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.

Trust in provider and stigma during second-trimester abortion.

OBJECTIVE: To determine whether trust in the provider and sociodemographics are associated with individual-level abortion stigma. METHODS: We performed a cross sectional and exploratory study design using secondary analysis of a randomized trial that enrolled participants undergoing second trimester abortion. We collected baseline survey data from 70 trial participants to assess stigma (Individual Level of Abortion Stigma scale, ILAS; range 0-4), trust in provider (Trust in Physician scale; range 1-5), anxiety, depression, and sociodemographics. We performed multiple linear regression, for which ILAS score was the outcome of interest. Univariate associations were used to inform the regression model. RESULTS: The mean abortion stigma score was at the low end of the ILAS at 1.21 (range 0.2-2.8, SD 0.66). Age, race, income, BMI, parity, gestational age at time of abortion, and reasons for ending the pregnancy were not significantly associated with the ILAS score. Higher trust in provider scores were (m 4.0, SD 0.49) and inversely related to the ILAS score, even after adjustment for confounders (ß -0.02, CI -0.03 to -0.004, p = 0.013). Screening positive for anxiety or depression was associated with a higher ILAS score ((ß 0.48, CI 0.10, 0.90, p = 0.015); (ß = 0.27 CI -0.097, 0.643)), while cohabitation was associated with lower ILAS score (ß -0.44, CI -0.82 to -0.57, p = 0.025). CONCLUSIONS: Trust in an abortion provider, anxiety, depression, and cohabitation are associated with abortion stigma among people seeking second trimester abortion care. Interventions that improve trust in a provider may be an area of focus for addressing abortion stigma. Future research should confirm these findings in larger populations and across diverse locations and demographics and to conduct qualitative research to understand what patients perceive as trust-promoting behaviors and words during abortion encounters.

Opioid prescription for pain after osmotic dilator placement in abortion care: A randomized controlled trial.

OBJECTIVE: To compare the overnight maximum pain scores after osmotic dilator placement prior to a dilation and evacuation (D&E) procedure in participants assigned to a prescription for ibuprofen alone or to ibuprofen plus oxycodone. STUDY DESIGN: We conducted a nonblinded pragmatic, randomized controlled trial to evaluate pain management among women undergoing osmotic dilator placement prior to D&E. We randomly assigned 70 participants at 12 weeks 6 days to 23 weeks 6 days gestation to receive a prescription for ibuprofen alone, or ibuprofen plus oxycodone. We assessed pain using a numeric rating scale (NRS; scale 0-10) at the following time points: Baseline, dilator placement, 2 and 6 hours, and preoperatively, where we also asked participants their maximum pain score. The primary outcome was mean individual NRS pain score change from baseline to maximum pain score. RESULTS: Maximum mean pain score (change from baseline) was 4.7 ± 2.9 in the ibuprofen group, and 6.5 ± 2.5 in the ibuprofen plus oxycodone group (p < 0.01). Participants in both groups reported highest NRS pain scores 2 hours after dilator placement, 3.9 ± 2.5 and 5.3 ± 2.6 respectively (p = 0.02). Average ibuprofen use in both arms was similar, and 81% of participants used at least 1 dose of ibuprofen after dilator placement. Of those randomized to prescription to ibuprofen plus oxycodone, only 51% used a dose of oxycodone. CONCLUSIONS: Compared to participants randomized to receive a prescription for ibuprofen, those randomized to receive a prescription for ibuprofen plus oxycodone reported higher maximum overnight pain scores. IMPLICATIONS: Participants receiving a prescription for ibuprofen alone had lower maximum overnight pain scores following osmotic dilator placement. Given that opioid prescriptions did not appear to reduce overnight pain, minimizing these prescriptions would avoid opioid exposure for patients undergoing D&E.

Cost-effectiveness of Mifepristone Pretreatment for the Medical Management of Nonviable Early Pregnancy: Secondary Analysis of a Randomized Clinical Trial.

Importance: Early pregnancy loss (EPL) is the most common complication of pregnancy. A multicenter randomized clinical trial compared 2 strategies for medical management and found that mifepristone pretreatment is 25% more effective than the standard of care, misoprostol alone. The cost of mifepristone may be a barrier to implementation of the regimen. Objective: To assess the cost-effectiveness of medical management of EPL with mifepristone pretreatment plus misoprostol vs misoprostol alone in the United States. Design, Setting, and Participants: This preplanned. prospective economic evaluation was performed concurrently with a randomized clinical trial in 3 US sites from May 1, 2014, through April 30, 2017. Participants included 300 women with anembryonic gestation or embryonic or fetal demise. Cost-effectiveness was computed from the health care sector and societal perspectives, with a 30-day time horizon. Data were analyzed from July 1, 2018, to July 3, 2019. Interventions: Mifepristone pretreatment plus misoprostol administration vs misoprostol alone. Main Outcomes and Measures: Costs in 2018 US dollars, effectiveness in quality-adjusted life-years (QALYs), and treatment efficacy. Incremental cost-effectiveness ratios (ICERs) of mifepristone and misoprostol vs misoprostol alone were calculated, and cost-effectiveness acceptability curves were generated. Results: Among the 300 women included in the randomized clinical trial (mean [SD] age, 30.4 [6.2] years), mean costs were similar for groups receiving mifepristone pretreatment and misoprostol alone from the health care sector perspective ($696.75 [95% CI, $591.88-$801.62] vs $690.88 [95% CI, $562.38-$819.38]; P = .94) and the societal perspective ($3846.30 [95% CI, $2783.01-$4909.58] vs $4845.62 [95% CI, $3186.84-$6504.41]; P = .32). The mifepristone pretreatment group had higher QALYs (0.0820 [95% CI, 0.0815-0.0825] vs 0.0806 [95% CI, 0.0800-0.0812]; P = .001) and a higher completion rate after first treatment (83.8% vs 67.1%; P < .001) than the group receiving misoprostol alone. From the health care sector perspective, mifepristone pretreatment was cost-effective relative to misoprostol alone with an ICER of $4225.43 (95% CI, -$195 053.30 to $367 625.10) per QALY gained. From the societal perspective, mifepristone pretreatment dominated misoprostol alone (95% CI, -$5 111 629 to $1 801 384). The probabilities that mifepristone pretreatment was cost-effective compared with misoprostol alone at a willingness-to-pay of $150 000 per QALY gained from the health care sector and societal perspectives were approximately 90% and 80%, respectively. Conclusions and Relevance: This study found that medical management of EPL with mifepristone pretreatment was cost-effective when compared with misoprostol alone. Trial Registration: ClinicalTrials.gov Identifier: NCT02012491.