Comparison of perianal skin barrier function with moisturizer application in Japanese full-term newborns.

BACKGROUND/OBJECTIVES: Some full-term newborns present with erythema and irritation of the buttocks and perianal area as early as the first 4 days of their lives. The effect of moisturizers in protecting this vulnerable skin has not been rigorously studied. This study aimed to clarify whether there is a difference in perianal skin barrier function with and without moisturizer application in the first month of life. METHODS: Comparative investigation of 118 full-term newborns was performed, and they were allocated to intervention (n = 63) and control groups (n = 55). The intervention group received moisturizer application to the perianal area, and the control group received care without application of moisturizer to the perianal area from the first day of life until the 1-month visit. Transepidermal water loss (TEWL), stratum corneum hydration (SCH), and skin surface pH in the perianal area were measured as the indicators of skin barrier function on days 1 and 5 after birth and at the 1-month visit. RESULTS: At the 1-month visit, TEWL was significantly decreased (intervention, 19.4 g/m2 /h; control, 25.8 g/m2 /h; p = .00) and SCH was significantly increased (intervention, 58.8 arbitrary units (a.u.); control, 46.5 a.u.; p = .00) in newborns using perianal moisturizer. The skin surface pH was not significantly different. CONCLUSIONS: The use of moisturizer was effective in protecting the skin barrier function of the perianal skin. Further investigations are needed to determine the effect on the frequency and extent of rashes in the perianal area.

The factor structure of "expectant mothers of concern" as perceived by midwives.

AIM: To clarify the factor structure of "expectant mothers of concern" for whom midwives anticipate difficulties in future childrearing. METHODS: The participants were 2633 midwives working at hospitals and clinics in Japan. Data were collected using a 108-item, five-point Likert scale questionnaire about the behaviors, appearance, and family relationships of the expectant mothers of concern to the nurses. Items with a mean equal to or greater than 4.0 were selected as items considered relevant to expectant mothers of concern by midwives. Exploratory factor analysis, confirmatory factor analysis, and further secondary factor analysis were conducted. RESULTS: The factor structure of the expectant mothers of concern as perceived by midwives comprised seven factors, including 23 items: "Suspected of being a victim of intimate partner violence," "Uneasy feeling about the expectant mother's marital relationship," "Perception that the expectant mother is conflicted about her pregnancy," "Uneasy feeling about the expectant mother's actions/behaviors concerning her medical checkups," "Engages in physically risky actions and behaviors," "Does not appear to be able to build relationships with children," and "Makes remarks that indicate possible bonding disorder" (goodness-of-fit index = 0.910, adjusted goodness-of-fit index = 0.879, comparative fit index = 0.939, and root mean square error of approximation = 0.070). Further, a secondary factor, "Expectant mothers who must urgently be connected to support," was extracted. CONCLUSIONS: The elucidation of the factor structure of the expectant mothers of concern could help midwives identify expectant mothers who may face difficulties in future childrearing.

Effect of pelvic floor muscle training program in reducing postpartum levator hiatus area in Japanese women: A prospective cohort study using three-dimensional ultrasonography.

AIM: To assess the effect of a pelvic floor muscle training (PFMT) program on postpartum levator hiatus area. METHODS: A prospective cohort study was conducted at a clinic in Japan. Training and control groups were recruited from outpatient pregnant women at two separate time periods. Only the training group underwent the PFMT program, including education for home PFMT, home PFMT, and follow-up instructions. Education for home PFMT was held by 1 month postpartum to acquire the correct contraction of the pelvic floor muscle. Home PFMT was prescribed between 1 and 5 months postpartum; during this period, follow-up instructions were provided to keep the women motivated. Before and after home PFMT, the levator hiatus area was measured using ultrasonography. RESULTS: In total, 44 women in the training group and 45 in the control group were analyzed. There were 36 women who reached a high adherence to three daily sets of home PFMT. The reduction in the levator hiatus area at rest was not statistically higher in the training group than that in the control group. For the subgroup with high adherence, the reduction in the area at rest was significantly higher by 4.43% in the training group than that in the control group (19.90% vs. 15.49%). CONCLUSIONS: Although the PFMT program did not significantly reduce the postpartum levator hiatus area at rest, performing at least three sets of home PFMT each day significantly reduced the levator hiatus area by 4.43%. CLINICAL TRIAL REGISTRATION: UMIN Clinical Trials Registry (ID; UMIN 000026188, Date; 17 February 2017).

A comparison of the bioequivalence of two formulations of epoetin alfa after subcutaneous injection.

BACKGROUND: The previous formulation of epoetin alfa in Japan was a citrate-buffered protein solution containing gelatin hydrolysate as the protein protective agent. To eliminate pain at injection sites, and the risks of anaphylactic shock and unknown infections by gelatin we have developed a new formulation of phosphate-buffered epoetin alfa, which does not contain gelatin hydrolysate. AIM: To compare the bioequivalence of two formulations of epoetin alfa administered by the subcutaneous route. METHODS: Four separate studies were performed to assess the bioequivalence of two epoetin alfa formulations using different strength and doses, i.e. 750 IU per 0.5 ml x 0.5 ml (= 750 IU per subject), 750 IU per 0.5 ml x 4 ml (= 6000 IU per subject), 6000 IU per 0.5 ml x 0.5 ml (= 6000 IU per subject) and 24,000 IU per 0.5 ml x 0.125 ml (= 6000 IU per subject). Each study was a single-centre, open-label, randomized, two-treatment, two-period, crossover study for which healthy volunteers were enrolled. Bioequivalence was assessed using the confidence interval (CI) of the ratios for the log-transformed, baseline-corrected Cmax and AUC(0,t). Baseline-corrected AUC(0,t) was calculated using the following equation: AUC(0,t) = AUC(0,t), uncorrected -- predose level x observation period. RESULTS: The ratios (gelatin-free/gelatin-containing) for the log-transformed Cmax and AUC(0,t) after 6000 IU per subject injection of three different concentrations of epoetin alfa were well within the usual range for bioequivalence (90% CI 0.8, 1.25). The 90% CI of the ratio for Cmax after 750 IU per subject injection was 0.906, 1.24, which was within the bioequivalence range. However, the ratio for AUC(0,t) was not determined in this lowest dose because of negative AUC(0,t) values obtained in 12/60 cases. The overall safety data were consistent with those expected for a healthy study population, and did not present any concerns suggestive of adverse effects due to either formulation. CONCLUSIONS: The point estimates and 90% CIs of the ratios of Cmax and AUC(0,t) for the gelatin-free/gelatin-containing formulations indicated that the two formulations are bioequivalent.