrease microglia activation in the developing brain.