Safety and efficacy comparison of two dosing regimens of MetroGel-Vaginal® in the treatment of bacterial vaginosis: a multicenter,randomized, single-blind,parallel comparison

Objective: To compare the safety and efficacy of 0.75% metronidazole vaginal gel (MGV) administered QD for 5 days to MGV administered BID for 5 days for the treatment of bacterial vaginosis (BV).Methods: Nonpregnant women 18 years or older with a diagnosis of BV were enrolled into this trial. Patients were determined to have BV if their vaginal discharge had ≥20% clue cells and if they had at least 2 of the following criteria: homogeneous discharge, positive KOH amine odor test, or vaginal pH ≥4.7. In addition, microbiologic confirmation of BV at baseline was required to be evaluable. Patients were evaluated at baseline and at 7–12 days after completion of therapy. If patients remained free of BV after therapy, they were evaluated at a follow-up visit 28–35 days after therapy.Results: A total of 514 patients were enrolled in the trial; 252 in the QD treatment group and 262 in the BID treatment group. Clinical cure rates based on patients considered evaluable at first return visits were 77% and 80% for QD and BID dosing regimens, respectively. Clinical cure rates based on patients considered evaluable at the final visit were 58% and 61% for QD and BID dosing regimens, respectively. Clinical cure rates at the final return visit based on intent-to-treat analysis were 53% and 57% for the QD and BID regimens, respectively. Two adverse events in two patients were reported as serious. Both adverse events resolved and neither event was judged to be related to therapy.Conclusion: MetroGel-Vaginal administered QD for 5 days was found to be as effective as MetroGel-Vaginal administered BID for 5 days in the treatment of bacterial vaginosis 28–35 days after therapy. The number of patients reporting adverse events judged to be related to therapy was also statistically comparable in both treatment groups.     

Influence of Peripartum Expectations,Mode of Delivery,and Perineal Injury on Women’s Postpartum Sexuality

BackgroundSexual health has been identified as an important factor for postpartum quality of life. Although pregnancy-related changes in anatomy and metabolism return to their prepregnancy state, female sexual function may not be at the level it was before birth because of physical and psychological changes.AimThe goal of our study was to explore the influence of the mode of delivery, perineal injury, and peripartum expectations on postpartum sexual function.MethodsBetween 2013 and 2018, 522 women were enrolled in this prospective investigation. At time of recruitment during the peripartum hospitalization, patients completed a standardized questionnaire addressing expectations concerning postpartum sexuality with focus on expected influence of the mode of delivery. Sexual function was evaluated using the Female Sexual Function Index (FSFI) and Sexual Activity Questionnaire (SAQ) at time of recruitment to evaluate baseline sexual function (4 weeks before pregnancy). Follow-up assessments were conducted at 3, 6, and 12 months postpartum.OutcomesPeripartum expectations, influence of the mode of delivery, and perineal injury were analyzed for their impact on women’s sexual function within 12 months postpartum by repetitive FSFI and SAQ assessments.ResultsA total of 522 women with 263 spontaneous vaginal deliveries, 41 operative vaginal deliveries, and 218 cesarean sections were analyzed. Although the data demonstrate a significant postpartum decline in sexual function at 3 and 6 months postpartum, sexual functioning converges to baseline prepregnancy values 12 months postpartum. This observation was independent of the mode of delivery and perineal injuries with no significant between-group differences at any of the analyzed time points. Apart from breastfeeding, for which negative anticipations resulted in impaired sexuality, women’s expectations (pertaining to quantity and quality of female orgasm, partner’s sexuality, fear of altered sexuality, frequency of intercourse, the mode of delivery) do not influence female sexual function at 12 months postpartum.Clinical ImplicationsDeciphering the potential influence of patient expectations as well as pregnancy- and childbirth-related aspects on female postpartum sexuality will help in the effort to improve women’s postpartum sexual health.Strengths & LimitationsAs a strength of this study, postpartum sexuality was independently assessed with 2 different scoring systems (FSFI and SAQ). Limitations include that our follow-up is incomplete and amounts to about 2-thirds of patients who were initially recruited.ConclusionThe mode of delivery and perineal trauma do not influence women’s postpartum sexual function. With the exception of breastfeeding, peripartum expectations do not result in altered sexual functioning at 12 months postpartum.Spaich S, Link G, Alvarez SO, et al. Influence of Peripartum Expectations, Mode of Delivery, and Perineal Injury on Women’s Postpartum Sexuality. J Sex Med 2020;17:1312–1325.     

Networks of E-cadherin, β1 integrin,and focal adhesion kinase in the pathogenesis of tubal pregnancy

E-cadherin, β1 integrin, and focal adhesion kinase (FAK) are reported to involved in eutopic implantation by mediating cell adhesion. However, less is documented about their roles in ectopic implantation. This study was undertaken to evaluate the roles and networks of E-cadherin, β1 integrin, and FAK in tubal pregnancy. A total of 31 Fallopian tube specimens were obtained from tubal pregnant women. Immunohistochemistry and western blot were used to analyze the distributions and levels of E-cadherin, β1 integrin and phosphorylated-FAK (Pho-FAK) in the Fallopian tube epithelium. Normal Fallopian tube samples derived from non-pregnant women with benign genital diseases were used for comparison. E-cadherin presented in the cytomembrane of tubal epithelial cells and β1 integrin mainly expressed in the cytoplasm. A lowest-level of E-cadherin was detected in the implantation site (0.63?±?0.29) when compared with the non-implantation site (0.95?±?0.37) and the controls (0.89?±?0.33) (P?<?0.05). β1 integrin, as well as Pho-FAK in the implantation site (0.81?±?0.35; 0.72?±?0.24), showed a higher-level than that in the non-implantation site (0.59?±?0.26; 0.48?±?0.27) or the control group (0.38?±?0.19; 0.36?±?0.25) (p?<?.05). The decreased E-cadherin and increased β1 integrin are implicated in tubal pregnancy. The involvement of β1 integrin maybe depends on β1 integrin/FAK signaling.     

Cycle control,tolerability, efficacy and acceptability of the vaginal contraceptive ring,NuvaRing®: Results of clinical experience in Germany

Objectives To investigate the real-life clinical experience of NuvaRing® users in Germany.

Methods An open-label, prospective, uncontrolled, non-randomized, multicentre post-marketing surveillance study was conducted by 1204 gynaecologists amongst 5823 women requesting contraception. The women underwent routine examinations and contraceptive counselling, and were assessed after three and six cycles of NuvaRing® use.

Results: Good cycle control was observed and there was a reduction in cycle irregularity and inter-menstrual bleeding, bleeding duration and intensity, and dysmenorrhoea. NuvaRing® was well tolerated, and had no significant effect on body weight or blood pressure. Nine women became pregnant unintentionally (two had conceived before they started to use NuvaRing®, three due to non-compliance, one because of repeated ring expulsion/loss and three during treatment in spite of having applied this latter as instructed). Most women expressed their satisfaction with NuvaRing®; 82% were ‘very satisfied/satisfied’, 72% planned to continue using it and 82% would recommend it to others. More than 90% of women found NuvaRing®‘without problems/easy’ to insert and to remove, and more than 80% of the women and their partners were not disturbed by its presence during intercourse.

Conclusion: NuvaRing® is a highly effective and acceptable method of once-monthly contraception that is safe and well tolerated.     

The significance of clinical symptoms of subchorionic hematomas, “bleeding first”, to stratify the high-risk subgroup of very early preterm delivery

ObjectiveTo investigate the factors that stratify high-risk cases among subchorionic hematomas (SCHs) patients with persistent vaginal bleeding in early pregnancy.Materials and methodsA total of 56 patients who required hospitalization for SCH with vaginal bleeding in early pregnancy were classified into two groups: 1) no hematoma by ultrasonography when vaginal bleeding occurred, and then hematoma was observed by ultrasonography “bleeding to hematoma (BH group, n = 15)” and 2) no vaginal bleeding when hematoma was observed by routine ultrasonography, and then vaginal bleeding occurred later “hematoma to bleeding (HB group, n = 41)”. Retrospective cohort study was performed and maternal and neonatal outcomes were evaluated.ResultsThe duration of SCHs and/or vaginal bleeding was significantly longer in the BH group than in the HB group (mean: 60.8 days [BH group] vs. 33.3 days [HB group], p = 0.015). BH group patients delivered earlier than HB group patients significantly (mean: 27.3 weeks [BH group] vs. 35.6 weeks [HB group], p = 0.0028). The frequency of chronic abruption and oligohydramnios sequence (CAOS) was significantly higher in the BH group than in the HB group (3/15; 20.0% [BH group] vs. 0/41; 0.0% [HB group], p = 0.016). The frequency of sever fetal distress (Apgar score <4 points) was significantly higher in the BH group than in the HB group (4/15; 26.7% [BH group] vs. 0/41; 0.0% [HB group], p = 0.0037). The levels of factor XIII were relatively lower in the BH group than in the HB group (mean: 54.8% (n = 4) [BH group] vs. 76.1% (n = 7) [HB group], p = 0.077).ConclusionThe order of the symptoms, bleeding first, is an important feature that reflects the subsequent prolonged duration of SCHs/vaginal bleeding, resulting in very early preterm delivery. Continuous hemorrhage consumes coagulation factor XIII, which further worsen the hemostasis.     

Birth-related,psychosocial, and emotional correlates of positive maternal–infant bonding in a cohort of first-time mothers

Objective

to describe the development of a shortened 10-item version of the Postpartum Bonding Questionnaire (S-PBQ) and examine the relationship between birth-related, psychosocial, and emotional factors and maternal–infant bonding.

Design

cross-sectional interview study.

Setting

women having their first baby in Pennsylvania, USA.

Participants

we interviewed 3005 women in their third trimester and at one month post partum who were enroled in the First Baby Study.

Measurements and findings

for the S-PBQ, we completed factor analysis and examined instrument properties. We examined the relationship between birth-related, psychosocial, and emotional factors and maternal–infant bonding using adjusted linear regression models. The S-PBQ demonstrated acceptable internal reliability (Cronbach?s α=0.67). Analysis revealed a socio-economic bias such that women who were older, more educated, not living in poverty, and married reported lower bonding scores. Maternal–infant bonding was significantly negatively correlated with maternal stress, maternal pain, and post partum depression, and positively correlated with partner support with the infant, and social support.

Key conclusions and implications for practice

For researchers who wish to measure maternal–infant bonding but are in need of a relatively short scale, the 10 item S-PBQ may be a useful alternative to the original version. However, it is important that researchers measuring maternal–infant bonding also investigate socio-economic bias in their studies and adjust for this effect as needed. Our results also indicate that clinicians should be aware of life stressors that may impact the maternal–infant relationship, in order that intervention may be provided to improved health outcomes for mothers, infants, and families.     

The analysis of twin pregnancy and labour in the Department of Obstetrics, Medical Academy, Gdańsk

OBJECTIVES: According to the literature the frequency of twins is increasing due to technics af assisted reproduction. Many complications of pregnancy and delivery are more likely to develop during multiple pregnancy. DESIGN: Aim of the study was to analyze labour and delivery in multiple pregnancy and assess the neonate's condition. MATERIALS AND METHODS: Authors analyzed labour and delivery and neonate's condition in twin pregnancies in Medical University of Gdansk, Poland in 1991-1995 with birth weight at least 1000g. We assessed women's age, fetuses presentation, week of pregnancy at the delivery, mode of delivery, Apgar score, weight and crown-rump length after birth and early neonatal period. RESULTS: Mean age of pregnant women was 30.0 years (18-43). Mean birth weight for the first fetus was 2412 + 601 g and for the second one--2485 + 630 g. Mean SI for the first fetus was 49.8 + 4.4cm, for the second one--50.0 + 4.15 cm. Apgar core was analyzed separately for the first and the second twin according to the presentation and mode of delivery--we found better condition of the second babies delivered from transverse presentation by the cesarean section comparing to those born vaginally. 73% of the pregnancies with the first fetus in the cephalic presentation were delivered vaginally, in other situations--cesarean section was preferred. CONCLUSIONS: At the transverse presentation of the second twin elective cesarean section seems better for the second twin.