Mifepristone Combination Therapy Compared With Misoprostol Monotherapy for the Management of Miscarriage: A Cost-Effectiveness Analysis.

OBJECTIVE: To assess whether mifepristone pretreatment adversely affects the cost of medical management of miscarriage. METHODS: Decision tree analyses were constructed, and Monte Carlo simulations were run comparing costs of combination therapy (mifepristone and misoprostol) with monotherapy (misoprostol alone) for medical management of miscarriage in multiple scenarios weighing clinical practice, patient income, and surgical evacuation modalities for failed medical management. Rates of completed medical evacuation for each were obtained from a recent randomized controlled trial. RESULTS: In every scenario, combination therapy offered a significant cost advantage over monotherapy. Using a Monte Carlo analysis, cost differences favoring combination therapy ranged from 6.3% to 19.5% in patients making federal minimum wage. The cost savings associated with combination therapy were greatest in scenarios using a staged approach to misoprostol administration and in scenarios using in-operating room dilation and curettage as the only modality for uterine evacuation, a savings of $190.20 (99% CI 189.35-191.07) and $217.85 (99% CI 217.19-218.50) per patient in a low-income wage group, respectively. A smaller difference was seen in scenarios using in-office manual vacuum aspiration to complete medical management failures. As patients' wages increased, the difference in cost between combination therapy and monotherapy increased. CONCLUSION: Mifepristone combined with misoprostol is, overall, more cost effective than monotherapy, and therefore cost should not be a deterrent to its adoption in the management of miscarriage.

Decreasing Diagnostic Hysteroscopy Performed in the Operating Room: A Quality Improvement Initiative.

OBJECTIVES: At our institution, diagnostic hysteroscopy (DH), often combined with uterine curettage, commonly has been performed in the main OR with the patient under general anaesthesia. Our objective was to create targeted interventions aimed at decreasing the number of DHs performed in the OR by 75% over one year. METHODS: This quality improvement initiative had a quasi-experimental (time-series) design. To obtain baseline numbers of DHs performed each month, we conducted a retrospective chart audit at a university teaching hospital. We implemented the following three groups of interventions: (1) staff education and case review, (2) accessible sonohysterography, and (3) an operative hysteroscopy education program. Procedures were tracked prospectively over a 12-month intervention period and an additional 12-month maintenance period. RESULTS: One hundred eleven DHs were performed at baseline. During the intervention period, 33 DHs were performed, a 70% reduction from baseline. This resulted in related savings of $126 984 and 12.5 surgical days. In the final quarter of the intervention period, there was an 81% reduction in the number of DHs with adequate preoperative evaluation compared with baseline. Twenty DHs were performed in the maintenance period, an 82% reduction from baseline. The absolute number of complications from DH remained constant during the study period. CONCLUSION: Carefully planned and targeted interventions to change the culture at our institution decreased the number of DHs performed in the main OR. These initiatives improved patient care, saved costs, and improved OR utilization. Long-term follow-up showed maintenance of the improvements in the year subsequent to the interventions.

Beyond usual care: the economic consequences of expanding treatment options in early pregnancy loss.

OBJECTIVE: The objective of this study was to estimate the economic consequences of expanding options for early pregnancy loss (EPL) treatment beyond expectant management and operating room surgical evacuation (usual care). STUDY DESIGN: We constructed a decision model using a hypothetical cohort of women undergoing EPL management within a 30 day horizon. Treatment options under the usual care arm include expectant management and surgical uterine evacuation in an operating room (OR). Treatment options under the expanded care arm included all evidence-based safe and effective treatment options for EPL: expectant management, misoprostol treatment, surgical uterine evacuation in an office setting, and surgical uterine evacuation in an OR. Probabilities of entering various treatment pathways were based on previously published observational studies. RESULTS: The cost per case was US $241.29 lower for women undergoing treatment in the expanded care model as compared with the usual care model (US $1033.29 per case vs US $1274.58 per case, expanded care and usual care, respectively). The model was the most sensitive to the failure rate of the expectant management arm, the cost of the OR surgical procedure, the proportion of women undergoing an OR surgical procedure under usual care, and the additional cost per patient associated with implementing and using the expanded care model. CONCLUSION: This study demonstrates that expanding women's treatment options for EPL beyond what is typically available can result in lower direct medical expenditures.

Risks and benefits of hysteroscopy and endometrial sampling as a standard procedure for assessing serendipitous findings of endometrial thickening in postmenopausal women.

A retrospective study was undertaken of 35 asymptomatic postmenopausal women undergoing hysteroscopy, dilatation and curettage (H D&C) for an incidental finding of thickened endometrium to assess the rate of significant pathological findings, cost per finding and complication rate of any procedures performed. This study found one case of endometrial adenocarcinoma (1/35; 3%) at an estimated cost per significant finding of $507,116 with an estimated 11.6 complication events per finding.

Surgical versus expectant management in women with an incomplete evacuation of the uterus after treatment with misoprostol for miscarriage: the MisoREST trial.

BACKGROUND: Medical treatment with misoprostol is a non-invasive and inexpensive treatment option in first trimester miscarriage. However, about 30% of women treated with misoprostol have incomplete evacuation of the uterus. Despite being relatively asymptomatic in most cases, this finding often leads to additional surgical treatment (curettage). A comparison of effectiveness and cost-effectiveness of surgical management versus expectant management is lacking in women with incomplete miscarriage after misoprostol. METHODS/DESIGN: The proposed study is a multicentre randomized controlled trial that assesses the costs and effects of curettage versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Eligible women will be randomized, after informed consent, within 24 hours after identification of incomplete evacuation of the uterus by ultrasound scanning. Women are randomly allocated to surgical or expectant management. Curettage is performed within three days after randomization.Primary outcome is the sonographic finding of an empty uterus (maximal diameter of any contents of the uterine cavity < 10 millimeters) six weeks after study entry. Secondary outcomes are patients' quality of life, surgical outcome parameters, the type and number of re-interventions during the first three months and pregnancy rates and outcome 12 months after study entry. DISCUSSION: This trial will provide evidence for the (cost) effectiveness of surgical versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage. TRIAL REGISTRATION: Dutch Trial Register: NTR3110.

Surgical abortion prior to 7 weeks of gestation.

The following guidelines reflect a collation of the evaluable medical literature about surgical abortion prior to 7 weeks of gestation. Early surgical abortion carries lower risks of morbidity and mortality than procedures performed later in gestation. Surgical abortion is safe, practicable and successful as early as 3 weeks from the start of last menses (no gestational sac visible on vaginal ultrasound) provided that (a) routine sensitive pregnancy testing verifies pregnancy, (b) the tissue aspirate is immediately examined for the presence of a gestational sac plus villi and (c) a protocol to identify ectopic pregnancy expeditiously--including calculation of readily obtained serial serum quantitative human chorionic gonadotropin titers when clinically appropriate--is in place and strictly adhered to. Manual and electric vacuum aspiration methods for early abortion demonstrate comparable efficacy, safety and acceptability. Current data are inadequate to determine if any of the following techniques substantially improve procedure success or safety: use of rigid versus flexible cannulae, light metallic curettage following uterine aspiration, uterine sounding or routine use of intraoperative ultrasound.

Costs associated with management of cervical human papillomavirus-related conditions.

BACKGROUND: Oncogenic types of human papillomavirus (HPV) have been linked to 99.7% of cervical cancer cases worldwide. METHODS: This retrospective claims-based analysis was conducted to assess patterns of use and costs associated with diagnostic and treatment procedures for disease attributed to HPV performed before the introduction of HPV vaccination (January 1, 2001-May 31, 2006). Percentages of commercially insured health plan enrollees who underwent each procedure of interest were calculated for each year. Annual costs (combined patient and health plan-paid amounts) were calculated from qualifying medical claims. Descriptive statistics were used to assess trends in procedure rates and costs. RESULTS: Data for approximately 14.2 million enrollees were obtained. Hysterectomy was the most commonly administered treatment. With the exception of colposcopy with LEEP, all other treatment procedures experienced a decline in rate of use. The most frequently performed diagnostic procedure was colposcopy with endocervical curettage (ECC). With the exception of ECC, rates of diagnostic procedures reached a peak among 20- to 24-year-olds, and followed a downward trend across older groups. Hysterectomy was the most expensive treatment (median $7,383; mean $8,384) per procedure in 2006. CONCLUSION: Results reveal high rates of use and high-associated costs of diagnostic procedures and treatments related to disease attributed to HPV. IMPACT: The data presented may be useful in cost-effectiveness analyses and to guide decision makers evaluating how best to optimize prevention strategies.

A comparative study of cost of care and duration of management for first-trimester abortion with manual vacuum aspiration (MVA) and sharp curettage.

OBJECTIVE: This study compared the hospital charges, duration of in-hospital procedures, clinical course and complications between manual vacuum aspiration (MVA) and sharp curettage. MATERIALS AND METHODS: A prospective observational study was conducted during the May 2007-April 2008 period in Songklanagarind Hospital, Thailand. Forty cases of pregnancy ≤9 weeks of gestation, with conditions of an incomplete abortion, a blighted ovum or missed abortion were treated with either MVA or sharp curettage. Both groups were compared in terms of demographic and obstetric data, hospitalization cost, clinical course and complications. RESULTS: The obstetric data of both groups showed that the median parity was two, with a median gestation age of 8 weeks. The median total hospital expenditure was 54.67 USD for patients using the MVA technique and 153.97 USD for the sharp curettage group (p < 0.01). The median duration of in-hospital care in the MVA group was significantly less than that of the sharp curettage group, 4 versus 20 h, respectively (p < 0.01). 90 % of patients in the MVA group had only one visit compared with 72.5 % in the sharp curettage group (p = 0.04). No complications needing further curettage or treatment in either group were noted. CONCLUSION: The use of MVA in the management of a first-trimester abortion is practical, safe, cheap and time-saving.

Cost-effectiveness analysis of unsafe abortion and alternative first-trimester pregnancy termination strategies in Nigeria and Ghana.

To explore the policy implications of increasing access to safe abortion in Nigeria and Ghana, we developed a computer-based decision analytic model which simulates induced abortion and its potential complications in a cohort of women, and comparatively assessed the cost-effectiveness of unsafe abortion and three first-trimester abortion modalities: hospital-based dilatation and curettage, hospital- and clinic-based manual vacuum aspiration (MVA), and medical abortion using misoprostol (MA). Assuming all modalities are equally available, clinic-based MVA is the most cost-effective option in Nigeria. If clinic-based MVA is not available, MA is the next best strategy. Conversely, in Ghana, MA is the most cost-effective strategy, followed by clinic-based MVA if MA is not available. From a real world policy perspective, increasing access to safe abortion in favor over unsafe abortion is the single most important factor in saving lives and societal costs, and is more influential than the actual choice of safe abortion modality.

Cost-effectiveness analysis of alternative first-trimester pregnancy termination strategies in Mexico City.

OBJECTIVE: To assess the comparative health and economic outcomes associated with three alternative first-trimester abortion techniques in Mexico City and to examine the policy implications of increasing access to safe abortion modalities within a restrictive setting. DESIGN: Cost-effectiveness analysis. SETTING: Mexico City. POPULATION: Reproductive-aged women with unintended pregnancy seeking first-trimester abortion. METHODS: Synthesising the best available data, a computer-based model simulates induced abortion and its potential complications and is used to assess the cost-effectiveness of alternative safe modalities for first-trimester pregnancy termination: (1) hospital-based dilatation and curettage (D&C), (2) hospital-based manual vacuum aspiration (MVA), (3) clinic-based MVA and (4) medical abortion using vaginal misoprostol. MAIN OUTCOME MEASURES: Number of complications, lifetime costs, life expectancy, quality-adjusted life expectancy. RESULTS: In comparison to the magnitude of health gains associated with all safe abortion modalities, the relative differences between strategies were more pronounced in terms of their economic costs. Assuming all options were equally available, clinic-based MVA was the least costly and most effective. Medical abortion with misoprostol provided comparable benefits to D&C, but cost substantially less. Enhanced access to safe abortion was always more influential than shifting between safe abortion modalities. CONCLUSIONS: This study demonstrates that the provision of safe abortion is cost-effective and will result in reduced complications, decreased mortality and substantial cost savings compared with unsafe abortion. In Mexico City, shifting from a practice of hospital-based D&C to clinic-based MVA and enhancing access to medical abortion will have the best chance to minimise abortion-related morbidity and mortality.

Patient preferences, satisfaction, and resource use in office evacuation of early pregnancy failure.

OBJECTIVE: To examine patient treatment preferences and satisfaction with an office-based procedure for early pregnancy failure and to compare resource use and cost between office and operating room management of early pregnancy failure. METHODS: This study was a prospective observational study of 165 women presenting for surgical management of early pregnancy failure. Participants completed a preoperative questionnaire addressing treatment preferences and expectations and a postoperative questionnaire measuring level of pain experienced and satisfaction with care. Resource use was determined by measuring the time patients spent at the health care facility and the actual procedure time. Cost was estimated using an institutional database. RESULTS: One hundred fifteen women from the office and 50 from the operating room were enrolled. Patients selecting outpatient management scored "privacy," "avoiding going to sleep," and "previous experience" higher than the operating room group (P < .05). Patients who perceived that their physicians preferred one procedure over the other were more likely to select that procedure (P < .001). Satisfaction was high in both groups, and underestimating the procedure's discomfort was negatively associated with satisfaction (P < .002). Costs were greater than two-fold higher in the operating room group compared with the office group (P < .01). Complications were uncommon, but hemorrhage-related complications were four times more common in the operating room group than in the office group (P < .01). CONCLUSION: Office-based surgical management of early pregnancy failure is an acceptable option for many women and offers substantial resource and cost savings. LEVEL OF EVIDENCE: II-2.

Cost-effectiveness of dilation and evacuation versus the induction of labor for second-trimester pregnancy termination.

OBJECTIVE: The purpose of this study was to compare the cost-effectiveness of dilation and evacuation versus misoprostol induction of labor for second-trimester termination. STUDY DESIGN: Using decision analysis, we compared the cost-effectiveness of dilation and evacuation and misoprostol induction of labor for second-trimester termination. Complications for dilation and evacuation and induction of labor included repeat dilation and curettage, cervical laceration repair, hospital admission, laparotomy, hysterectomy, and maternal death. Induction of labor complications also included failed induction of labor. The primary outcome was cost per quality-adjusted life year. Sensitivity analyses were performed for all relevant variables. RESULTS: Dilation and evacuation was less costly and more effective than misoprostol induction of labor for second-trimester termination with baseline estimates. In 1-way sensitivity analysis, the model was robust to all variation in probabilities and costs. In Monte Carlo simulation with 1000 trials and a cost-effectiveness threshold of $50,000/quality-adjusted life year, dilation and evacuation was the preferred approach in 97.9% of trials. CONCLUSION: Dilation and evacuation is less expensive and more effective than misoprostol induction of labor for second-trimester termination.

Management strategies for abnormal early pregnancy: a cost-effectiveness analysis.

OBJECTIVE: To assess the potential effectiveness and costs of 4 commonly used strategies to manage abnormal early pregnancies (AEPs). STUDY DESIGN: A decision analysis model was constructed to compare 4 strategies to manage AEPs: (1) observation, (2) medical management, (3) manual vacuum aspiration (MVA), and (4) dilation and curettage (D&C). RESULTS: MVA was the most cost-effective strategy, at dollar 793 per cure, for a total cost of dollar 377 million per 500,000 women and a cure rate of 95%. D&C was more effective than MVA, with a cure rate of 99%, but was more expensive (dollar 2,333 per cure, for a total cost of dollar 1.2 billion). D&C cured 20,000 more patients than MVA; however, at a substantial cost of dollar 38,925 per additional cure. With other estimates at baseline, MVA remained more cost-effective than D&C until the efficacy of MVA was < 82% or the cost of D&C was < dollar 240. CONCLUSION: MVA is the most cost-effective strategy for managing AEP and would be appropriate in settings in which resources are limited. D&C remains a reasonable strategy; however, one must spend dollar 38,925 per additional cure. In the United States, MVA would save dollar 779 million per year relative to D&C.

Expectant, medical or surgical treatment for spontaneous abortion in first trimester of pregnancy: a cost analysis.

BACKGROUND: Misoprostol and expectant care have been shown to be acceptable alternatives to routine surgical evacuation for treatment of spontaneous abortion in the first trimester of pregnancy. The objective of this study was to analyse the cost of expectant care, misoprostol therapy and surgical evacuation. METHODS: A decision tree was designed to simulate the clinical outcome and health care resource utilization of surgical evacuation, misoprostol and expectant care for patients presenting with uncomplicated spontaneous abortion in the first trimester of pregnancy. Clinical inputs were estimated from literature and the cost analysis was conducted from the perspective of a public health care provider in Hong Kong. RESULTS: The base-case analysis showed that the misoprostol group (1000 US dollars per patient) was the least costly alternative, followed by the expectant care (1172 US dollars per patient) and surgical evacuation (2007 US dollars per patient). Rates of complete abortion using misoprostol and expectant care were identified as influential factors. Monte Carlo simulation (10000 cohorts) showed that the misoprostol and the expectant care groups were less costly than the surgical evacuation group 100 and 88% of the time. The misoprostol group was less costly than the expectant group 100% of the time. CONCLUSIONS: Misoprostol therapy appears to be the least costly approach for treatment of uncomplicated spontaneous abortion.

Cost-effectiveness of presumptively medically treating women at risk for ectopic pregnancy compared with first performing a dilatation and curettage.

OBJECTIVE: To compare the cost and complication rate of two alternative strategies for the diagnosis and medical management of ectopic pregnancy when ultrasound is nondiagnostic. DESIGN: A decision tree was constructed to compare [1] dilatation and curettage (D&C) followed by treatment of all ectopic pregnancies with methotrexate versus [2] empiric treatment of all patients with possible ectopic pregnancies with methotrexate without D&C. SETTING: University setting. PATIENT(S): Ten thousand hypothetical women with nonviable pregnancies and a known incidence of ectopic pregnancy were entered into a computer model. MAIN OUTCOME MEASURE(S): The two approaches were compared with respect to the number of missed ectopic pregnancies, complications, procedures performed, admissions to the hospital, and cost. RESULT(S): The D&C group had 1% more failed managements of ectopic pregnancies and 13.4% fewer patients with a miscarriage undergo a second treatment for resolution. The D&C group had 13.7% fewer complications including 6.3% fewer hospitalizations. D&C costs $173 to $223 more than empiric use of methotrexate per patient. CONCLUSION(S): Empirically treating women at risk for ectopic pregnancy with methotrexate does not reduce complications or save money. In the absence of such savings, the desire to make an accurate and definitive diagnosis, allowing objective prognosis on future fertility and risk of repeat ectopic pregnancy, supports the need to distinguish a miscarriage from ectopic pregnancy before treatment with methotrexate.

Economic evaluation of misoprostol in the treatment of early pregnancy failure compared to curettage after an expectant management.

BACKGROUND: The increased pressure on health care expenses implies that physicians should consider economic aspects as part of the clinical decision-making process. Direct and indirect costs of a strategy starting with misoprostol in treatment of early pregnancy failure as compared to curettage is therefore performed. METHODS: We performed a cost-minimization analysis alongside a multicentre randomized trial. Clinical data and data on the use of medical resources were obtained from a randomized trial comparing misoprostol and curettage, which had shown that misoprostol reduced the need for curettage in 53%. In a sensitivity analysis the percentage of women who needed curettage after misoprostol varied between 25 and 90%. RESULTS: Direct costs per case were significantly lower in the misoprostol group (mean 433) than in the curettage group (mean 683) (mean difference 250, 95% CI 184 to 316, P < 0.001). These significant differences existed under a wide range of alternative assumptions about unit costs. The differences in direct cost in favour of misoprostol were large for women who had complete evacuation after initial misoprostol treatment as compared to those who needed additional curettage after failed misoprostol. Mean indirect costs were equal for both groups (misoprostol mean 486; curettage mean 428; mean difference 60, 95% CI -61 to 179, P = 0.51). The mean total costs for a strategy starting with misoprostol was 915 versus 1107 for curettage, with a mean difference between both groups of 192 (95% CI 33 to 351, P = 0.04). An increase of the complete evacuation rates for initial misoprostol therapy to 90% in the sensitivity analysis increased the cost difference between misoprostol and curettage to 550. CONCLUSION: The use of misoprostol for early pregnancy failure after failed expectant management is less costly than curettage.

Dilatation and curettage: praxeology.

OBJECTIVES: To determine variations in the rate of inpatient and outpatient dilatation and curettage (D&C), for the treatment of early pregnancy loss, and for the diagnosis of abnormal uterine bleeding, in 17 health regions across a Canadian province. DESIGN: Frequency of D&C was examined in a cohort of 1.36 million women in Alberta. All inpatient and outpatient episodes in which dilatation and curettage was used for management of early pregnancy loss and for diagnosis or treatment of abnormal uterine bleeding were included. Variations in frequency among the 17 health regions were examined. RESULTS: Rates of D&Cs performed following miscarriage or pregnancy showed a 4-fold variation among the 17 regions, between women aged 20 to 34 years and 35 to 49 years. Consistency within the regions, when comparing both groups of women, was significant (r2 = 0.5542, p = 0.00006). The rates for D&C for abnormal uterine bleeding showed up to 5-fold variation among the 17 regions between women aged 20 to 34 years, 35 to 49 years, and 50 years or more. The Pearson correlation coefficient for association of rates for procedure codes 69.02 and 69.09 across the regions was 0.62 (p < 0.01). Percentages of procedures performed as inpatients ranged between 33.3% and 83.3% for procedure code 69.02, and between 5% and 17% for procedure code 69.09. The Pearson correlation coefficient for inpatient surgery frequency was 0.5913 (p < 0.02) across the regions. Substantial variations in the frequency of D&C were observed among health regions, and between urban and rural dwellers. CONCLUSIONS: Substantial variations in D&C utilization were found in Alberta, rendering the need for a more detailed analysis. The extent of variation among regions is difficult to explain on grounds other than physician preference. High variation in rates of procedure codes 69.02 and 69.09 performed on an outpatient basis suggests that lower rates of inpatients could be achieved in many regions for both procedures. The higher estimated cost of D&C procedures compared to office biopsies in Alberta is a good incentive to re-examine the role of and need for performing D&Cs.

Endometrial brush biopsy for the diagnosis of endometrial cancer.

OBJECTIVE: To evaluate a new technique for processing endometrial cytology for the diagnosis and exclusion of endometrial cancer. STUDY DESIGN: All women at risk for endometrial cancer with clinical indications for endometrial biopsy were evaluated by endometrial brush biopsy (Tao Brush, Cook OB-GYN, Bloomington, Indiana) and Pipelle (Cooper Surgical, Shelton, Connecticut) endometrial biopsies during one office visit. Patients were followed longitudinally for the development of endometrial cancer or until undergoing dilatation and curettage or hysterectomy. All comparisons were analyzed using the chi 2 or t test. RESULTS: One hundred one women (mean age, 58; range, 35-86) had endometrial biopsies performed. Median follow-up was > 21 months (range, 3-29). Twenty-two had cancer or atypia, while the remaining had benign diagnoses. When correlated with the final diagnosis, the Tao Brush had 95.5% sensitivity and the Pipelle, 86% sensitivity. Both devices had 100% specificity, positive predictive value of 100% and negative predictive value of 98%. When the results of the two biopsy devices are considered together, the positive and negative predictive value for detecting or excluding endometrial cancer was 100%. Based on 1998 Medicare reimbursements, a simultaneous second office biopsy using the Tao brush could save approximately $67 per case as compared to a sonohistogram and much more when compared to dilatation and curettage. CONCLUSION: Endometrial cancer can be reliably detected and excluded using these two distinct office biopsy devices simultaneously during one office visit. In patients with an indication for endometrial biopsy, no further diagnostic test may be necessary to exclude or diagnose endometrial cancer or atypia.

Early pregnancy failure--current management concepts.

Approximately one in four women will experience a miscarriage during her lifetime. For more than 50 years, the standard management of early pregnancy failure has been a dilatation and curettage (D & C). Typically, the procedure is performed in an operating room, which significantly increases cost. There is little objective information in the modem literature to prove that a D & C for all patients will lower morbidity or improve emotional well being. Treatment options include expectant management, D & C in an outpatient setting, and medical management with misoprostol (not approved by the U.S. Food and Drug Administration for treatment of early pregnancy failure). The medical literature supports that expectant management may result in more complications, including the need for "emergent" curettage, if clinicians do not understand the true normal course of expectant management. In general, women prefer some form of active management. Dilatation and curettage can be performed safely in the office or other outpatient setting using manual vacuum aspiration. Vaginal misoprostol will cause expulsion in 80% to 90% of women up to 13 weeks' uterine size or gestation, including patients who have a gestational sac present. However, these data come from only three trials involving a total of 42 subjects treated with vaginal misoprostol, and another study of 42 women who received vaginal misoprostol for "missed abortion" before a scheduled D & C. There is a significant lack of information from large-scale studies about when treatment is necessary and the relative efficacy, rates of side effects, and acceptability of these various treatment options for early pregnancy failure.