Multi-criteria decision analysis: technique for order of preference by similarity to ideal solution for selecting greener analytical method in the determination of mifepristone in environmental water samples.

This work proposes the use of multi-criteria decision analysis (MCDA) to select a more environmentally friendly analytical procedure. TOPSIS, which stands for Technique for Order of Preference by Similarity to Ideal Solution, is an example of a MCDA method that may be used to rank or select best alternative based on various criteria. Thirteen analytical procedures were used in this study as TOPSIS input choices for mifepristone determination in water samples. The input data, which consisted of these choices, was described using assessment criteria based on 12 principles of green analytical chemistry (GAC). Based on the objective mean weighting (MW), the weights for each criterion were assigned equally. The most preferred analytical method according to the ranking was solid phase extraction with micellar electrokinetic chromatography (SPE-MEKC), while solid phase extraction combined with ultra-high performance liquid chromatography tandem mass spectrometry (SPE-UHPLC-MS/MS) was ranked last. TOPSIS ranking results were also compared to the green metrics NEMI, Eco-Scale, GAPI, AGREE, and AGREEprep that were used to assess the greenness of thirteen analytical methods for mifepristone determination. The results demonstrated that only the AGREE metric tool correlated with TOPSIS; however, there was no correlation with other metric tools. The analysis results suggest that TOPSIS is a very useful tool for ranking or selecting the analytical procedure in terms of its greenness and that it can be easily integrated with other green metrics tools for method greenness assessment.

Evaluation of a "smart" screening tool for asynchronous assessment of medication abortion eligibility: A pilot study.

OBJECTIVES: This study aimed to assess the feasibility, safety, and acceptability of asynchronous screening for medication abortion eligibility using a programmed questionnaire. STUDY DESIGN: For this study, we developed an informational website about medication abortion with a linked questionnaire programmed to produce a conclusion regarding eligibility according to standard criteria. We enrolled people in Colorado and Minnesota who submitted questionnaires indicating eligibility. A study physician reviewed each questionnaire and medical records if available and determined whether the responses warranted treatment without a synchronous clinical consultation or ultrasound. If so, the physician prescribed a standard regimen of mifepristone and misoprostol. We collected posttreatment data on abortion outcome, adverse events, and satisfaction. RESULTS: We received questionnaires from 197 individuals, of whom 160 remained in the study until the physician made a final treatment decision. Physicians prescribed medication abortion to 156 (97.5%) individuals based on the questionnaire responses, whereas four needed further assessment to confirm eligibility. Of the 156 individuals, 130 had sufficient follow-up to assess abortion outcome, and 123 (95%) had complete medication abortions without additional treatment. One participant was hospitalized for bleeding, and one expelled a 15-week fetus; however, it is not clear that conventional synchronous history-based screening would have averted these events. Of the 197 questionnaires, 42% were submitted outside business hours. On satisfaction questionnaires, 134 (96%) of 144 participants said they would recommend the study to a friend who needed an abortion. CONCLUSIONS: Data from this pilot project suggest that providing medication abortion based only on a self-administered, programmed questionnaire is likely to be effective, safe, efficient, and acceptable. IMPLICATIONS: A programmed self-administered patient questionnaire to assess eligibility for medication abortion could reduce the cost of the service, augment clinic efficiency, improve quality of care, and enhance access to abortion.

Explaining the Fifth Circuit Court of Appeals Ruling on Mifepristone Access.

This Viewpoint summarizes the Fifth Circuit Court of Appeals ruling on access to mifepristone, the first of 2 pills used in medication abortion.

Canadian Newspapers Support Mifepristone Medication Abortion to Improve Fulfillment of the AAAQ Right to Health Framework (2015-2019).

BACKGROUND: In 2015, mifepristone in combination with misoprostol, the international gold standard for medication abortion, was approved for use in Canada. By 2019, all Canadian provinces had included the medication as a publicly insured health benefit. METHODS: Our content analysis of Canadian newspaper coverage describes arguments in favor of or against medication abortion and the evolving regulatory framework for mifepristone from 6 months before regulatory approval until the last significant regulatory barrier to use was removed (2015-2019). RESULTS: Our study found an exceptionally high level of support for the approval of, introduction of, and removal of regulatory barriers to mifepristone for medication abortion. Of 402 pieces, 67% were pro-medication abortion, 25% presented balanced or neutral coverage, and only 8% presented solely anti-medication abortion viewpoints. Of the 761 individuals quoted, more than 90% made positive or neutral statements about medication abortion. Most pieces discussed medication abortion as a health issue and described how liberalization of the regulatory framework would improve abortion availability (68%), accessibility (87%), acceptability (34%), and quality (28%). CONCLUSIONS: Rather than formal balance, which presents contrasting arguments as equally valid even when the scientific evidence for one vastly outweighs the other, our study identified evidentiary balance, in which coverage aligned with the weight of evidence and expert opinion. Our results differ from analyses in other high-income countries (United Kingdom, United States) where media outlets frame abortion in relation to morality or electoral politics rather than as a health issue. The Canadian print media presented overwhelmingly favorable arguments toward the expansion of mifepristone medication abortion and framed the introduction and universal coverage of medication abortion as advancing the "Availability, Accessibility, Acceptability, and Quality" (AAAQ) Right to Health Framework that establishes international human rights standards for health information, facilities, goods, and services.

Approved but Unavailable: A Mystery-Caller Survey of Mifepristone Access in a Large Ontario City.

OBJECTIVES: Mifepristone/misoprostol (mife/miso) has been approved in Canada since 2017, and is available since 2018. Mife/miso does not require witnessed administration in Canada, and therefore most patients obtain a prescription for home use. We sought to determine the proportion of pharmacies in Hamilton, Ontario, Canada, a city of over 500 000, that had combination mife/miso in stock at any given time. METHODS: A mystery-caller approach was used to survey all pharmacies (n = 218) in Hamilton, Ontario, Canada between June 2022 and September 2022. RESULTS: Of the 208 pharmacies that were successfully contacted, only 13 (6%) pharmacies had mife/miso in stock. The most commonly cited reasons for the medication being unavailable were low patient demand (38%), cost (22%), lack of familiarity with medication (13%), supplier issues (9%), training requirements (8%), and medication expiry (7%). CONCLUSIONS: These findings suggest that while mife/miso has been available in Canada since 2017, significant barriers remain to patients accessing this medication. This study clearly demonstrates a need for further advocacy and clinician education to ensure mife/miso is accessible to the patients who require it.

Implications of using home urine pregnancy tests versus facility-based tests for assessment of outcome following medication abortion provided via telemedicine.

OBJECTIVES: To assess whether planning high-sensitivity urine pregnancy tests (HSPT) rather than facility-based tests for medication abortion follow-up may increase risk of unplanned clinical visits or procedural completion of the abortion. STUDY DESIGN: We used data from the TelAbortion Project, a 5-year study assessing the safety and feasibility of providing mifepristone and misoprostol by telemedicine and mail in the United States. We categorized participants by whether the pretreatment follow-up plan included HSPT at home 3-5 weeks after treatment or facility-based tests (ultrasound or serum human chorionic gonadotropin) within 2 weeks after treatment. We used multivariable logistic regression to compare likelihood of post-treatment unplanned, abortion-related clinical visits and procedural intervention in these groups. RESULTS: Of 1324 patients who planned HSPT follow-up and 576 who planned facility-based tests, 85% and 83%, respectively, provided outcome information. Post-treatment clinical visits were less frequent in the HSPT group (19%) than in the facility-based test group (79%); most of the latter were to obtain the planned test. However, unplanned, abortion-related visits were significantly more common in the HSPT group (adjusted risk difference: 6.5%; p < 0.01). The likelihood of procedural completion did not differ by group. Planned follow-up test was not associated with delay in procedural completion or detection of ongoing pregnancy. CONCLUSIONS: Follow-up of medication abortion with home HSPT was associated with fewer post-treatment clinical visits, modestly more unplanned, abortion-related clinical visits, and no increase in the risk of procedural interventions or delayed identification or management of treatment failures. This option is an appropriate follow-up approach after medication abortion. IMPLICATIONS: Use of home high-sensitivity pregnancy tests rather than facility-based tests for outcome assessment after medication abortion is associated with a modest increase in unplanned clinical visits but does not lead to an increase in procedural interventions or delays identification and management of treatment failure.

Availability of medical abortion medicines in eight countries: a descriptive analysis of key findings and opportunities.

BACKGROUND: In recent years a growing number of manufacturers and medical abortion products have entered country markets and health systems, with varying degrees of quality and accessibility. An interplay of factors including pharmaceutical regulations, abortion laws, government policies and service delivery guidelines and provider's knowledge and practices influence the availability of medical abortion medicines. We assessed the availability of medical abortion in eight countries to increase understanding among policymakers of the need to improve availability and affordability of quality-assured medical abortion products at regional and national levels. METHODS: Using a national assessment protocol and an availability framework, we assessed the availability of medical abortion medicines in Bangladesh, Liberia, Malawi, Nepal, Nigeria, Rwanda, Sierra Leone and South Africa between September 2019 and January 2020. RESULTS: Registration of abortion medicines-misoprostol or a combination of mifepristone and misoprostol-was established in all countries assessed, except Rwanda. Mifepristone and misoprostol regimen for medical abortion was identified on the national essential medicines list/standard treatment guidelines for South Africa as well as in specific abortion care service and delivery guidelines for Bangladesh, Nepal, Nigeria, and Rwanda. In Liberia, Malawi, and Sierra Leone-countries with highly restrictive abortion laws and no abortion service delivery guidelines or training curricula-no government-supported training on medical abortion for public sector providers had occurred. Instead, training on medical abortion was either limited in scope to select private sector providers and pharmacists or prohibited. Community awareness activities on medical abortion have been limited in scope across the countries assessed and where abortion is broadly legal, most women do not know that it is an option. CONCLUSION: Understanding the factors that influence the availability of medical abortion medicines is important to support policymakers improve availability of these medicines. The landscape assessments documented that medical abortion commodities can be uniquely impacted by the laws, policies, values, and degree of restrictions placed on service delivery programs. Results of the assessments can guide actions to improve access.

Unsafe abortion is a leading cause of death and disability among women of reproductive age. Medical management of abortion with mifepristone and misoprostol pills, or just misoprostol, is a safe and effective way to end a pregnancy. Owing to an increase in the number of medical abortion products that have entered country health systems, we examined access to these medicines from supply to demand in selected countries. The overarching goal of the national landscape assessments was to produce evidence to support advocacy efforts and policymaking for improved access to quality medical abortion products that is appropriate to the needs of the country. This paper aims to describe key findings across eight country settings on the availability of medical abortion medicines and identify key opportunities to improve access to them across countries.

Advance provision of medication for induced abortion: A qualitative study of patient perspectives.

OBJECTIVES: To examine potential users' perspectives regarding the provision of abortion medications for future use or "advance provision." STUDY DESIGN: In this qualitative study, we partnered with an independent reproductive health care clinic in Washington State to conduct semistructured, in-depth interviews with 22 individuals who obtained a medication abortion between August 2021 and January 2022. We asked participants their views on advance provision of abortion medications. Interviews were transcribed and deidentified. Inductive content analysis was used to identify major themes. RESULTS: Participants in our sample generally reacted positively to the idea of abortion medications for future use. Having pills in advance could improve timeliness and convenience of care and decrease the stigma associated with their use. Participants stressed the importance of adequate information regarding medication use, what to expect, and potential side effects. Most concerns about advance provision related to the safety and efficacy of medication abortion. CONCLUSIONS: This study found that individuals who recently obtained a medication abortion supported the provision of abortion medications for future use. IMPLICATIONS: Patient-centered educational materials, with adequate information for self-managing pregnancy termination, can be shared at time of prescription. Clinicians have an opportunity to offer these safe and effective medications in advance of need and increase timely access to this essential health care service. User concerns regarding abortion medications for future use should inform clinical innovation and evaluative research of service options.

At-home urine pregnancy test assessment after mifepristone and misoprostol for undesired pregnancy of unknown location.

OBJECTIVES: The ideal assessment after mifepristone and misoprostol for undesired pregnancy of unknown location (PUL) is unknown. STUDY DESIGN: We prospectively followed patients at Planned Parenthood League of Massachusetts (2019-2021) with PUL who received immediate mifepristone and misoprostol with serial at-home urine pregnancy tests (UPT) and in-office serum HCGs. RESULTS: Of 13 patients, 10 had a successful medication abortion. For those who completed UPTs (N = 9), all were negative by Day 14. Two abnormal pregnancies had positive UPTs on Day 14. CONCLUSION: A negative UPT on Day 14 may help determine complete abortion after medication abortion for undesired PUL. A positive UPT on Day 14 warrants further evaluation. IMPLICATION: Patients taking mifepristone and misoprostol in the setting of undesired PUL who cannot access serum testing may consider an at-home UPT to confirm complete abortion.

Protective assessment of progesterone and its receptor on experimental diabetic neuropathy: Antioxidant and anti-inflammatory effects.

Diabetes induces a disorder in mitochondrial activity, which causes damage to the nuclear and mitochondrial DNA and ultimately increases the release of inflammatory cytokines and damages the sciatic nerve and dorsal root ganglion and induces neuropathy. It has been shown that progesterone has anti-inflammatory and antioxidative effects and prevents nerve cell damage. Therefore, the aim of this experiment was to investigate the effect of progesterone receptor neuroprotection on diabetic neuropathy. Forty male Sprague-Dawley rats were divided into four groups, including control group, diabetic control group, diabetic control group + progesterone (30 mg/kg), and diabetic control group + combination of progesterone (30 mg/kg) and RU486 (10 mg/kg). After the induction of diabetes, blood glucose level, body weight, behavioral tests, electrophysiological tests, oxidative and inflammatory factors, and histological parameters were measured. Progesterone treatment significantly reduced the level of sensitivity to hot plate without significant effect on glucose level, and significant changes were also observed in the results of tail flick test. In addition, the results showed that the administration of progesterone can improve MNCV and significantly reduce the serum levels of oxidative stress and inflammatory factors, as well as inflammation and edema around the sciatic nerve. However, RU486 inverted the beneficial effects of progesterone. Progesterone can be considered as a protective agent in reducing DN because of its ability to reduce inflammation and nerve damage. In addition, RU486, a progesterone receptor blocker, inhibits the beneficial effects of progesterone on the DN; thus, progesterone receptors play an important role in the neuroprotective effect of progesterone.

Predictor assessment of complete miscarriage after medical treatment for early pregnancy loss in women with previous cesarean section.

This study aimed to evaluate clinical predictors associated with complete miscarriage after medical treatment for early pregnancy loss (EPL) in women with previous cesarean section. Patients with retained uterine content after expulsion followed by administration of mifepristone and misoprostol were included if they chose continued medical treatment rather than surgical intervention. Clinical characteristics including maternal age, gravidity, parity, history of previous cesarean section and ultrasound findings regarding average diameter of the gestational sac, uterine position, width, and blood flow signal of the residual uterine content after expulsion of the gestational sac were included in the analysis to determine predictors of complete miscarriage. A recursive partitioning analysis (RPA) was used to divide the patients into probability groups and assess their probability of complete miscarriage. A total of 89 patients were analyzed. The complete miscarriage rate was 58.43% overall. Multivariable logistic regression analysis showed that the width and blood flow signal of the residual after expulsion were both independent predictors for complete miscarriage (all P < .05). Patients were divided into high-probability (no blood flow signal, width of residual <1 cm), intermediate-probability (no blood flow signal, width of residual ≥1 cm; blood flow signal, width of residual <1 cm), and low-probability (blood flow signal, width of residual ≥ 1 cm) groups by RPA according to these 2 factors. The incidences of complete miscarriage were 88.24%, 67.57%, and 34.29%, respectively, P < .001). Surgical evacuation may be avoided in patients without ultrasonic blood flow of the uterine residual and width of the residual <1 cm. More active treatment could be recommended for patients with ultrasonic blood flow of the uterine residual and width of the residual ≥ 1 cm. Clinicians and patients should be aware of these differences when proceeding with medical treatment for EPL patients with previous cesarean section.

First Trimester Miscarriage.

First trimester miscarriage, or early pregnancy loss, is a common occurrence in the United States. Miscarriage management includes expectant, medical, or surgical approaches. Decisions about management options should be approached through shared decision making between the patient and provider and with consideration of patient's preferences, hemodynamic stability, cost, gestational age, and effectiveness. Emergencies requiring immediate interventions are rare. Newer developments in management, including a more effective medical regimen with the addition of mifepristone and cost-effective and convenient in-office surgical interventions, have expanded treatment options.

Medical management of early pregnancy loss is cost-effective compared with office uterine aspiration.

BACKGROUND: Early pregnancy loss, also referred to as miscarriage, is common, affecting approximately 1 million people in the United States annually. Early pregnancy loss can be treated with expectant management, medications, or surgical procedures-strategies that differ in patient experience, effectiveness, and cost. One of the medications used for early pregnancy loss treatment, mifepristone, is uniquely regulated by the Food and Drug Administration. OBJECTIVE: This study aimed to compare the cost-effectiveness from the healthcare sector perspective of medical management of early pregnancy loss, using the standard of care medication regimen of mifepristone and misoprostol, with that of office uterine aspiration. STUDY DESIGN: We developed a decision analytical model to compare the cost-effectiveness of early pregnancy loss treatment with medical management with that of office uterine aspiration. Data on medical management came from the Pregnancy Failure Regimens randomized clinical trial, and data on uterine aspiration came from the published literature. The analysis was from the healthcare sector perspective with a 30-day time horizon. Costs were in 2018 US dollars. Effectiveness was measured in quality-adjust life-years gained and the rate of complete gestational sac expulsion with no additional interventions. Our primary outcome was the incremental cost per quality-adjust life-year gained. Sensitivity analysis was performed to identify the key uncertainties. RESULTS: Mean per-person costs were higher for uterine aspiration than for medical management ($828 [95% confidence interval, $789-$868] vs $661 [95% confidence interval, $556-$766]; P=.004). Uterine aspiration more frequently led to complete gestational sac expulsion than medical management (97.3% vs 83.8%; P=.0001); however, estimated quality-adjust life-years were higher for medical management than for uterine aspiration (0.082 [95% confidence interval, 0.8148-0.08248] vs 0.079 [95% confidence interval, 0.0789-0.0791]; P<.0001). Medical management dominated uterine aspiration, with lower costs and higher confidence interval. The probability that medical management is cost-effective relative to uterine aspiration is 97.5% for all willingness-to-pay values of ≥$5600/quality-adjust life-year. Sensitivity analysis did not identify any thresholds that would substantially change outcomes. CONCLUSION: Although office-based uterine aspiration more often results in treatment completion without further intervention, medical management with mifepristone pretreatment costs less and yields similar quality-adjust life-years, making it an attractive alternative. Our findings provided evidence that increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care.

Economic evaluation of a randomized controlled trial comparing mifepristone and misoprostol with misoprostol alone in the treatment of early pregnancy loss.

BACKGROUND: In case of early pregnancy loss (EPL) women can either choose for expectant, medical or surgical management. One week of expectant management is known to lead to spontaneous abortion in approximately 50% of women. Medical treatment with misoprostol is known to be safe and less costly than surgical management, however less effective in reaching complete evacuation of the uterus. Recently, a number of trials showed that prompt treatment with the sequential combination of mifepristone with misoprostol is superior to misoprostol alone in reaching complete evacuation. In this analysis we evaluate whether the sequential combination of mifepristone with misoprostol is cost-effective compared to misoprostol alone, in the treatment of EPL. METHODS AND FINDINGS: A cost-effectiveness analysis (CEA) from a healthcare perspective was performed alongside a randomised controlled trial (RCT) in which standard treatment with misoprostol only was compared with a combination of mifepristone and misoprostol, in women with EPL after a minimum of one week of unsuccessful management. A limited societal perspective scenario was added. This RCT, the Triple M trial, was a multicentre, randomized, double-blinded, placebo-controlled trial executed at 17 hospitals in the Netherlands. The trial started on June 27th 2018, and ended prematurely in January 2020 due to highly significant outcomes from the predefined interim-analysis. We included 351 women with a diagnosis of EPL between 6 and 14 weeks gestation after at least one week of unsuccessful expectant management. They were randomized between double blinded pre-treatment with oral mifepristone 600mg (N = 175) or placebo (N = 176) taken on day one, both followed by misoprostol orally. In both groups, an intention-to-treat analysis was performed for 172 patients, showing a significant difference in success rates between participants treated with mifepristone and misoprostol versus those treated with misoprostol alone (79.1% vs 58.7% respectively). In this cost-effective analysis we measured the direct, medical costs related to treatment (planned and unplanned hospital visits, medication, additional treatment) and indirect costs based on the IMTA Productivity Cost Questionnaire (iPCQ). Quality Adjusted Life Years (QALY's) were calculated from participants' scores on the SF-36 questionnaires sent digitally at treatment start, and one, two and six weeks later. We found medical treatment with placebo followed by misoprostol to be 26% more expensive compared to mifepristone followed by misoprostol (p = 0.001). Mean average medical costs per patient were significantly lower in the mifepristone group compared to the placebo group (€528.95 ± 328.93 vs €663.77 ± 456.03, respectively; absolute difference €134.82, 95% CI 50,46-219,18, p = 0.002). Both indirect costs and QALY's were similar between both groups. CONCLUSION: The sequential combination of mifepristone with misoprostol is cost-effective compared with misoprostol alone, for treatment of EPL after a minimum of one week of unsuccessful expectant management.

Mail-order pharmacy dispensing of mifepristone for medication abortion after in-person clinical assessment.

OBJECTIVE(S): To estimate the effectiveness, acceptability, and feasibility of medication abortion with mifepristone dispensed by a mail-order pharmacy after in-person clinical assessment. STUDY DESIGN: This is an interim analysis of an ongoing prospective cohort study conducted at five sites. Clinicians assessed patients in clinic and, if they were eligible for medication abortion and ≤ 63 days' gestation, electronically sent prescriptions for mifepristone 200 mg orally and misoprostol 800 mcg buccally to a mail-order pharmacy, which shipped medications for next-day delivery. Participants completed surveys three and 14 days after enrollment, and we abstracted medical chart data. RESULTS: Between January 2020 and April 2021 we enrolled 240 participants and obtained clinical outcome information for 227 (94.6%); 3 reported not taking either medication. Of those with abortion outcome information (N = 224), 216 (96.4%) completed day-3 and 212 (94.6%) day-14 surveys. Of the 224 that took medications, none reported taking past 70 days' gestation, and complete medication abortion occurred for 217 participants (96.9%, 95% CI 93.7%-98.7%). Most received medications within three days (82.1%, 95% CI 76.5%-86.9%). In the day-3 survey, 95.4% (95% CI 91.7%-97.8%) reported being very (88.4%) or somewhat (6.9%) satisfied with receiving medications by mail. In the day-14 survey, 89.6% (95% CI 84.7%-93.4%) said they would use the mail-order service again if needed. Eleven (4.9%, 95% CI 2.5%-8.6%) experienced adverse events; two were serious (one blood transfusion, one hospitalization), and none were related to mail-order pharmacy dispensing. CONCLUSIONS: Medication abortion with mail-order pharmacy dispensing of mifepristone appears effective, feasible, and acceptable to patients. IMPLICATIONS: The in-person dispensing requirement for mifepristone, codified in the drug's Risk Evaluation and Mitigation Strategy, should be removed.

Discovery of Novel GR Ligands toward Druggable GR Antagonist Conformations Identified by MD Simulations and Markov State Model Analysis.

Binding of different ligands to glucocorticoid receptor (GR) may induce different conformational changes and even trigger completely opposite biological functions. To understand the allosteric communication within the GR ligand binding domain, the folding pathway of helix 12 (H12) induced by the binding of the agonist dexamethasone (DEX), antagonist RU486, and modulator AZD9567 are explored by molecular dynamics simulations and Markov state model analysis. The ligands can regulate the volume of the activation function-2 through the residues Phe737 and Gln738. Without ligand or with agonist binding, H12 swings from inward to outward to visit different folding positions. However, the binding of RU486 or AZD9567 perturbs the structural state, and the passive antagonist state appears more stable. Structure-based virtual screening and in vitro bioassays are used to discover novel GR ligands that bias the conformation equilibria toward the passive antagonist state. HP-19 exhibits the best anti-inflammatory activity (IC50 = 0.041 ± 0.011 µm) in nuclear factor-kappa B signaling pathway, which is comparable to that of DEX. HP-19 also does not induce adverse effect-related transactivation functions of GR. The novel ligands discovered here may serve as promising starting points for the development of GR modulators.

Sonoelastography for the comparative assessment of cervical maturation after different approaches to cervical preparation ahead of labor induction.

AIM: To compare the efficacy of different approaches to cervical preparation to labor induction using the ultrasound cervical elastography. MATERIALS AND METHODS: This prospective open-label study included 200 pregnant women aged between 23 and 38 years eligible for labor pre-induction. Patients were divided into four groups (n = 50 per group). In Group I, four osmotic Dilapan-S cervical dilators combined with two doses of oral mifepristone (200 mg each) 24 h apart were used. The dilators were inserted for up to 12 h. In Group II, only the Dipalan-S dilators were used. In Group III, a Foley catheter was positioned intracervically for 12 h. In Group IV, we used two doses of intracervical prostaglandin E2 gel (0.5 mg each) 6 h apart. Cervical maturation was assessed using the Bishop scoring system and the ultrasound cervicometry with the color mapping and calculation of SR ratio. At baseline, all participants were also divided into three subgroups depending on the Bishop score before the pre-induction. Subgroup А (n = 66) included patients with the Bishop score between 0‒2 points, subgroup B (n = 69) between 3-4 points, and subgroup С (n = 65) between 4-6 points. RESULTS: Our study showed that the efficacy of Dilapan-S combined with mifepristone for cervical preparation to labor induction was higher than Dilapan-S, Foley catheter and intracervical prostaglandin E2 gel. In this group, the Bishop score after the pre-induction was the highest (11.4 (0.21) points versus 10.2 (0.2), 9.4 (0.3) и 9.67 (0.25) in Groups II, III and IV respectively (p < .05 for all). The lowest SR values were also observed among the patients receiving the combination of Dilapan-S and mifepristone: 1.23 (0.04) versus 1.63 (0.07), 1.7 (0.08) and 1.83 (0.1) in Groups II, III and IV respectively (p < .05 for all). The sonoelastographic SR values in subgroups B and C were statistically lower compared with subgroup A across all groups studied. Ultrasound elastography of the cervix allowed to perform a more objective assessment of cervical maturation compared with the Bishop scoring. CONCLUSION: Dilapan-S combined with mifepristone had higher efficacy for cervical preparation to labor induction compared with other approaches investigated.

Accuracy of self-assessment of gestational duration among people seeking abortion.

BACKGROUND: Mifepristone, used together with misoprostol, is approved by the United States Food and Drug Administration for medication abortion through 10 weeks' gestation. Although in-person ultrasound is frequently used to establish medication abortion eligibility, previous research demonstrates that people seeking abortion early in pregnancy can accurately self-assess gestational duration using the date of their last menstrual period. OBJECTIVE: In this study, we establish the screening performance of a broader set of questions for self-assessment of gestational duration among a sample of people seeking abortion at a wide range of gestations. STUDY DESIGN: We surveyed patients seeking abortion at 7 facilities before ultrasound and compared self-assessments of gestational duration using 11 pregnancy dating questions with measurements on ultrasound. For individual pregnancy dating questions and combined questions, we established screening performance focusing on metrics of diagnostic accuracy, defined as the area under the receiver operating characteristic curve, sensitivity (or the proportion of ineligible participants who correctly screened as ineligible for medication abortion), and proportion of false negatives (ie, the proportion of all participants who erroneously screened as eligible for medication abortion). We tested for differences in sensitivity across individual and combined questions using McNemar's test, and for differences in accuracy using the area under the receiver operating curve and Sidak adjusted P values. RESULTS: One-quarter (25%) of 1089 participants had a gestational duration of >70 days on ultrasound. Using the date of last menstrual period alone demonstrated 83.5% sensitivity (95% confidence interval, 78.4-87.9) in identifying participants with gestational durations of >70 days on ultrasound, with an area under the receiver operating characteristic curve of 0.82 (95% confidence interval, 0.79-0.85) and a proportion of false negatives of 4.0%. A composite measure of responses to questions on number of weeks pregnant, date of last menstrual period, and date they got pregnant demonstrated 89.1% sensitivity (95% confidence interval, 84.7-92.6) and an area under the receiver operating curve of 0.86 (95% confidence interval, 0.83-0.88), with 2.7% of false negatives. A simpler question set focused on being >10 weeks or >2 months pregnant or having missed 2 or more periods had comparable sensitivity (90.7%; 95% confidence interval, 86.6-93.9) and proportion of false negatives (2.3%), but with a slightly lower area under the receiver operating curve (0.82; 95% confidence interval, 0.79-0.84). CONCLUSION: In a sample representative of people seeking abortion nationally, broadening the screening questions for assessing gestational duration beyond the date of the last menstrual period resulted in improved accuracy and sensitivity of self-assessment at the 70-day threshold for medication abortion. Ultrasound assessment for medication abortion may not be necessary, especially when requiring ultrasound could increase COVID-19 risk or healthcare costs, restrict access, or limit patient choice.