Mifepristone for miscarriage treatment in Utah: A survey of clinician knowledge and assessment of an educational video on future use.

Objectives: We aimed to: (a) describe current use of mifepristone for early pregnancy loss (EPL) management in Utah, (b) identify predictors of knowledge pre- and posteducational video, and (c) explore postvideo impacts on the likelihood to use mifepristone. Mifepristone is subject to the Food and Drug Administration's (FDA) Risk Evaluation and Mitigation Strategy (REMS) requirements. Methods: Between September 2020 and March 2021 we surveyed Utah clinicians from six specialties caring for people experiencing EPL, recruited through professional organizations and hospital listservs. Participants viewed a 3.5-minute educational video on mifepristone for EPL and completed pre- and postvideo questionnaires. We evaluated predictors of high prevideo and improved postvideo knowledge using random forest regression conditional importance measures and partial dependency plots. We described current mifepristone use and video effects on likelihood to use mifepristone. Results: Of 506 participants, most specialize in emergency medicine (172, 34%) and practice in private settings (253, 51%). Two-thirds had heard of mifepristone (328/471, 70%). Of 176/471 (37%) attempting provision of mifepristone, actual provision occurred for 59% (104/176). Baseline knowledge scores were low (mean 4.81/13 [37%] correct). Predictors of high prevideo knowledge include provision or attempted provision of mifepristone, having heard of mifepristone, providing EPL management expectantly or via medication, and specialty type. Mean postvideo knowledge scores improved by 3.27 points (68% improvement, paired t-test; 95% confidence interval 2.82-3.72, p < 0.0001). Postvideo, 66% (242/364) stated they are much more or somewhat more likely to use mifepristone, with compliance with FDA requirements cited as a barrier to utilization. Conclusions: Among Utah providers, baseline mifepristone knowledge and use for EPL management are low. An educational video improved knowledge and likelihood of use, but FDA REMS requirements continue to be a barrier to including mifepristone in medication management of EPL.

Quantitative and qualitative impact of One Key Question on primary care providers' contraceptive counseling at routine preventive health visits.

OBJECTIVES: One Key Question (OKQ) is a clinical screening tool to assess pregnancy desire in the next year. We aimed to 1) describe the effect of OKQ implementation on contraceptive counseling rates at preventive health visits and 2) evaluate primary care providers' perception of OKQ implementation on their contraceptive counseling practices. STUDY DESIGN: We performed a quantitative retrospective chart review of preventive health visits at eight federally qualified health centers in Utah between 2014 and 2017. Implementation of OKQ included a brief training and inclusion of OKQ in the electronic medical record. Providers received OKQ training in August 2015 and re-training in March 2017. We assessed OKQ and contraceptive counseling documentation rates using interrupted-time-series analysis. We then conducted semi-structured interviews with providers and queried them about the impact of OKQ. We identified dominant themes using modified grounded theory to create an explanatory framework. RESULTS: Abstracting 6634 charts yielded 9840 visits with 56 unique providers (51% physician assistant, 34% physician, 14% nurse practitioner). Interrupted-time-series analysis showed a documentation increase of OKQ in late 2015 (2.6%) and again in spring 2017 (9%), however rates remained low. Contraceptive counseling rates (39.7%) did not change after OKQ implementation. Charts with evidence of a current contraceptive method were less likely to have a OKQ response documented. Interviewees reported OKQ's algorithm did not alter their contraceptive counseling. CONCLUSIONS: OKQ did not change documented rates of contraceptive counseling and uptake was low in quantitative and qualitative analyses. Our study suggests limited usefulness of OKQ in the primary care setting. IMPLICATIONS: Implementation of the One Key Question tool through training and optional EHR field did not increase documented rates of contraceptive counseling in a large federally qualified health center or affect provider contraceptive counseling. Our study suggests limited usefulness of OKQ as a robust screening tool in this primary care setting.

Dose-finding study of a 90-day contraceptive vaginal ring releasing estradiol and segesterone acetate.

OBJECTIVE: To evaluate serum estradiol (E2) concentrations during use of 90-day contraceptive vaginal rings releasing E2 75, 100, or 200 mcg/day and segesterone acetate (SA) 200 mcg/day to identify a dose that avoids hypoestrogenism. STUDY DESIGN: We conducted a multicenter dose-finding study in healthy, reproductive-aged women with regular cycles with sequential enrollment to increasing E2 dose groups. We evaluated serum E2 concentrations twice weekly for the primary outcome of median E2 concentrations throughout initial 30-day use (target ≥40 pg/mL). In an optional 2-cycle extension substudy, we randomized participants to 2- or 4-day ring-free intervals per 30-day cycle to evaluate bleeding and spotting based on daily diary information. RESULTS: Sixty-five participants enrolled in E2 75 (n = 22), 100 (n = 21), and 200 (n = 22) mcg/day groups; 35 participated in the substudy. Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL. In the 200 mcg/day group, median E2 concentrations peaked on days 4-5 of CVR use at 194 pg/mL (range 114-312 pg/mL) and remained >40 pg/mL throughout 30 days; E2 concentrations were 37 pg/mL (range 28-62 pg/mL) on days 88-90 (n = 11). Among the E2 200 mcg/day substudy participants, all had withdrawal bleeding following ring removal. The 2-day ring-free interval group reported zero median unscheduled bleeding and two (range 0-16) and three (range 0-19) unscheduled spotting days in extension cycles 1 and 2, respectively. The 4-day ring-free interval group reported zero median unscheduled bleeding or spotting days. CONCLUSIONS: Estradiol concentrations with rings releasing E2 200 mcg/day and SA 200 mcg/day avoid hypoestrogenism over 30-day use. IMPLICATIONS: A 90-day contraceptive vaginal ring releasing estradiol 200 mcg/day and segesterone acetate 200 mcg/day achieves estradiol concentrations that should avoid hypoestrogenism and effectively suppresses ovulation.

Vaginal microbiome changes with levonorgestrel intrauterine system placement.

OBJECTIVE: To investigate changes in female genital tract bacterial ecology associated with levonorgestrel intrauterine system (LNG IUS) use. STUDY DESIGN: Study participants were regularly cycling Caucasian women without recent history of pregnancy or exogenous hormone use. Vaginal, cervical and uterine samples were obtained at nine time intervals, from 1 week before to 12 weeks after LNG IUS placement. Replicate paired vaginal and cervical specimens were collected to determine the consistency of specimen collection and processing. RESULTS: A total of 406 samples from 11 women were available for analysis after DNA extraction, amplification and species identification. Of the 355 bacterial species or genera detected, Lactobacillus crispatus was most prevalent representing 48.9% of over 6 million total reads. L. crispatus reads of replicate vaginal samples were not significantly different [odds ratio (OR) 0.79, 0.36-1.73]. In addition, L. crispatus reads of vaginal and cervical samples from the same visit were not significantly different (OR 0.69, 0.31-1.51). Compared to sampling visits prior to LNG IUS placement, sampling visits after LNG IUS insertion were more likely to have L. crispatus reads greater than 50% of total reads (OR 2.13, 1.01-4.48). Of the 63 uterine samples demonstrating bacteria, Burkholderia genus proteobacteria, a common environmental contaminant, were most prevalent both before and after LNG IUS insertion accounting for 48.0% of all uterine sample reads. CONCLUSION: The vaginal microbiome changes very little in response to LNG IUS placement. Further study is needed to place this finding in context with clinical outcomes. IMPLICATIONS: There do not appear to be any clinically important differences in the vaginal microbiome in response to insertion of the LNG IUS.

Criterion-based screening for sexually transmitted infection: sensitivity, specificity, and predictive values of commonly used questions.

INTRODUCTION: Practice protocols that mandate prescreening for sexually transmitted infection prior to insertion of an intrauterine device for contraception can pose obstacles for women seeking this highly effective method of birth control. Some practices screen for presumed risk factors for sexually transmitted infection in order to identify those who may be infected or those in whom laboratory testing should be obtained. The value of such criterion-based screening is unclear. METHODS: Data from a prospective observational trial of offering the copper intrauterine device for emergency contraception were used to assess the value of several screening questions in predicting the presence of sexually transmitted infection. Criteria evaluated were age under 25 years, history of a sexually transmitted infection, and having 2 or more sexual partners in the previous 3 months. The sensitivity, specificity, and likelihood ratio of both positive and negative test results and positive and negative predictive values were calculated for 3 separate questions as well as for combinations of these 3 questions. RESULTS: There were 197 women who received a copper intrauterine device for emergency contraception at the same time they were tested for sexually transmitted infection. In this sample, there were 8 cases of Chlamydia trachomatis identified and no cases of Neisseria gonorrhoeae. The sensitivity of individual and combined questions in identifying those who were infected ranged from 0% to 88%; specificity ranged from 37% to 97%. The positive predictive values for single or combined screening questions were in the range of 4% to 6%. Likelihood ratios for both positive and negative test results did not change posttest likelihood of disease in any appreciable way. DISCUSSION: Standard screening questions used to identify sexually transmitted infection risk could presume infection in large numbers of uninfected women and are of little value in identifying the women who are truly infected.

Operative management of intrauterine device complications: a case series report.

BACKGROUND: There is limited information about the number of intrauterine device (IUD) users requiring operative intervention for device-related complications. This is an evaluation of cases requiring in-hospital operative intervention for IUD perforations, removals and pregnancy-related complications. STUDY DESIGN: Large retrospective case series of patients who received operative management of IUD complications. RESULTS: Charts of patients from 15 hospitals in two health care systems from 2000 to 2007 were reviewed and outcomes of 276 women are reported. There were 95 operative IUD removals for perforations (including 60 levonorgestrel-releasing intrauterine systems), 157 operative procedures for inability to remove an IUD in the office, and 42 pregnancy-related complications that were managed in the operating room. Ectopic pregnancy was the most common diagnosis among pregnant women (23 of 42 pregnant women, 54.8%). CONCLUSION: The majority of operative procedures were performed for intrauterine IUDs, most of which were appropriately positioned IUDs with missing or short strings. In-office techniques for obtaining analgesia and dilation as well as appropriate devices for removal of T-shaped IUDs should make this practice rare.