This study demonstrates that overall, medical therapy is a cost-effective treatment of early pregnancy loss. However, there are situations when surgical management is both more effective and less costly than medical management. Surgery can become more efficacious and less costly if a) surgical treatment is done in an outpatient setting (without general anesthesia), b) the probability of medically treated women needing extra visits is high or c) the cost of outpatient visit is high and success of medical management is low. Conversely, medical management becomes both less costly and more efficacious in the case of incomplete or inevitable abortions as well as when a patient’s desire to avoid surgery is high.
Evaluating the type of surgical procedure, manual vacuum aspiration and electric vacuum aspiration, separately shows a distinction in terms of cost which then translates into its cost efficacy. MVA, given that it is an outpatient procedure which does not require an operating room, has clear savings in terms of cost and time over EVA, with no appreciable change in efficacy (5
). Office-based surgical management of early pregnancy failure not only offers cost savings over operating room management, but with similar patient satisfaction without increased complication rates (7
). Data from our own randomized trial indicate that although pain severity scores were better in the EVA group, the MVA group had better physical and emotional role functioning scores and fewer patients undergoing MVA missed work or required help at home (8
). In another model with estimated outcomes from the literature, MVA was also found to be a more cost-effective strategy than medical management (9
). Our present study confirms the conclusions that MVA is more cost-effective than medical management, but has the advantages of using estimated patient cost and efficacy from a randomized trial in the United States. Currently, MVA is not universally available in outpatient settings treating women with early pregnancy failure, but this study provides further evidence that it would be a manner of increasing efficacy of miscarriage treatment over medical management without needing to sacrifice time and money associated with sending a patient to the operating room.
We also found that the type of miscarriage affected the incremental cost-efficacy ratio. Stratifying the type of miscarriage into embryonic or fetal death, anembryonic gestation and incomplete or inevitable abortion, medical therapy in the incomplete or inevitable abortion group is both less costly and more effective with a dominated ICER. The failure rates for the three miscarriage types in the study were 19% for anembryonic gestation, 12% for embryonic or fetal demise and 7% for incomplete or inevitable abortion. Pooled data of medical versus surgical treatment of incomplete miscarriage shows that surgical management had 1.5 times the chance of success over medical management (10
). However, the regimens as well as efficacy of medical management for treating incomplete abortion in these studies varied greatly, from 13% success with a single dose of 400μg of misoprostol orally (11
) to 95% success with 200μg of misoprostol four times daily (orally) after 200μg of misoprostol intravaginally for 5 days (12
). Other studies comparing incomplete to missed abortions found lower failure rates for the incomplete abortion group (0–7.1%) than for the missed abortions (13.3–23.1%) with varying misoprostol regimens (13
). The results presented here demonstrate that for treatment of the incomplete or inevitable miscarriage subtype, not only is medical management more efficacious than for the other miscarriage subtypes, but when cost is factored in, medical management becomes both more efficacious and less costly than surgical management. While costs form one intuitions were used in the study, unless the relative cost of procedures and medication are dramatically different at other institutions, these findings should be valid externally.
Women’s preferences and experiences with medical treatment vary, and are difficult to quantitate. However, an individual woman’s choice should be taken into account when there are safe efficacious alternatives. This study supports the notion that if a person’s desire for one intervention is high over another (for instance, medical versus surgery) it can affect an incremental cost-effectiveness ratio. In the current analysis, women would need to prefer surgical management 14% less than medical management for medical therapy to become relatively more efficacious and less costly. Quality of life questionnaires from the current study indicated that although misoprostol treatment was associated with greater pain and lower acceptability of treatment-related symptoms, treatment acceptability and quality of life were similar for both medical and surgical treatment (4
). Other investigation into the acceptability of misoprostol for the treatment of miscarriage suggest that the majority of women would recommend and choose their type of treatment again, but the percentage of women who reported high acceptability of medical who recommend it significantly decreased if the procedure was unsuccessful (16
). One study reported that women preferred misoprostol treatment over surgical evacuation as long as the success rate with medical therapy exceeds 65%, stating the desire to avoid surgery or for a more natural process most commonly (17
Other studies have demonstrated an economic advantage of medical management over the traditional surgical management (19
), but direct comparisons are limited due to varied management strategies, definitions of outcome measures and assignment of cost. The estimates in the analysis in You et al. were based on pooled data from the literature (20
), and those from Petrou et al and Graziosi et al were from a study of women in southern England and the Netherlands, respectively (19
). In the British study, the primary endpoint was complete evacuation, and women with incomplete miscarriage were excluded. The medical therapy was 800μg misoprostol vaginally, repeated in 24 hours if needed, whereas the surgical management consisted of all suction curettages with general anesthesia. (21
) In the Dutch study, the primary effectiveness outcome was cost per gynecologic infection prevented. Women in the surgical arm all received surgical suction curettage with general anesthesia and those in the medical arm were admitted to the hospital (22
). Moreover in this study, treatment varied by miscarriage type; those with incomplete miscarriages were treated with 800μg misoprostol whereas missed abortions were treated with a combination of mifepristone and misoprostol (22
). Our data using a United States based population, confirm some these previous findings while demonstrating that medical management with misoprostol was more cost-effective compared to surgically-based therapy (comprised of manual vacuum aspiration and electric vacuum aspiration) as a whole, but further demonstrate a cost-savings if only MVA is performed. Of note, rare but serious adverse events such as intrauterine adhesions were not factored into this analysis as no such cases were noted in our large clinical trial. This study did not evaluate the cost effectiveness of expectant management.
The strengths of this study include the use of a large, multicenter randomized trial, with data on varying types of miscarriages and both available surgical interventions for treatment of early pregnancy failure. Patients were randomized to vaginal misoprostol or surgical management and thus expectant management or other types of medical management (such as mifepristone or alternative regimens of misoprostol), or the effect of patient choice could not be evaluated in this study. Further, although our utilities studies demonstrate a point at which patient preference would affect the cost-effectiveness ratio, we do not have the data necessary to determine how this utility can be translated back to inform clinical practice. Finally, generalizability of this study is limited to a United States population given the differences in health care systems and cost throughout the world, and even within the United States, MVA is not universally available for use in outpatient settings.
In conclusion, this study demonstrates that although surgery is the more efficacious and more costly treatment of first trimester pregnancy failure, this is not always the case. If surgical treatment is done in an outpatient setting without incurring the additional operation room and anesthesia costs, surgical treatment with manual vacuum aspiration is less costly as well as more efficacious than medical management. Finally, there are certain situations when medical management should be considered over surgical management, such as when a patient desires to avoid surgery or has an incomplete or inevitable abortion.