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The article focuses on a case involving a 38-year-old woman who presented with sudden-onset voiding dysfunction, vaginal pain, and a protruding vaginal mass after sneezing. Topics include the diagnostic process of identifying a thrombosed lesion and ureterocele, the treatment and management involving drainage and further imaging, and the patient's outcome after successful decompression and follow-up cystoscopy.

The article discusses a case of a 76-year-old woman who developed iatrogenic Cushing syndrome and secondary adrenal insufficiency from using a compounded mouthwash containing clobetasol propionate, a potent corticosteroid. The patient experienced symptoms such as fatigue, weight loss, and bruising, leading to a diagnosis of secondary adrenal insufficiency. Treatment involved transitioning from the magic mouthwash to a steroid-sparing agent and oral hydrocortisone therapy, resulting in symptom improvement and recovery of the hypothalamic-pituitary-adrenal axis. The article highlights the importance of recognizing the potential systemic effects of topical corticosteroids, especially in dental treatments, and recommends vigilance and endocrine evaluation for patients experiencing cushingoid features or adrenal insufficiency symptoms. [Extracted from the article]

Intravaginal rings (IVRs) represent a well-established, woman-controlled and sustained vaginal drug delivery system suitable for a wide range of applications. Here, we sought to investigate the differences in etonogestrel (ENG) and ethinyl estradiol (EE) release from a 3D-printed IVR utilizing continuous liquid interface production (CLIP™) (referred to as CLIPLOW for low drug loading and CLIPHIGH IVRs for high drug loading) and NuvaRing, a commercially available injection molded IVR. We conducted in vitro release studies in simulated vaginal fluid to compare the release of ENG and EE from CLIPLOW IVRs and NuvaRing. CLIPLOW IVRs had a similar hormone dose to NuvaRing and exhibited slightly slower ENG release and greater EE release in vitro compared to NuvaRing. When administered to female sheep, NuvaRing demonstrated greater ENG/EE levels in plasma, vaginal tissue and vaginal fluids compared to CLIPLOW IVR despite similar drug loadings. Leveraging observed hormones levels in sheep from NuvaRing as an effective contraceptive benchmark, we developed a long-acting CLIPHIGH IVR with increased ENG and EE doses that demonstrated systemic and local hormone levels greater than the NuvaRing for 90 days in sheep. No signs of toxicity were noted regarding general health, colposcopy, or histological analysis in sheep after CLIPHIGH IVR administration. Our results provided (1) a comparison of ENG and EE release between a 3D-printed IVR and NuvaRing in vitro and in vivo, (2) a preclinical pharmacokinetic benchmark for vaginally delivered ENG and EE and (3) the generation of a 90-day CLIP IVR that will be utilized in future work to support the development of a long-acting ENG/EE IVR combined with an antiretroviral for the prevention of HIV and unplanned pregnancy. [ABSTRACT FROM AUTHOR]

Bismuth lipophilic nanoparticles (BisBAL NPs) and cetylpyridinium chloride (CPC) are antineoplastic and antimicrobial in vitro. As a next pre-clinical step, a clinically viable dosage form for vaginal application was developed. Compendial pharmacopeial tests (mass uniformity, disintegration, and compressive mechanics) and inductively coupled plasma optical emission spectroscopy were conducted on in-house developed glycerinated gelatin (60:15 v/w) vaginal ovules containing BisBAL NP-CPC. The antimycotic activity of BisBAL NP-CPC vaginal ovules was analyzed using disk diffusion and cell viability XTT assays. The antitumor properties of BisBAL NP-CPC vaginal ovules were assessed by cell viability MTT tests. BisBAL NP-CPC and drug-free vaginal ovules deposited into ex vivo porcine vaginas disaggregated without signs of adverse cytotoxicity within the timespan of clinical efficacy. BisBAL NP-CPC vaginal ovules demonstrated antifungal efficacy comparable to miconazole: C. albicans growth inhibition haloes in diffusion tests were 23 ± 0.968 mm (n = 3) for BisBAL NP-CPC and 20.35 ± 0.899 mm (n = 3) for miconazole. Likewise, BisBAL NP-CPC vaginal ovules reduced HeLa cell growth by 81%, outperforming the clinical reference of 500 μM 5-fluouracil, which induced a 70% growth inhibition. BisBAL NP-CPC incorporated into glycerinated gelatin vaginal ovules constitute an innovative drug delivery system for topical antimycotic and anti-cervical carcinoma treatments. [ABSTRACT FROM AUTHOR]

Depot medroxyprogesterone acetate causes a hypo‐estrogenic state in over half of users although clinical vaginal atrophy causing superficial dyspareunia is thought rarely to occur. This is a case series of ten women using depot medroxyprogesterone acetate who presented with superficial dyspareunia and clinical vaginal atrophy. The women were treated with vaginal estriol cream and their contraception was discontinued or changed. All patients had either a complete resolution of symptoms or a substantial improvement at follow‐up, and the clinical and laboratory findings of vaginal atrophy had resolved. This case series demonstrates that vaginal atrophy may occur more frequently than previously thought. [ABSTRACT FROM AUTHOR]

Introduction: The use of oral azithromycin (AZI) as a preventive measure against postpartum infections of planned vaginal births has garnered a lot of interest in recent years and has been the subject of many randomized controlled trials (RCTs). However, the results from these trials have not been consistent. Therefore, we aim to perform a systematic review and meta‐analysis to determine whether the use of a single‐dose of oral AZI is clinically significant. Methods: We systematically searched PubMed, Embase, and Cochrane Central for RCTs from May to June 2023, comparing a single dose of oral AZI with placebo in patients undergoing planned vaginal delivery at a minimum of 28 weeks of gestational age. The main outcomes were puerperal and neonatal sepsis. Statistical analyses were performed using Review Manager 5.4.1 (Cochrane Collaboration). Heterogeneity was assessed with I2 statistics. Results: Four RCTs were included (mothers, n = 42 235; newborns n = 42 492). Approximately 49.8% of mothers received a single dose of oral AZI for sepsis prophylaxis. Compared with placebo, AZI significantly reduced the incidence of puerperal sepsis (risk ratio [RR], 0.65 [95% confidence interval (CI), 0.55–0.77]; P < 0.001), mastitis or breast abscess (RR, 0.58 [95% CI, 0.42–0.79]; P < 0.001), endometritis (RR, 0.65 [95% CI, 0.54–0.77]; P < 0.001), wound infection (RR, 0.81 [95% CI, 0.69–0.96]; P = 0.013), infection rate (RR, 0.62 [95% CI, 0.51–0.76]; P < 0.001), and fever (RR, 0.50 [95% CI, 0.28–0.89]; P = 0.018) in mothers. No statistically significant differences were identified between groups regarding maternal all‐cause mortality and the use of prescribed postpartum antibiotics. Similarly, no statistical differences were noted in the neonatal group regarding sepsis, infection rate, and all‐cause mortality. Conclusion: AZI appears to be an effective preventive measure against many postpartum infections in mothers but a substantial impact on neonatal outcomes has not yet been conclusively observed. Synopsis: Administration of azithromycin has been shown to prevent postpartum infections and sepsis in mothers undergoing vaginal delivery. [ABSTRACT FROM AUTHOR]

Introduction: When scanning for deep endometriosis a 20 mL syringe is used to insert gel into the vagina for a gel sonovaginography (SVG) examination. This is invasive and can cause discomfort. The aim of this study is to compare participant experience with the self‐administration of 20 mL of gel total using a 10 mL syringe versus 20 mL syringe for participants undergoing a gel SVG ultrasound to assess for any participant discomfort. Methodology: This study was a quantitative pilot study with 31 participants. Consenting participants were instructed to insert a total of 20 mL of gel divided equally into one 20 mL and one 10 mL syringe, into their own vagina prior to SVG. After the SVG, a questionnaire was provided to determine the level of discomfort experienced. Results: Overall participants found the instructions clear and the insertion of either syringe tolerable. The results demonstrated that 22/31 (71%) of participants had no discomfort inserting the 10 mL syringe. In comparison, 17/31 (55%) reported slight or mild discomfort inserting the 20 mL syringe. The majority of participants preferred inserting one 20 mL syringe rather than two 10 mL syringes. Conclusion: Participants found the gel insertion using either syringe tolerable with most participants finding the 10 mL syringe more comfortable but would overall prefer inserting one 20 mL syringe instead of two 10 mL syringes. Future studies on larger numbers of multicultural participants using variable syringe sizes with varying amounts of gel should be considered. [ABSTRACT FROM AUTHOR]

STUDY QUESTION Does oral micronized progesterone result in a non-inferior ongoing pregnancy rate compared to vaginal progesterone gel as luteal phase support (LPS) in fresh embryo transfer cycles? SUMMARY ANSWER The ongoing pregnancy rate in the group administered oral micronized progesterone 400 mg per day was non-inferior to that in the group administered vaginal progesterone gel 90 mg per day. WHAT IS KNOWN ALREADY LPS is an integrated component of fresh IVF, for which an optimal treatment regimen is still lacking. The high cost and administration route of the commonly used vaginal progesterone make it less acceptable than oral micronized progesterone; however, the efficacy of oral micronized progesterone is unclear owing to concerns regarding its low bioavailability after the hepatic first pass. STUDY DESIGN, SIZE, DURATION This non-inferiority randomized trial was conducted in eight academic fertility centers in China from November 2018 to November 2019. The follow-up was completed in April 2021. PARTICIPANTS/MATERIALS, SETTING, METHODS A total of 1310 infertile women who underwent their first or second IVF cycles were enrolled. On the day of hCG administration, the patients were randomly assigned to one of three groups for LPS: oral micronized progesterone 400 mg/day (n = 430), oral micronized progesterone 600 mg/day (n = 440) or vaginal progesterone 90 mg/day (n = 440). LPS was started on the day of oocyte retrieval and continued till 11–12 weeks of gestation. The primary outcome was the rate of ongoing pregnancy. MAIN RESULTS AND THE ROLE OF CHANCE In the intention-to-treat analysis, the rate of ongoing pregnancy in the oral micronized progesterone 400 mg/day group was non-inferior to that of the vaginal progesterone gel group [35.3% versus 38.0%, absolute difference (AD): −2.6%; 95% CI: −9.0% to 3.8%, P- value for non-inferiority test: 0.010]. There was insufficient evidence to support the non-inferiority in the rate of ongoing pregnancy between the oral micronized progesterone 600 mg/day group and the vaginal progesterone gel group (31.6% versus 38.0%, AD: −6.4%; 95% CI: −12.6% to −0.1%, P -value for non-inferiority test: 0.130). In addition, we did not observe a statistically significant difference in the rate of live births between the groups. LIMITATIONS, REASONS FOR CAUTION The primary outcome of our trial was the ongoing pregnancy rate; however, the live birth rate may be of greater clinical interest. Although the results did not show a difference in the rate of live births, they should be confirmed by further trials with larger sample sizes. In addition, in this study, final oocyte maturation was triggered by hCG, and the findings may not be extrapolatable to cycles with gonadotropin-releasing hormone agonist triggers. WIDER IMPLICATIONS OF THE FINDINGS Oral micronized progesterone 400 mg/day may be an alternative to vaginal progesterone gel in patients reluctant to accept the vaginal route of administration. However, whether a higher dose of oral micronized progesterone is associated with a poorer pregnancy rate or a higher rate of preterm delivery warrants further investigation. STUDY FUNDING/COMPETING INTEREST(S) This research was supported by a grant from the National Natural Science Foundation of China (82071718). None of the authors have any conflicts of interest to declare. TRIAL REGISTRATION NUMBER This trial was registered at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/) with the number ChiCTR1800015958. TRIAL REGISTRATION DATE May 2018. DATE OF FIRST PATIENT'S ENROLMENT November 2018. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the safety and acceptability of two fixed-dose 28-day vaginal ring formulations of 17β-estradiol (E2) and progesterone (P4) to treat vasomotor symptoms (VMS) and the genitourinary syndrome of menopause. DARE HRT1-001 was the first-in-woman study of 28-day exposure to two 28-day intravaginal rings (IVRs) designed to release 80 µg/day E2 + 4 mg/day P4 (IVR1) or 160 µg/day E2 + 8 mg/day P4 (IVR2) compared with oral E2 1 mg/day + oral P4 100 mg/day. To assess safety, participants completed a daily diary to record treatment emergent adverse events (TEAEs). To determine acceptability, at the end of treatment IVR users completed a questionnaire assessing tolerability and usability. Enrolled women (n = 34) were randomized to use IVR1 (n = 10), IVR2 (n = 12) or oral (n = 12). Thirty-one participants (IVR1 = 10, IVR2 = 10, oral = 11) completed the study. The TEAE profile of those in the IVR groups were similar to the referent oral regimen. TEAEs related to the study product were more common with IVR2 use. Endometrial biopsies were not performed unless endometrial thickness was >4 mm or for clinically significant postmenopausal bleeding. One IVR1 participant had an endometrial stripe increase from 4 mm at screening to 8 mm at the end of treatment. The biopsy indicated no evidence of plasma cells or endometritis and no evidence of atypia, hyperplasia or malignancy. Two other endometrial biopsies were performed for postmenopausal bleeding with similar findings. There were no clinically meaningful laboratory or vital sign abnormalities or trends identified in observed values or changes from baseline. Pelvic speculum examination identified no clinically significant abnormalities in any participant at any visit. Tolerability and usability data demonstrated that both IVRs were generally highly acceptable. Both IVR1 and IVR2 were safe and well tolerated in healthy postmenopausal women. TEAE profiles were comparable to the referent oral regimen. [ABSTRACT FROM AUTHOR]

Valacyclovir (VACV) was developed as a prodrug of the most common anti-herpetic drug Acyclovir (ACV), aiming to enhance its bioavailability. Nevertheless, prolonged VACV oral treatment may lead to the development of important side effects. Nanotechnology-based formulations for vaginal administration represent a promising approach to increase the concentration of the drug at the site of infection, limiting systemic drug exposure and reducing systemic toxicity. In this study, VACV-loaded nanodroplet (ND) formulations, optimized for vaginal delivery, were designed. Cell-based assays were then carried out to evaluate the antiviral activity of VACV loaded in the ND system. The chitosan-shelled ND exhibited an average diameter of about 400 nm and a VACV encapsulation efficiency of approximately 91% and was characterized by a prolonged and sustained release of VACV. Moreover, a modification of chitosan shell with an anionic cyclodextrin, sulfobutyl ether β-cyclodextrin (SBEβCD), as a physical cross-linker, increased the stability and mucoadhesion capability of the nanosystem. Biological experiments showed that SBEβCD-chitosan NDs enhanced VACV antiviral activity against the herpes simplex viruses type 1 and 2, most likely due to the long-term controlled release of VACV loaded in the ND and an improved delivery of the drug in sub-cellular compartments. [ABSTRACT FROM AUTHOR]

Aim: In modern obstetrics, need of labor induction is increasing along with increased caesarean deliveries. Major contributions for these operative deliveries are due to induction failure. This demands a potent labor‐inducing agent. Dinoprostone gel is an established method but having some drawbacks. Misoprostol could be an effective alternative to Dinoprostone, but its fetal safety is not yet well established. This study aimed to evaluate the fetal safety of vaginal Misoprostol tablet by measuring fetal heart rate changes during induction of labor. Methods: This was a single‐center randomized controlled trial incorporating 140 term women, equally randomized to get either tablet Misoprostol or Dinoprostone gel. Fetal heart rate patterns were compared in both the groups by continuous cardiotocographic tracing. All the data were analyzed on an intention‐to‐treat basis. Results: There were no statistically significant changes in fetal heart rate pattern in both Misoprostol and Dinoprostone groups. Vaginal deliveries were statistically higher in Misoprostol group. Neonatal parameters like 1 min Appearance, Pulse, Grimace, Activity, and Respiration score and neonatal intensive care unit admission were comparable, and there was no significant difference in terms of major adverse events and side effects. Conclusions: Misoprostol is a safe alternative to Dinoprostone gel for induction of labor and found to be more effective labor‐inducing agent. In the background of higher caesarean rate, vaginal Misoprostol can be a potential labor‐inducing agent especially in a resource poor setting. [ABSTRACT FROM AUTHOR]

Long-term chronic inflammation in combination with persistent human papillomavirus infection is one of the potential causes of cervical dysplasia and cancer. Surgical treatment of severe dysplasia, transient insufficiency of the epithelial layer, inflammation that occurs as a result of postoperative trauma can cause long-term consequences for the vaginal biotope. The correct choice of the drug during the rehabilitation period after surgical treatment will prevent the development of complications and recurrences of vaginal flora disorders. The objective: to reduce the frequency of complications after excisional treatment in women with severe cervical intraepithelial neoplasia and to evaluate the clinical effectiveness and safety of using vaginal forms of antimicrobial and antiseptic drugs during postoperative rehabilitation. Materials and methods. 79 women of reproductive age with verified severe cervical intraepithelial neoplasia participated in the study and were divided into three groups. All patients had excisional treatment – radio wave conization of the cervix. In the postoperative period women of the 1st group (n=27) were prescribed a preparation for intravaginal use based on chlorophyllipt thick extract, the 2nd group (n=26) – a preparation that includes chlorophyllipt thick extract and chlorhexidine bigluconate, the 3rd group group (n=26) – suppositorium with chlorhexidine. The postoperative period was divided into 2 visits: on the 30-35th and 60-65th day. Complaints, the degree of subjective feeling of comfort during treatment, the duration and degree of epithelization of the cervix, violation of the biocenosis of the vagina and complications in the form of acute inflammatory diseases of the pelvic organs, strictures of the cervical canal, bleeding in the postoperative period were studied. Results. According to the results of the study, the drug which was prescribed to women of the 2nd group, demonstrated the highest clinical effectiveness both on the 30-35th and on the 60-65th day of the postoperative period, in contrast to the women of the 1st and 3rd groups. The high degree of subjective feeling of comfort after the treatment with the drug, which contains chlorophyllipt extract thick and chlorhexidine bigluconate (women of the 2nd group), on the 30-35th day was 88.46%, which is 14.38% more than in women of the 1st group – 74.08% and by 23.08% more than in patients of the 3rd group – 65.38%. Complete epithelization of the cervix in women of the 2nd group was finished in 76.92%, which is 21.36% more than in the women of the 1st group (55.56%), and 7.69% more than in the patients of the 3rd group (69.23%). Biocenosis of the vagina was evaluated according to the Hay-Ison criteria: in the women of the 2nd group the 1st degree of purity was found in 76.92%, in contrast to the patients of the 1st group – 55, 56%, which is 21.36% more, and 11.54% more than that of women of the 3rd group – 65.38%. After 60–65 days of the postoperative period according to the research data, all women of the 2nd group had complete epithelization of the cervix, normocenosis – in 88.46% of women, in contrast to single-component antiseptic preparations; all patients noted a high degree of subjective feeling of comfort. None of the women from the three studied groups had complications such as acute pelvic inflammatory disease, bleeding and strictures of the cervical canal during the entire observation period. Conclusions. The use of vaginal forms of antiseptics in a combination of chlorhexidine bigluconate and chlorophyllipt extract in women with severe cervical intraepithelial neoplasia demonstrated the highest effectiveness in rehabilitation in the postoperative period compared to single-component antiseptic preparations containing chlorophyllipt or chlorhexidine. [ABSTRACT FROM AUTHOR]

Objective: to develop eligibility criteria for use in non-gynecological cancer patients. Methods: We searched all the articles published in peer-reviewed journals up to March 2021. We utilized the PICOS standards and the following selection criteria: menopausal women with a history of non-gynecological and non-breast cancer who underwent hormone replacement therapy (HRT) using various preparations (oestrogens alone or in combination with a progestogen, tibolone, or tissue selective oestrogen complex) and different routes of administration (including oral, transdermal, vaginal, or intra-nasal). We focused on randomized controlled trials as well as relevant extension studies or follow-up reports, specifically examining recurrence and mortality outcomes. Results: Women colorectal cancer survivors who use MHT have a lower risk of death from any cause than those survivors who do not use MHT. Women who are skin melanoma survivors using MHT have a longer survival rate than non-MHT survivors. There is no evidence that women lung cancer survivors who use MHT have a different survival rate than those who do not use MHT. Conclusions: MHT is safe for women who have a history of colorectal, lung, or skin melanoma cancers. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: Dexamethasone is a potent glucocorticoid that may improve quality of recovery (QoR). We hypothesized that standard administration of dexamethasone at induction may improve QoR compared to placebo in subjects undergoing ambulatory vaginal reconstructive surgeries. Methods: This was a randomized prospective clinical trial on subjects scheduled for ambulatory vaginal reconstructive surgery for prolapse and/or urinary incontinence. Intervention arm subjects were administered dexamethasone and the control group, a placebo (normal saline). Timing of administration, anesthesia medications, postoperative pain medications, and antiemetics were standardized. Primary outcome was difference in QoR (QoR-40) scores 24–48 h after surgery. Power analysis estimated that 27 subjects were required in each group to detect a difference in QoR-40 scores with 80% power and an alpha of 0.05. Results: Fifty-one subjects were enrolled and randomized. 4 withdrew, 1 was excluded, and 46 were analyzed. For the primary outcome, there was no difference in the QoR-40 between the dexamethasone and placebo group (-−13.5 vs −19.6, p=0.24). Postoperative nausea vomiting intensity scores were not different (8.33 vs 9.09, p=1). Pain scores were similar in the two groups (6.0 vs 4.7, p=0.12). Although not statistically significant, surgical satisfaction at 6 weeks was better with dexamethasone (23.5 vs 26.9, p=0.09). Conclusion: Based on this study, a single dose of dexamethasone at the time of induction prior to ambulatory vaginal reconstructive surgery was not associated with improved QoR. Standardized anesthesia protocols may play a role in postoperative nausea, pain control, and thereby QoR in patients undergoing ambulatory vaginal reconstructive surgeries. [ABSTRACT FROM AUTHOR]

Cervical cancer (СС) remains a major global health problem, causing significant morbidity and mortality among women worldwide. Despite significant research efforts and advances in screening and prevention strategies, CС remains an unsolved public health challenge, particularly in low- and middle-income countries. Every year in the world, more than half a million women are diagnosed with СС. The article is devoted to the review of modern scientific publications on the prevention, diagnosis and treatment of cervical lesions on the background of human papilloma virus (HPV) infection. Chronic infection with highly oncogenic strains of HPV in 99.7% is a cause of CC development. A comprehensive understanding of the cofactors of the persistence and realization of the oncogenic potential of HPV is crucial for optimizing strategies for early detection, treatment and prevention of recurrences of dysplastic lesions of the cervical epithelium and cervical cancer. A vaginal gel that contains ingredients of natural origin (hyaluronic acid niosomes, glucan niosomes, Centella asiatica phytosomes, Coriolus versicolor extract, Neem extract, prebiotic, Aloe extract vera, etc.) is scientifically based, available for practical use and clinically effective in patients with HPV infection, it makes a protective and therapeutic barrier in the transformation zone of the cervix. The gel blocks the integration of HPV and in such way it prevents the formation of new lesions, acts as an support medication for re-epithelialization of already existing ones, and stimulates the regeneration of the vaginal microbiota. The effectiveness and safety of vaginal use of this gel which include the natural components in women of reproductive age with HPV-associated lesions of the cervical epithelium has been proven (the results of the multicenter open controlled randomized clinical trial PALOMA, 2021). The expediency and effectiveness of its use in women with HPV-associated lesions of the cervical epithelium of late reproductive and perimenopausal age have been established. Improvement and implementation in practice of the prevention system of cervical pathology and making it closer to European standards is a real step towards overcoming the cervical cancer rate. The mentioned vaginal gel is an innovative and safe medicine which contains only natural ingredients, and its therapeutic effect is aimed at increasing the clearance of HPV, repairing intraepithelial lesions of the cervical epithelium and maintaining the normal bacterial microflora of the vagina [ABSTRACT FROM AUTHOR]

In this multicenter, observational, controlled open-label trial, researchers randomized 200 women with vulvovaginal candidiasis (VVC) to: Group 1, 6-days clotrimazole 2% vaginal cream once-daily plus 15-days concomitant acid pH thymol and zinc-containing cleansing wash (SaugellaActi3) twice-daily; Group 2, 6-days clotrimazole treatment alone. In both groups, pruritus and burning VAS scores improved from baseline at Days 6, 10 and 15. On Day 10 and Day 15, the pruritus score was significantly lower in Group 1 versus Group 2 (P <0.005 at both timepoints), suggesting acid pH thymol and zinc-containing cleansing wash ameliorates VVC-associated pruritus as part of a female hygiene regimen. [ABSTRACT FROM AUTHOR]

The objective: to evaluate the therapeutic effect of a vaginal gel containing hyaluronic acid and decamethoxine for the prevention of obstetric injuries reduction of the birth canal during childbirth, as well as to improve the course of the postpartum period. Materials and methods. An analysis of the course of vaginal births in the fetal head presentation of 500 births that took place in the communal non-commercial enterprise «Kyiv City Maternity Hospital No. 2» during 2021–2022 was carried out. The main group included 250 pregnant women who were given a vaginal gel containing decamethoxine, sodium hyaluronate and lactic acid during childbirth and in the postpartum period. The comparison group consisted of 250 pregnant women who did not use the specified gel during childbirth and in the postpartum period. Results. The average age of patients in the main and the comparison group was 28.92±1.32 and 27.17±1.56 years, respectively. In both groups, primiparous women prevailed – 157 (62.80%) persons in the main group, 158 (63.20%) – in the comparison group, 93 (37.20%) and 92 (36.80%) women had the second labor respectively. There was a tendency to decrease the time of the second period of labor in women of the main group compared to the comparison group. The frequency of episiotomy was 1.63 times lower in the main group than in the comparison group (p<0.05), the rate of soft tissue injuries in childbirth – 1.32 times lower (109 (43.60%) and 144 (57.60%) women respectively; p=0.002). During the week of the postpartum period, the number of patients with discomfort in the vagina and perineum was 2.49 times less in the main group (59 (23.60%) persons) than in the comparison group (147 (58.80%) women; p<0.001), with pain – 1.85 times (88 (35.20%) and 163 (65.20%) individuals respectively; p<0.001). 132 (52.80%) women of the comparison group complained on the limitations in their daily activities due to the mentioned symptoms, which was 2.16 times more than in the main group (61 (24.40%) persons; p<0.001). Conclusions. The use of vaginal gel, which contains hyaluronic acid and decamethoxine, during childbirth and in the postpartum period for prevention of obstetric injuries and improvement the course of the postpartum period is effective, which led to a 1.32- fold decrease of women with vaginal and perineal tears (p<0.05) and 1.63 times – the frequency of episiotomy (р<0.05) and improvement of the course of the postpartum period. [ABSTRACT FROM AUTHOR]

Human papillomavirus (HPV) is one of the most common groups of viruses. Almost all sexually active people can be included in the risk group of HPV infection. Numerous studies indicate a significant prevalence of HPV with a high oncogenic risk, especially among women under 30 years of age. The course of HPV depends on the state of the immune system and can be transient, latent or persistent. A significant role belongs to the state of local immunity and vaginal microbiota. Long-term persistence of HPV in the tissues of the lower part of the genital tract organs provokes the development of precancer and cancer processes. The objective: to evaluate the effectiveness of a vaginal gel based on Coriolus versicolor in the treatment of low-grade cervical lesions caused by HPV. Materials and methods. This study involved 91 HPV-positive women with low-grade pap smear lesions who had regular colposcopy. Women were randomized (in a 1:1:1 ratio) to three treatment groups: A treatment, B treatment, and a control group (expectant approach). Results. Since the state of the immune system largely determines the course of HPV infection, the modern approach to the treatment of HPV-associated diseases involves the use of local intravaginal antiviral and immunomodulatory therapy, which promotes the elimination of pathogens and ensures full epithelization of the cervix, reducing the frequency of recurrence, which preserves women’s reproductive health. The percentage of patients with a normal Pap smear and serial colposcopy in 6 months was significantly higher in the treatment group than in the control group (84.9% vs. 64.5%, respectively; p=0.031; this difference was even more prominent in the high-risk subgroup of HPV-infected women (87.8% vs. 56.0% for the treatment and control groups, respectively; p=0.003). Significant differences were also observed at 3 months in the overall sample of patients (78.0% vs. 54.8% for the treatment and control groups, respectively; p=0.023) and the subgroup of high-risk HPV-infected women (79.5% vs. 52 .0%, respectively; p=0.017). Conclusions. Treatment with a Coriolus versicolor vaginal gel has demonstrated greater clinical benefit than a standard expectant approach in clinical practice for patients with total and high risk of HPV infection for the treatment efficacy of HPVrelated cervical lesions and removal of all HPV strains from the organism after one six-month period. [ABSTRACT FROM AUTHOR]

The objective of this research is to formulate lyophilized fluconazole-loaded nanocellulose-gellan scaffolds cross-linked using trisodium trimetaphosphate as a vaginal drug delivery system. The effect of polymers (nanocellulose and gellan gum) and cross-linking agents on drug release and mucoadhesive strength were determined by approaching a two-factor three-level central composite experimental design. The optimal formulation of the fluconazole-loaded cross-linked rice or wheat nanocellulose-gellan based scaffolds comprised of the concentration of polymers (4.91 % w/v or 4.99 % w/v) and trisodium trimetaphosphate (16.43 % w/v or 15.83 % w/v), respectively. The infrared spectra confirmed the cross-linking of nanocellulose and gellan gum while the thermal graph revealed the higher thermal stability of cross-linked scaffolds. The diffractogram of the scaffolds unveiled their amorphous nature while the electron micrographs depict the porous nature of the fluconazole-loaded nanocellulose-gellan scaffolds. The phosphorylated cross-linked nanocellulose-gellan scaffolds represent more swelling (8-fold higher), porosity (>83 %), tensile strength (>34 MPa), and mucoadhesive strength (>1940 mN), and less enzymatic degradation rate over the non cross-linked scaffolds. The optimal batch of cross-linked nanocellulose-gellan scaffolds provided a sustained release of 99 % of fluconazole over 24 h with 1.19-fold higher ex-vivo vaginal permeation over the native scaffolds. In addition, the phosphorylated nanocellulose-gellan based scaffolds exhibit improved antifungal activity and non-cytotoxicity. [ABSTRACT FROM AUTHOR]

The investigation studied the enkephalinergic neuro fibers (En) contained in the Lower Uterine Segment (LUS) during the prolonged dystocic labor (PDL) with Labor Neuraxial Analgesia (LNA). PDL is generally caused by fetal head malpositions in the Occiput Posterior Position (OPP), Persistent Occiput Posterior Position (POPP), in a transverse position (OTP), and asynclitism (A), and it is detected by Intrapartum Ultrasonography (IU). The En were detected in the LUS samples picked up during cesarean section (CS) of 38 patients undergoing urgent CS in PDL, compared to 37 patients submitted to elective CS. Results were statistically evaluated to understand the differences in En morphological analysis by scanning electron microscopy (SEM) and by fluorescence microscopy (FM). The LUS samples analysis showed an important reduction in En in LUS of CS for the PDL group, in comparison with the elective CS group. The LUS overdistension, by fetal head malpositions (OPP, OTP, A) and malrotations, lead to dystocia, modification of vascularization, and En reduction. The En reduction in PDL suggests that drugs used during the LNA, usually local anesthetics and opioids, cannot control the "dystocic pain", that differs from normal labor pain. The IU administration in labor and the consequent diagnosis of dystocia suggest stopping the numerous and ineffective top-up drug administration during LNA, and to shift the labor to operative vaginal delivery or CS. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the efficacy and safety of vaginal energy-based therapies in treating female SUI. Methods: The PubMed, EMBASE, Web of Science, and Scopus databases were searched up to September 2022 to identify RCTs comparing energy-based therapies with placebo intervention in treating female SUI. The primary outcome was International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score. Secondary outcomes included the 1-h pad test and cure rate. Results: A total of 577 patients from 6 studies were included in the meta-analysis. Energy-based therapies did not significantly improve the ICIQ-SF score at all visits (≤ 1 month: SMD, -0.39; 95% CI − 0.80 to 0.03; P = 0.07; 3 months: SMD, − 1.32; 95% CI − 4.07 to 1.43; P = 0.35; 6 months: SMD, − 0.39; 95% CI − 0.91 to 0.12; P = 0.14). The subgroup analysis showed that there was no significant improvement in ICIQ-SF score in the CO2 laser group compared to the placebo group at all visits (≤ 1 month: SMD, − 0.13; 95% CI − 0.59 to 0.34; P = 0.59; 3 months: SMD, − 1.50; 95% CI − 3.91 to 0.92; P = 0.22; 6 months: SMD, 0.13; 95% CI − 0.47 to 0.72; P = 0.67). Meta-analysis was not performed in Er: YAG laser and radiofrequency therapy due to insufficient trials. Conclusion: Based on the limited clinical evidence, our meta-analysis showed no prior efficacy of energy-based therapy over placebo intervention. However, the results of this meta-analysis should be taken with caution due to the limited amount of available evidence and the heterogeneity among the included studies. PROSPERO registration number: CRD42022360471. [ABSTRACT FROM AUTHOR]

Background: Prior to a first-trimester abortion, a vaginal misoprostol administration has been shown to have less adverse effects than either an oral or sublingual dose. Objective: The aim of the current work was to determine whether a combined therapy with isosorbide mononitrate and misoprostol for preoperative cervical ripening in the first trimester would result in improved clinical effectiveness and fewer side effects compared with misoprostol used alone. Patients and Methods: This randomized clinical trial study included a total of 54 women with first trimester missed abortion between 7-12 weeks, attending at Gynecologic Oncology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine, Zagazig University Hospitals. They were divided into two equal groups: Group I: included 27 cases received 400 µg misoprostol inserted in the posterior fornix 4 hours prior to the surgical evacuation. Group II: included 27 cases received 20 mg isosorbide mononitrate and 200 µg misoprostol inserted in the posterior fornix 4 hours prior to the surgical evacuation. Results: Both groups were effective in achieving cervical ripening in terms of effacement, dilatation and softening but combination group was more effective than misoprostol group. The operative duration was statistically significantly shorter in combination group than in misoprostol group. Colicky lower abdominal pain was statistically significant and more prominent in group I (Misoprostol group) while headache was more significant in group II. Conclusion: It could be concluded that combination of both misoprostol and NO donors makes a synergism in action with fewer side effects. It softens the cervix and decreases its length with less operative time. It has less abdominal pain than misoprostol alone. [ABSTRACT FROM AUTHOR]

Purpose: To compare the first-time success rate and prognosis of repairing vesicovaginal fistula (VVF) by transvaginal and transvesical approaches, and to highlight a modified transvaginal repair technique which only require single layer closure of an annular vaginal flap. Methods: Retrospective analysis of 57 consecutive patients who underwent VVF repair between 2007 and 2021. Fistula characteristics, operative factors, post-surgical complications and outcomes were analyzed. Results: A total of 57 women with a median age of 50.4 (27–75) years were included. The history ranged from 7 days to 8 years, with an average of 20 months. 56 cases (98.2%) of VVFs were caused by pelvic surgery, and only one resulted from difficult labour. 11 cases (19.3%) had a history of surgical repair failure. All 57 cases of surgery were smoothly completed. Among them, 17 patients underwent transvaginal repair, whereas 40 (70.2%) women had transvesical repair. Transvaginal approach had a significantly shorter operative time, less intraoperative blood loss, reduced postoperative hospital stay, less hospitalization cost and lower minor complication rates than transvesical group (p < 0.05). No serious complications occurred in the two groups. No cystostomy was performed in the transvaginal group, but 12 cases (30%) in the transvesical group. The average follow-up time was 18.5 (3–48) months. The first-time success rates of transvaginal and transvesical techniques were 82.3 and 75%, respectively. Conclusion: VVF repair with single layer closure of an annular vaginal flap is a technically feasible, simple and successful approach with significantly better operative parameters and lower complications rates. [ABSTRACT FROM AUTHOR]

Muco-adhesive drug delivery systems continue to be one of the most studied for controlled pharmacokinetics and pharmacodynamics. Briefly, muco-adhesive polymers, can be described as bio-polymers that adhere to the mucosal (mucus) surface layer, for an extended residency period of time at the site of application, by the help of interfacial forces resulting in improved drug delivery. When compared to traditional drug delivery systems, muco-adhesive carriers have the potential to enhance therapeutic performance and efficacy, locally and systematically, in oral, rectal, vaginal, amongst other routes. Yet, the achieving successful muco-adhesion in a novel polymeric drug delivery solution is a complex process involving key physico-chemico-mechanical parameters such as adsorption, wettability, polymer chain length, inter-penetration and cross-linking, to list a few. Hence, and in light of accruing progress, evidence and interest, during the last decade, this review aims to provide the reader with an overview of the theories, principles, properties, and underlying mechanisms of muco-adhesive polymers for pharmaceutics; from basics to design to characterization to optimization to evaluation to market. A special focus is devoted to recent advances incorporating bio-inspired polymers for designing controlled muco-adhesive drug delivery systems. [ABSTRACT FROM AUTHOR]

Background. Genital ulcers are an unusual complaint in pediatrics. Most are caused by sexually transmitted infections (stIs), although there are non-venereal etiologies that should also be considered. lipschütz ulcers are a rare and frequently underdiag- nosed cause of non-infectious genital ulcers, which are usually preceded by a viral trigger and have a self-limiting course. Case report. a 17-year-old female patient presented with an acute vulvar lesion, accompanied by complaints of malaise, fever and odynophagia. she was sexually active. on examination, she had bilateral tonsillar exudates, hepatomegaly and a painful, well-limited vulvar ulcer. Complementary exams ruled out most common stIs, and the Paul-Bunnel test was positive. treatment was supportive. Based on the clinical presentation and laboratory results, the diagnosis of a lipschütz ulcer, in the context of acute mononucleosis, was made. three weeks after the initial presentation, the lesion was fully healed. the case was entirely managed in ambulatory care. Conclusions. this case represents a rare but important differential diagnosis of genital ulceration. the prompt suspicion of a lipschütz ulcer spared the patient from unnecessary exams and therapies. It should be noted that this disease mainly affects young adolescents, for whom the disclosure of its symptoms might be challenging. a trusting doctor–patient relationship is fundamental to ensure proper management and follow-up. [ABSTRACT FROM AUTHOR]

Background and purpose: Candida infections have increased significantly in the antimicrobial resistance era, and synthetic antifungal drugs have limitations. The present work aimed to review the antifungal properties of Zataria multiflora (Z. multiflora) as an herbal remedy. Method: PubMed, Scopus, ScienceDirect, Web of Science, SID, Civilica, and Magiran databases were searched for the antifungal activity on in vitro, in vivo, dental biofilm, and clinical studies of Z. multiflora on Candida species. Results: Overall, 33 articles evaluated the effect of Z. multiflora on Candida species and classified them into four groups, as follows in vitro (23), dental biofilm (6), in vivo (2), and clinical studies (3). All studies considered Z. multiflora effective in reducing or even inhibiting the growth of Candida species. NoMFC significant differences were seen in the effect of Z. multiflora on susceptible Candida compared to the resistant groups of Candida in the studies. It was also influential in inhibiting C. parapsilosis, C. glabrata, C. krusei, C. kefyer, and C. zeylanoides. Conclusion: Considering the side effects and resistance of current antifungal drugs as well as the benefits of using herbal medicines, such as lower cost, less likely to develop drug resistance, the absence of side effects, and toxicity compared with chemical ones, it is possible as a powerful alternative to replace or combine with the current antifungal for Candida infection therapy along with other therapies. [ABSTRACT FROM AUTHOR]

Background: In vitro, Ziziphus Spina-Christi (ZSC) leaves have been shown to have antimicrobial and antifungal effects. This study aimed to examine the effects of Ziziphus Spina leaves hydro-alcoholic extracts with Clotrimazole against Candida albicans in female rats. Methods: Four groups of rats were infected vaginally with C. Albicans, and 1 group not infected was considered negative control. The infected groups received the following treatments: 2 groups were treated with vaginal 5%, or 10%, of Ziziphus Spina extract creams. One group received 1% clotrimazole, and 1 group did not receive any treatment considered a positive control. Results: The mean number of colony-forming units (CFUs) before the intervention was 195.83 ± 395.126 in the 5% ZSC group, 346.33 ± 396.719 in the 10% ZSC group, 345.17 ± 507.431 in the clotrimazole group, 212.20 ± 148.304 in the positive control group (P =.604), and 0 in the negative control group (P =.003). After 1 week, the average number of CFUs considerably dropped to 65.14 ± 36.03 in the 5% ZSC group, 1.43 ± 3.60 in the 10% ZSC group, and 0.43 ± 1.13 in the clotrimazole group. The number in the positive control group remained unchanged (212.20 ± 148.304) (P =.005). After 2 weeks, the average number of CFUs was 0 in the 10% ZSC group, Clotrimazole and negative control groups and was 4.57 ± 23.99 in the 5% ZSC group (P <.001). Conclusions: Our findings indicated that the effectiveness of Vaginal creams containing 10% Ziziphus Spina is similar to Clotrimazole in eliminating C. Albicans. [ABSTRACT FROM AUTHOR]

Over the past 50 years, pessary use has increased in popularity and has become an essential pelvic organ prolapse (POP) management tool. However, evidence is lacking to define care standardization, including pessary fitting, routine maintenance, and management of pessary-related complications. This clinical consensus statement (CCS) on vaginal pessary use and management for POP reflects statements drafted by content experts from the American Urogynecologic Society and Society of Urologic Nurses and Associates. The purpose of this CCS is to identify areas of expert consensus and non-consensus regarding pessary fitting, follow-up, and management of pessary complications to improve the safety and quality of care where evidence is currently limited. The American Urogynecologic Society and Society of Urologic Nurses and Associates' vaginal pessary for POP writing group used a modified Delphi process to assess statements that were evaluated for consensus after a structured literature search. A total of 31 statements were assessed and divided into 3 categories: (1) fitting and follow-up, (2) complications, and 3) quality of life. Of the 31 statements that were assessed, all statements reached consensus after 2 rounds of the Delphi survey. This CCS document hopefully serves as a first step toward standardization of pessary care, but the writing group acknowledges that improved research will grow the base of knowledge and evidence providing clinicians a foundation to manage pessary care effectively and confidently. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: There has been renewed interest in the management of postoperative pain after benign gynecological surgery. The purpose of the study was to determine if the use of intraoperative and immediate postoperative pain medication differs between vaginal and laparoscopic surgery in women with pelvic organ prolapse. Methods: The study included women who had undergone pelvic organ prolapse repair between 2014 and 2019 in two tertiary care hospitals. We collected demographic data and pain medication used during and after surgery, including opioids, local anesthetics, gabapentin, ketorolac, ibuprofen, and acetaminophen. Data analyses were performed using STATA Version 16.1. A p value <0.05 was considered to indicate statistical significance. Results: A total of 195 women were included in the study, with 98 in the vaginal and 97 in the laparoscopic group. Intraoperative opioid use in the two groups was similar (25 morphine milligram equivalent [MME], p = 0.34). However, women in the laparoscopic group received significantly more intravenous and local anesthesia (lidocaine: 60 vs 40 mg; bupivacaine 49.6 vs 20 ml, p < 0.001). Postoperatively, although women in the vaginal group required almost twice as many narcotics as those in the laparoscopy group (MME = 28 vs 15, p < 0.001), after controlling for confounders in the multivariate analysis, there were no differences in postoperative pain requirements between the two groups. Recovery time had a significant impact on opioid and acetaminophen use (p < 0.05). Conclusion: Use of pain medication was similar in the intraoperative and immediate postoperative period after pelvic organ prolapse surgery when comparing the vaginal and laparoscopic approaches after controlling for potential confounding factors. [ABSTRACT FROM AUTHOR]

Dysbiotic changes in microbial ecosystem of the female lower genital tract are risk factors for spontaneous abortions, spontaneous preterm births, intra-amniotic infection, postpartum endometritis, and adverse perinatal outcomes. However, the opinions about the expediency of antimicrobial therapy in women with bacterial vaginosis and a history of preterm birth are controversial, and discussions and the search for an effective method of treatment are still continuing. Treatment of dysbiosis of the vaginal microbiota requires a complex approach for not only the pathogen elimination, but also for the restoring of the normal vaginal biotope. The objective: to evaluate the effectiveness of correction of dysbiotic disorders of the vaginal microbiota in women with risk factors for premature birth using the prebiotic topical therapy. Materials and methods. The studied cohort included 105 women with risk factors for premature birth. I group included 38 women at the stage of pregnancy planning, II group - 39 pregnant women, III group - 28 pregnant women from the moment of their first visit to the female consultation for pregnancy monitor. The control group included 20 conditionally healthy pregnant women at the same gestational age. The patients of the I and II groups after diagnosis of bacterial vaginosis (BV), vulvovaginal candidiasis, or aerobic vaginitis received etiotropic topical therapy in accordance with the recommendations of the Centers for Disease Control and Prevention and International Union against sexually transmitted infections. Bacterial vaginosis was treated by clindamycin cream (2 %) once a day for 7 days; aerobic vaginitis - vaginal tablets which contain 10 mg of dequalinium chloride for 6 days; candida vaginitis - fenticonazole 600 mg in one vaginal capsule once followed by topical application of a prebiotic complex (oligosaccharide, sodium hyaluronate, xylitol, vitamins, lactose) for 10 days. Then pH balance and normocenosis of the vagina were supported by the use of one vaginal capsule of the prebiotic complex per week till the 22nd week of gestation. The pregnant women in the III group with similar pathologies received only classical antimicrobial therapy with antibiotics and/or antifungal drugs. The assessment of the vaginal microbiota was carried out at the time of the patients inclusion in the study and at the 17-19 weeks of gestation by determination of the vaginal pH and using molecular biological and bacterioscopic methods. Results. The effectiveness of BV and mixed vaginitis therapy in all groups was high, the frequency of BV detection after treatment decreased from 28.9 % to 2.6 % in the I group and from 32.1 % to 3.6 % - in the III group. In the I and II groups, in which the patients received complex treatment with the prebiotic complex, the quantity of women with normocenosis of the vagina increased significantly (from 39.5 % to 89.5 % in the I group; from 35.9 % to 89.7 % in the II group), the frequency of the intermediate state of the vaginal microbiota decreased twice (from 13.2 % to 7.9 % in the I group and from 15.4 % to 7.7 % in the II group). In patients of the III group, the incidence of normocenosis increased slightly (from 32.1 % to 39.3 %), but the rate of pregnant women with an intermediate state of vaginal microbiota increased significantly (from 14.3 % to 46.4 %), which is a threat to the recurrence of dysbiotic processes. Conclusions. The topical use of the prebiotic complex, which contains oligosaccharide, sodium hyaluronate, xylitol, vitamins and lactose, is effective in the management of symptoms and pathogenic load in uncomplicated vaginal infection, which is manifested by a decrease in the prevalence of intermediate states of the microbiota and a steady increase in normocenosis. The complex therapy with antibiotics/antifungal agents with a vaginal prebiotic complex provides an effective restoration of the vaginal flora to the state of normocenosis compared to treatment with antibiotics/antifungal agents only. [ABSTRACT FROM AUTHOR]

Postpartum depression (PPD) is detrimental to the mother and the family as a whole. Early initiation of appropriate treatment is important. The aim of this pilot study was to evaluate the efficacy and adverse effects of oestradiol treatment. We performed a pilot double-blind, randomized, placebo-controlled study. Major depression was diagnosed using the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I), and the severity of depression was evaluated using the Edinburgh Postnatal Depression Scale (EPDS). The duration of treatment with sublingual oestradiol hemihydrate (1–3 mg/day) was 12 weeks. The treatment group consisted of 16 mothers and the placebo group of 14 mothers. Thirteen mothers in the treatment group and ten in the placebo group recovered from depression during the treatment period as measured with the EPDS (<10). There was no evidence to suggest that oestradiol was more effective than placebo. More mothers in the treatment group than in the placebo group (eight vs. one) received gestagen treatment for irregular bleeding. Oestradiol did not disturb breastfeeding. The mean number of other adverse effects per mother was lower in the treatment group, and these were mostly somatic symptoms. Our findings warrant further studies on oestrogen therapy for PPD with and without antidepressant and gestagen therapy, and on adverse effects (including effects on vaginal bleeding and breastfeeding). [ABSTRACT FROM AUTHOR]

Objective: To assess efficacy and safety of a single-dose vaginal clindamycin gel for bacterial vaginosis treatment.Methods: We conducted a double-blind, placebo-controlled, randomized study comparing clindamycin gel with placebo (2:1 ratio). Entry required clinical diagnosis of bacterial vaginosis, that is, all four Amsel's criteria, without other genital infections. Nugent scores of 7-10 were required for efficacy assessment, per updated 2019 U.S. Food and Drug Administration guidance. Patients were evaluated at screening, day 7-14, and day 21-30 (test of cure). Clinical cure was defined as resolution of three of four Amsel's criteria. Bacteriologic cure was defined as Nugent score lower than 4. Therapeutic cure was both clinical and bacteriologic cure. Primary outcome was clinical cure at the test-of-cure visit. Secondary endpoints were clinical cure at day 7-14, and bacteriologic and therapeutic cures at day 7-14 and test of cure. A sample size of 188 patients in the clindamycin group compared with 94 patients in the placebo group had 90% power to detect statistically significant difference (P=.05, 2-tailed).Results: Participants were seen between July 9, 2020, and November 12, 2020. Of 307 randomized women, 56.0% were Black and 88.3% reported one or more previous bacterial vaginosis episodes. In the modified intention-to-treat population, 70.5% of patients in the clindamycin group and 35.6% in the placebo group achieved clinical cure at test of cure (primary outcome) (difference of 34.9, 95% CI 19.0-50.8), as did 77.5% of patients in the clindamycin group and 42.6% of patients in the placebo group in the per-protocol population (difference of 34.9, 95% CI 17.0-52.7). Statistically significant differences between groups were seen for all secondary endpoints. Clinical cure rate in patients in the clindamycin group with more than three bacterial vaginosis episodes in the prior year was 70.0%. Approximately 15% (15.3%) of patients in the clindamycin group experienced one or more treatment-emergent adverse events related to study treatment, as did 9.7% of patients in the placebo group. The most frequent treatment-related, treatment-emergent adverse event was vulvovaginal candidiasis.Conclusion: A new, single-dose clindamycin vaginal gel was highly effective, with excellent safety, in women disproportionately affected by bacterial vaginosis, with Nugent scores of 7-10 at study entry.Funding Source: The study was funded by Daré Bioscience, Inc.Clinical Trials Registration: ClinicalTrials.gov, NCT04370548. [ABSTRACT FROM AUTHOR]

Background: Vulvovaginal atrophy (VVA) usually occurs during and after menopause due to low estrogen levels and can cause frustrating symptoms. Existing treatments such as estrogen compounds have undesired side effects. Objectives: This study was conducted to assess the effectiveness of a chicken tallow product for vaginal use on subjective symptoms of VVA in women with breast cancer. Methods: Menopause induced by chemical drugs with subjective symptoms of VVA were selected from the Oncology-Radiotherapy Clinic of Shohadaye Tajrish Hospital between March and July 2020. Informed consent was obtained. Patients were instructed to apply 5g cream every other night before bedtime for 2weeks, and 2 nights a week for the next 2 weeks and stop the medication. Patients were assessed at the time of initiation of medication, and 2, 4, 6, and 8 weeks after initiation of the trial, and VVA subjective symptoms were assessed. VVA subjective symptom score (VVA-SSS) form was used to assess itching, burning, dryness, and dyspareunia, using a 5-point Likert scale. Data were, then, analyzed. Results: Fifty women were included in the study (age above 18 years). All 5 monitored indices (itching, burning, dryness, dyspareunia, and VVA subjective symptoms score) diminished after initiation of intervention and reached a minimum level after 4 weeks of intervention (1.10 ± 1.16 baseline to 0.04 ± 0.20 at 4 weeks for itching, 1.42 ± 1.09 to 0.04 ± 0.20 for burning, 2.68 ± 0.91 to 0.30 ± 0.54 for dryness, 2.96 ± 0.88 to 0.50 ± 0.61 for dyspareunia, and 8.12 ± 2.70 to 0.86 ± 1.07 for VVA-SSS). During the 4 weeks following discontinuation of treatment, the symptoms slightly increased but remained significantly lower than the baseline (P-value < 0.001 for all 5 indices at all monitored time points). Conclusions: The proposed treatment, rooted in Persian traditional medicine, may offer a safe and effective treatment for VVA symptoms in BCS. [ABSTRACT FROM AUTHOR]

Aim: To compare the success rate of vaginal misoprostol versus intravenous (IV) oxytocin in termination of pregnancy in the second trimester intrauterine fetal death (IUFD). Methods: This was an open‐label randomized controlled study for 106 women with second trimester IUFD. Patients were randomly divided into two groups: women given vaginal misoprostol (400 mcg every 6 h up to 48 h) versus those given IV oxytocin (starting with 50 units up to a maximum of 300 units). When the first‐line treatment (as mentioned above) failed, treatment methods were replaced with each other. When the second‐line treatment failed, the patients underwent dilation and evacuation. Results: The first‐line treatment yielded the successful rate of 88.7% versus 73.7% for misoprostol versus oxytocin, respectively (p = 0.047). Among those with first‐line treatment failure, the second‐line treatment yielded success rate of 85.7% versus 83.3% for misoprostol versus oxytocin (p = 0.891). The mean duration of induction to delivery in women with successful response to first‐line treatment was 28.72 and 20.55 h after initially receiving misoprostol versus oxytocin, respectively (p < 0.001). While during second‐line treatment, this mean interval was not significantly different among those with misoprostol versus oxytocin (p = 0.128). No severe adverse events were observed. Conclusion: Vaginal misoprostol was associated with higher termination rate than oxytocin without adverse events when used as the first‐line treatment. Both methods yielded the same success rate when used as the second‐line treatment. [ABSTRACT FROM AUTHOR]

Molar incisor hypomineralization (MIH) affects the first permanent molars and permanent incisors whose formative embryological process develops around birth and the first year of life. This study's main objective is to assess the relationship between MIH, on the one hand, with the administration during childbirth of epidural bupivacaine, intramuscular meperidine with haloperidol, synthetic intravenous oxytocin, and prostaglandins such as dinoprostone vaginally, and on the other hand, with suffered pathologies during the first year of life. Cross-sectional retrospective study was carried out on 111 children who attended dental check-ups. Oral examination was carried out to determine MIH involvement. Data on the administration of medications during delivery and the illnesses suffered by the children in the first year of life were taken from the hospital records. Significant relationship with Pearson's chi-square was found between the presence of MIH and the administration of meperidine with haloperidol intramuscularly and the vaginal administration of dinoprostone during labour. Also in children who have suffered serious infections and those who have received antibiotics in early childhood. In recent years there has been a growing trend in many countries to medicalize childbirth even above what the World Health Organization recommends. Some of the drugs used in these protocols could be involved in the appearance of dental mineralization alterations of the MIH type and this would help to explain the increase in its prevalence. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to compare intracervical (IC) and intravaginal (IV) application of prostaglandin E2 (PGE2) for labor induction in term pregnancies with unfavorable cervix.Study Design: This prospective randomized trial included 212 pregnant women with term pregnancy and unfavorable cervix randomly assigned for labor induction with either IC (0.5 mg) or IV (2 mg) PGE2 formulation. Main outcome measured was time interval from labor induction to delivery. Difference in mode of delivery and adverse perinatal outcomes between two studied groups was also investigated. Significance was set at p < 0.05.Results: Studied groups did not significantly differ regarding main characteristics such as age, parity, body mass index or Bishop score. Women in IV group compared to those in IC group had shorter induction to delivery time interval (p < 0.001) and induction to active phase time interval (p = 0.001), higher prevalence of vaginal delivery within 24 h of labor induction (63,3% vs 40,6%, p = 0.002) and higher prevalence of successful induction of labor (95,9% vs. 86,5%, p = 0.020). The analysis did not reveal significant difference in mode of delivery between groups (p = 0.453) or other adverse perinatal outcomes.Conclusion: IV application of PGE2 compared to IC application is more efficacious and comparably safe for labor induction in term pregnancies with unfavorable cervix and should be the method of choice for labor induction. [ABSTRACT FROM AUTHOR]

The article focuses on the study to compare between the effectiveness and safety of two different daily doses of vaginal progesterone (400 vs. 200 mg) in the prevention of preterm labor in twin pregnancy. It mentions that this is a prospective single-blinded randomized controlled trial conducted on 100 primi-gravida who had twin pregnancy and attended the antenatal clinic of a University hospital.

Miscarriage, defined as the loss of a pregnancy before 24 weeks of gestation, is the most common complication of early pregnancy, affecting approximately 15% of clinically recognized pregnancies. The steroid hormone progesterone is essential for the maintenance of pregnancy, and progesterone deficiency is associated with miscarriage. Two important clinical risk factors for miscarriage are a history of previous miscarriages and vaginal bleeding in early pregnancy. Progesterone supplementation has therefore been attempted to prevent miscarriages in asymptomatic women with a history of miscarriages and in women who have started to bleed in early pregnancy. The latest evidence from high quality clinical trial research has shown that vaginal micronized progesterone treatment of women with the dual risk factors of early pregnancy bleeding and a history of one or more previous miscarriages increases the likelihood of a successful live birth (relative rate 1.08, 95% CI 1.02 to 1.15, high-certainty evidence). This treatment has also been shown to be cost-effective, leading to the National Institute for Health and Care Excellence committee for the guideline 'Ectopic pregnancy and miscarriage: diagnosis and initial management (NG126)' updating their guidance to recommend the use of vaginal micronized progesterone to treat women with the dual risk factors of a history of one or more previous miscarriages and early pregnancy bleeding. This change in practice has the potential to prevent up to 8,450 miscarriages a year in the UK. [ABSTRACT FROM AUTHOR]

Menopause signifies permanent cessation of ovarian function and the end of a woman's reproductive potential. Menopausal transition plays a major role in many symptoms common in middle age and may contribute to chronic conditions and disorders of aging. An evidence-based plan of care improves outcomes, enhancing quality of life. [ABSTRACT FROM AUTHOR]

Background: Considering the importance of sexual function, high prevalence of sexual dysfunction (especially dyspareunia caused by atrophic vaginitis) in breastfeeding women, and lack of effective interventions, the present research aimed to determine the effect of oxytocin (OXT) vaginal gel on sexual function (primary outcome), sexual satisfaction, and depression (secondary outcomes) in the breastfeeding women.Methods: This randomized triple-blind controlled trial was conducted on 64 breastfeeding women who referred to health centers in the city of Tabriz, Iran, in 2020-21. Participants were equally assigned to intervention/control groups using block randomization. 200 IU of OXT vaginal gel was given to the participants in the intervention group daily for eight week and the same protocol was carried out for the control group with placebo. Standard questionnaires of Female Sexual Function Index (FSFI), Edinburgh Postpartum Depression Scale (EPDS) and Sexual satisfaction scale for women (SSSW) were completed at baseline and 8 weeks after intervention. ANCOVA test was used to compare post-intervention mean score of the groups, adjusted for the baseline values.Results: After intervention, there was no statistically significant difference between groups in terms of mean total score of FSFI (Adjusted Mean Difference (AMD): 1.14; 95% Confidence Interval (95% CI): -1.28 to 9.16; P= 0.349) and sexual satisfaction (AMD: 5.01; 95% CI: -0.53 to 10.56; P= 0.075). However, there was statistically significant difference between the groups in terms of mean scores of sexual contentment (AMD: 1.56; 95% CI: 0.29 to 2.83; P = 0.017) and depression (AMD: -1.90; 95% CI: -1.27 to -2.54; P < 0.001). One participant in the OXT group and one participant in the placebo group reported mild uterine contraction and one person in the placebo group reported vaginal burning sensations.Conclusions: No evidence was found for the effects of OXT gel in the improvement of FSFI, even though, OXT significantly improved sexual satisfaction in the domain of contentment, and improved the symptoms of depression in comparison to the placebo group. However, a definite conclusion requires more research in this regard.Trial Registration: the Iranian Registry of Clinical Trials (IRCT), code: IRCT20120718010324N55 , Date of registration: 27/05/2020, URL: https://en.irct.ir/user/trial/44986/view . [ABSTRACT FROM AUTHOR]

Silver nanoparticles (AgNPs) are widely applied in the field of personal protection for their powerful toxic effects on cells, and recently, a new type of vaginal gel with AgNPs is used to protect the female reproductive tract from microbes and viruses. However, a high risk of AgNPs to the fetus and the underlying mechanism of AgNPs to interfere in embryo development still remain unclear. Thus, this study investigated the impact of two drugs of vaginal gel with AgNPs on reproductive capability of the female mouse by animal experiment. Then, kinetics of AgNPs affecting embryo development was investigated by in vitro embryos culturing, and cell membrane potential (CMP) of zygotes was analyzed by DiBAC4(3) staining. Results indicated that one of the drugs of vaginal gel certainly injured embryo development in spite of no apparent histological change found in ovaries and uteruses of drug-treated mice. In vitro embryo culturing discovered that the toxic effect of AgNPs on embryo development presented particle sizes and dose dependent, and AgNP treatment could rapidly trigger depolarization of the cell membrane of zygotes. Moreover, AgNPs changed the gene expression pattern of Oct-4 and Cdx2 in blastocysts. All these findings suggest that AgNPs can interfere with normal cellular status including cell membrane potential, which has not been noticed in previous studies on the impact of AgNPs on mammalian embryos. Thus, findings of this study alarm us the risk of applying vaginal gel with AgNPs in individual caring and protection of the female reproductive system. [ABSTRACT FROM AUTHOR]

Background: Different progesterone doses and routes are used for luteal phase support in stimulated intrauterine insemination (IUI) cycles, but the optimal supplementation scheme has not yet been determined. Therefore, our aim was to compare the administration of two different doses of vaginal progesterone with two doses of intramuscular (IM) progesterone for luteal phase support in patients undergoing IUI cycles. Methods: In this randomized clinical trial, 312 women with unexplained or malefactor infertility intending to start IUI cycles between April 2015 and January 2018 were included. They were randomized into four groups (n=78/each) including group 1 who received IM progesterone in oil (25 mg daily), group 2 who received IM progesterone in oil (50 mg daily), group 3 who received progesterone suppository (400 mg daily), and group 4 who received progesterone suppository (800 mg daily; 400 mg twice daily). The primary outcome was the clinical pregnancy rate. The ongoing pregnancy rate, abortion rate, and patients’ satisfaction, and convenience the secondary outcomes. Results: In our study, the overall clinical and ongoing pregnancy rates per cycle with COS and IUI were 16.02% and 12.8%, respectively. There were no significant differences in clinical pregnancy, ongoing pregnancy, and abortion rates among groups (p=0.84). The overall patients’ satisfaction and convenience was significantly higher in the vaginal progesterone suppository groups than the IM progesterone groups (p=0.001). Conclusion: The results of this study showed that vaginal progesterone administration provides a more easy-to-use and convenient method than IM progesterone administration for luteal phase support in IUI cycles with comparable pregnancy rates. [ABSTRACT FROM AUTHOR]

Background: The purpose of the current study was to assess if luteal support with intramuscular (IM) 17 alpha-hydroxyprogesterone caproate (17-OHPC) (Lentogest, IBSA, Italy) improves the pregnancy outcome in comparison to natural intramuscular progesterone (Prontogest, AMSA, Italy) when administered to recipients in a frozen embryo transfer cycle. Methods: A retrospective comparative study was performed to evaluate outcomes between two different intramuscular regimens used for luteal support in frozen embryo transfer cycles in patients underwent autologous in vitro fertilization (IVF) cycles (896 IVF cycles) and intracytoplasmic sperm injection (ICSI) who had a blastocyst transfer from February 2014 to March 2017 at the Centre for Reproductive and Genetic Health (CRGH) in London. Results: The live birth rates were significantly lower for the IM natural progesterone group when compared to 17-OHPC group (41.8% vs. 50.9%, adjusted OR of 0.63 (0.31-0.91)). The miscarriage rates were significantly lower in the 17-OHPC group compared to the IM natural progesterone group (14.5% vs. 19.2%, OR of 1.5, 95% CI of 1.13-2.11). The gestational age at birth and birth weight were similar in both groups (p=0.297 and p=0.966, respectively). Conclusion: It is known that both intramuscular and vaginal progesterone preparations are the standard of care for luteal phase support in women having frozen embryo transfer cycles. However, there is no clear scientific consensus regarding the optimal luteal support. In this study, it was revealed that live birth rates are significantly higher in women who received artificial progesterone compared to women who received natural progesterone in frozen embryo transfer cycles. [ABSTRACT FROM AUTHOR]

Introduction: Listeria monocytogenes is an etiological factor of listeriosis, widespread in the environment. The consequence of fetal infection in the second trimester of pregnancy in most cases is the death of the fetus or stillbirth. Material and methods: In this study, 7 strains of L. monocytogenes isolated from the vagina of women and the reference strain L. monocytogenes ATCC 19111 were used. The examined strains were treated with five commercially available intimate hygiene washes. The efficacy of the wash fluids used was based on the induced decrease in the number of bacteria expressed as a logarithmic colony-forming unit (CFU) × ml-1. Results: The study showed that probiotic fluid (pH = 3.5) decreased the number of bacteria by an average of 4.56 log CFU × ml-1, while wash fluid intended for pregnant and puerperal women (pH = 4.0) reduced the number of L. monocytogenes by an average of 1.55 log CFU × ml-1. Lower bactericidal efficacy was observed in the case of wash fluids intended for everyday use. The fluid containing marigold extract and the liquid with the addition of rice proteins and arnica extract decreased the number of L. monocytogenes by an average of 1.11 log CFU × ml-1, and the fluid with silver and copper nanoparticles by 1.14 log CFU × ml-1. Conclusions: Everyday use of intimate hygiene washes reduces the risk of urogenital infections in women and supports their treatment. Prevention with the use of probiotic wash solutions may reduce the number of vaginal infections caused by L. monocytogenes, which is especially important in the case of pregnant women because the number of patients diagnosed with listeriosis has increased. [ABSTRACT FROM AUTHOR]

Abstract: Intravaginal boric acid (IBA) represents one of the only options available to treat azole-resistant vulvovaginal candidiasis (VVC) and is included as part of multiple national guidelines (including the United Kingdom and the United States) for the treatment of VVC or recurrent bacterial vaginosis. Novel products using IBA are under development for treatment and suppression of VVC and bacterial vaginosis. Use of over-the-counter or clinician-prescribed IBA in reproductive-aged women is already widespread and may increase further if drug resistance in VVC rises. However, IBA is not a Food and Drug Administration-approved drug, and safety data are sparse. Given these factors, it is important to understand the currently available data on the safety of IBA use. Herein, we set out to synthesize human and animal data (converting, where appropriate, dose and serum values to standard units to facilitate comparison) to answer 2 key questions: (1) What are the data on the safety of IBA use for women? and (2) What are the data on the safety of IBA use in pregnancy? We find that, despite gaps, available data suggest IBA use is safe, at least when used in doses commonly described in the literature as being prescribed by clinicians. Information on harms in pregnancy is limited, and data remain insufficient to change current guidelines, which recommend IBA avoidance in pregnancy. [ABSTRACT FROM AUTHOR]

This study aimed to assess the validity and efficacy of blue dye in colposcopic assessment of genital injury in pre- and postmenopausal women with and without history of consensual sexual intercourse. Two hundred women were prospectively enrolled and examined colposcopically with and without toluidine blue dye in order to detect and categorize genital lesions (laceration, bruise and abrasion). Examination of genital trauma was accomplished in a standardized way and findings were photo documented. A wide range of influencing factors with a potential impact on prevalence and nature of genital injury was recorded beforehand using a questionnaire. The frequency of diagnostic injury differed substantially depending on the examination technique, ranging from 9% using colposcopic magnification only to 28% with the additional use of toluidine blue dye. A vertical laceration affecting the posterior fourchette was the most frequent lesion detected (17%, n = 32). Menopausal status seems to have significant impact on genital injury prevalence (p = 0.0165), as 42% (16/ 38) of postmenopausal compared to 24% (36/ 151) of premenopausal women had at least one genital lesion. Furthermore, vaginal medication (p = 0.0369), vaginal dryness (p = 0.0228), dyspareunia (p = 0.0234) and low frequency of sexual intercourse (p = 0.0022) were found to significantly correlate with the presence of genital lesions. According to our findings, standardized colposcopy in combination with toluidine blue dye facilitates accurate assessment of genital lesions. Genital trauma situated at another site than the posterior part of the vaginal introitus seems to be uncommon after consensual intercourse. [ABSTRACT FROM AUTHOR]