Assessment of the Effectiveness of the Vaginal Contrast Media in Magnetic Resonance Imaging for Detection of Pelvic Pathologies: A Meta-analysis.

OBJECTIVE: Magnetic resonance imaging (MRI) is an excellent modality for pelvic imaging. The anatomy of uterine cavity and vagina is optimally evaluated when the walls, which may spontaneously be collapsed, are distended. Distension of these cavities during pelvic MRI for evaluation of gynecologic diseases has been conducted with vagina, filled with ultrasound gel or saline solution. In this meta-analysis, we aim to assess the effectiveness of vaginal contrast media in MRI for improving the detection of pelvic pathologies. METHODS: The PubMed, MEDLINE, EMBASE, Web of Science, Google Scholar, Science Citation Index, and Cochrane Library databases were systematically searched through March 2019 for studies of the accuracy of MRI using vaginal contrast media in the diagnosis and staging of pelvic pathologies. Four eligible studies of a total of 120 patients were included in the meta-analysis. The sensitivity rates and relative risk for MRI, before and after vaginal contrast medium administration, were pooled, and their 95% confidence intervals (CIs) were determined. RESULTS: The pooled sensitivity rate for MRI before administering intravaginal contrast medium in detecting pelvic pathologies was 63% (95% CI, 54%-72%), and that after was 89% (95% CI, 83%-93%). The interstudy heterogeneity rate (assessed using the I statistic) was relatively low: 13% (P = 0.33) and 0% (P = 0.45) before and after vaginal contrast medium use, respectively. The average relative risk was 1.54 (SD, 0.22; 95% CI, 1.18-1.89; median, 1.50; range, 1.34-1.80). This demonstrated that, on average, the sensitivity rate for MRI in detecting pelvic disorders increased by 54% after the use of a vaginal contrast medium. CONCLUSIONS: Use of vaginal contrast media improved the diagnostic ability of MRI in identifying pelvic pathologies.

Induction of labor using prostaglandin vaginal gel: cost analysis comparing early amniotomy with repeat prostaglandin gel.

BACKGROUND: In a randomized controlled trial of two policies for induction of labor (IOL) using Prostaglandin E2 (PGE2) vaginal gel, women who had an earlier amniotomy experienced a shorter IOL-to-birth time. OBJECTIVE: To report the cost analysis of this trial and determine if there are differences in healthcare costs when an early amniotomy is performed as opposed to giving more PGE2 vaginal gel, for women undergoing IOL at term. STUDY DESIGN: Following an evening dose of PGE2 vaginal gel, 245 women with live singleton pregnancies, ≥37+0 weeks, were randomized into an amniotomy or repeat-PGE2 group. Healthcare costs were a secondary outcome measure, sourced from hospital finance systems and included staff costs, equipment and consumables, pharmacy, pathology, hotel services and business overheads. A decision analytic model, specifically a Markov chain, was developed to further investigate costs, and a Monte Carlo simulation was performed to confirm the robustness of these findings. Mean and median costs and cost differences between the two groups are reported, from the hospital perspective. RESULTS: The healthcare costs associated with IOL were available for all 245 trial participants. A 1000-patient cohort simulation demonstrated that performing an early amniotomy was associated with a cost-saving of $AUD289 ($AUD7094 vs $AUD7338) per woman induced, compared with administering more PGE2. Propagating the uncertainty through the model 10,000 times, early amniotomy was associated with a median cost savings of $AUD487 (IQR -$AUD573, +$AUD1498). CONCLUSIONS: After an initial dose of PGE2 vaginal gel, a policy of administering more PGE2 when the Modified Bishop's score is <7 was associated with increased healthcare costs compared with a policy of performing an amniotomy, if technically possible. Length of stay was the main driver of healthcare costs.

Women's preferences toward attributes of local estrogen therapy for the treatment of vaginal atrophy.

OBJECTIVES: Decreased estrogen production due to menopause is often associated with vaginal atrophy, and estrogen therapy is the most effective treatment for the management of this condition. This study investigated women's preferences relating to various aspects of local estrogen therapy (LET) for the treatment of postmenopausal vaginal atrophy. STUDY DESIGN: The study involved 423 women aged >50 years who were resident in Sweden, had experienced menopausal changes in and around the vagina, and had used LET for these changes. The women completed an online questionnaire. MAIN OUTCOME MEASURES: The questionnaire involved a discrete choice experiment to determine women's willingness to pay for different characteristics of therapy. Time of LET appliance, use of disposable applicators with small tablets compared with both dosing syringes with vaginal cream and vagitories, and therapy that did/did not cause smudges/leakage were all considered. RESULTS: The women had no significant preference as to the time of day LET should be used. However, quantifying other preferences suggested that respondents were willing to pay € 66.58 or € 60.32 per month extra for using disposable applicators with small tablets rather than dosing syringes with vaginal cream or vagitories, respectively, and to avoid smudges/leakage. CONCLUSIONS: This survey suggests that women may prefer using disposable applicators with small tablets to deliver LET and value therapy that does not cause smudges/leakage. It is possible that if women are able to use their preferred form of LET, improved uptake or adherence of such medication may enhance the management of postmenopausal vaginal atrophy.

An assessment of the likely acceptability of vaginal microbicides for HIV prevention among women in rural Ghana.

BACKGROUND: The findings of the CAPRISA tenofovir studies have raised expectations that soon an approved microbicide would be available. However it is in only a limited number of countries in sub-Saharan Africa that the acceptability of microbicides has been evaluated. We conducted a study to assess the acceptability of vaginal microbicides among women in rural Ghana. METHODS: The study employs a mixed method design, using cross-sectional survey and focus group discussions to further understand issues related to awareness and attitudes towards microbicide development, acceptability and perceived partner attitudes among pregnant women attending antenatal clinic in two health facilities in the Kintampo North municipality of Ghana. We used logistic regression to identify possible predictors of microbicide acceptability among the women surveyed. RESULTS: Although only 2% of the 504 women were aware of the development of microbicides, 95% were willing to use one when it became available. The cost of a microbicide that will be considered affordable to 50% of women was US$0.75. Although there were concerns about possible wetting effect, gel or creams were the most preferred (68% of women) formulation. Although 71% thought their partners will find microbicide acceptable, apprehensions about the feasibility of and consequences of failed discreet use were evident. 49% of women were concerned about possible negative effect of microbicide on sexual pleasure. Perceived partner acceptability (O.R. =17.7; 95%C.I. 5.03-62.5) and possibility of discreet use (O.R. =8.9 95%C.I. 2.63-30.13) were the important predictors of microbicide acceptability. CONCLUSION: Achieving microbicide acceptability among male partners should be made a part of the promotive interventions for ensuring effective use among women in rural Ghana.

What predicts non-retention in microbicide trials?

BACKGROUND: Poor retention can reduce study power and thwart randomization, possibly resulting in biased estimates of effect. Some HIV prevention trials conducted in developing countries have been challenged by high loss to follow-up. Identifying factors associated with non-retention could lead to recruitment of women more likely to remain in the trial, potentially yielding greater efficiency and validity. METHODS: We summarized retention rates and, using Cox regression, evaluated factors associated with non-retention in four trials of two candidate vaginal microbicides (1% C31G or SAVVY® and 6% cellulose sulfate or CS) conducted in multiple sub-Saharan African countries. We defined retention as completion of the trial, including those with an HIV outcome. Non-retention comprised participants randomized to a study arm who were either lost to follow-up or discontinued prior to infection with HIV. RESULTS: 7,367 women were enrolled and randomized in the four trials; 7,086 are included in this analysis. 1,514 (21.4%) participants were either lost to follow-up or had early discontinuation. In the final Cox model, the following baseline factors were associated with non-retention: younger age (hazard ratio [HR] = 0.95); less education (HR = 0.97); condom use at last sex (HR = 1.18); larger number of sex acts in a typical week (HR = 1.01); and baseline candidiasis or bacterial vaginosis (HR = 1.12). CONCLUSIONS: Younger and less educated women were more difficult to retain in these microbicide trials. But these same traits may be associated with higher HIV infection rates. Enhanced retention methods focused on those at highest risk of non-retention and possibly infection will optimize study efficiency and validity.