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ORIGINAL RESEARCH |
From the Gundersen Lutheran Medical Center, La Crosse, Wisconsin.
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ABSTRACT |
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 ABSTRACT METHODS AND MATERIALSRESULTSDISCUSSIONREFERENCES |
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METHODS: A chart review was performed of 1,240 patients receiving care at an integrated medical center for threatened abortion from 1998–2000. Records from 715 patients with adequate follow-up data were reviewed and outcomes studied. Charges for outpatient and inpatient care were obtained from the data warehouse.
RESULTS: Main findings include that on endovaginal ultrasonography, 44% of the pregnancies were viable, of which 86% continued to the end of the first trimester and that of the 33% of pregnancies that were nonviable, 74% successfully miscarried without intervention. Charges for the care varied significantly, based on outcome and choice of site of care.
CONCLUSION: Endovaginal ultrasonography for the evaluation of early pregnancy bleeding has a significant effect on care decisions and costs.
LEVEL OF EVIDENCE: II-3
The first reports of ultrasonography being used to evaluate early pregnancy bleeding were published in 1980. The ability to evaluate the status of the pregnancy led to widespread adoption of ultrasound technology for the evaluation of first-trimester vaginal bleeding in the subsequent decades. Endovaginal ultrasonography represented a significant enhancement of this technology.
When ultrasonography reveals viability, care providers can offer reassurance, even though there are no proven therapeutic options for threatened abortion; alternatively, when ultrasonography reveals nonviability, the management choices can be discussed. Choosing between elective curettage or expectant management became possible with the introduction of ultrasonography. Recently, the option of medical management with misoprostol has been introduced, but has yet to reach a high frequency of use.
Ultrasonography has altered clinical practice, but published articles on the outcomes of these pregnancies rarely include a broad spectrum of patients with first-trimester bleeding and all followed up to a meaningful clinical outcome. This article reports the analysis of outcomes (to the end of the first trimester) associated with bleeding and the influence ultrasound-acquired information has on management.
The costs of care for various strategies of management have seldom been explored. It was our intent to compare the charges generated for the different management options.
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METHODS AND MATERIALS |
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ABSTRACTMETHODS AND MATERIALSRESULTSDISCUSSIONREFERENCES |
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This analysis does not include patients who presented for ultrasonography for other indications, such as pain without vaginal bleeding. Patients with ectopic pregnancies who presented with vaginal bleeding as a first indication for the ultrasonography were included, but this study does not analyze outcomes for all ectopic pregnancies. Patients with no intrauterine gestational sac on original ultrasonography (pregnancy of undetermined location) were included.
The billings databases for Gundersen Clinic and Lutheran Hospital were accessed for all care provided during a 3-month period of time after the initial ultrasonography for each patient. Over 9,000 charges were posted for the 715 patients. Each charge was screened by clinical data management personnel and the primary author to ensure that the charges related to the threatened abortion. Charges for patients with ongoing pregnancies were limited to those specifically related to the threatened abortion. Outpatient pharmacy charges were not available and were not considered. Upon completion of the analysis, mean and median charges for each outcome group were calculated. Statistical analysis was performed using SAS software (SAS Institute Inc., Cary, NC). The Kruskal-Wallis test and the Wilcoxon rank-sum test were used to test for differences in the charges due to the departure from normality present in the charge data. When multiple comparisons were done, the Bonferroni correction was applied to the Wilcoxon rank-sum test. For these comparisons, scheduled curettages were grouped together under each decision arm, because the choice of using the operating room or office depends on many factors, including physician and patient preferences, clinical observations, and operating room availability.
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RESULTS |
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ABSTRACTMETHODS AND MATERIALSRESULTSDISCUSSIONREFERENCES |
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Of 314 patients with a finding of viable pregnancy at initial ultrasonography, a significant majority (86%) continued viability to the end of the first trimester, whereas 14% eventually miscarried. Spontaneous abortions occurred in 36% of these lost pregnancies, 11% required emergency curettages, and 52% underwent a scheduled curettage after repeat ultrasonographies demonstrated nonviability.
Of the 236 patients with findings of nonviability at first ultrasonography, 59% underwent a scheduled curettage. Of the 41% that chose, or agreed to, expectant management, 74% experienced spontaneous miscarriage, 10% required emergency curettage, and 16% later decided to undergo scheduled curettage.
Of the 96 patients who opted for expectant management, 70% miscarried within the first week, although some patients did not complete the miscarriage until beyond 1 month. The risk of requiring an emergency curettage did not increase over the follow-up interval. Sixteen percent abandoned expectant management, most within 1 week of ultrasonography.
For the group with no intrauterine gestational sac on initial ultrasonography, the outcomes were ectopic pregnancy 17%, spontaneous complete abortion 80%, and viable pregnancy 2%. All of these patients underwent follow-up quantitative hCG testing and repeat ultrasonographies as indicated. Overall, 38% (273/715) of all pregnancies evaluated for first-trimester bleeding continued successfully through the first trimester.
Complications were rare in the studied patients. No transfusions were performed. Only 1 patient was identified as experiencing postabortal endometritis for which hospitalization was not required. No cases of uterine injury related to suction curettages performed were identified.
Suction curettages can be performed in 2 settings: the operating room or the clinic. The flow chart (Fig. 1) demonstrates differences in the rates by setting. Because infections and excessive bleeding were rare occurrences, comparison of outcomes by location and provider could not be performed.
For the 715 patients, greater than $1.25 million in charges was generated. Table 2 lists number, mean, standard deviations, and median costs to the end of the first trimester for each of the outcomes. Median charges based on each of the outcomes and/or strategies of care are also exhibited in Figure 1. Overall median charge per patient for the entire population was $591. The median charge for patients with nonviable pregnancy was $1,762.
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A comparison of charges by outcome of the first ultrasound findings confirmed a significant difference between viable pregnancy, nonviable pregnancy, no intrauterine pregnancy, and ectopic pregnancy using the Kruskal-Wallis test (P < .001) (Fig. 1). The lowest total charge was for women with a viable pregnancy, and the highest for those women with nonviable pregnancy or ectopic pregnancy. Other differences in charges by procedure or management within outcomes are denoted in the figure. Total charges for emergency curettage were highest among women whose viable pregnancy miscarried, but there was no difference in total charges for women with nonviable pregnancies and expectant management who underwent emergency or scheduled curettage.
Given the ultrasound finding of nonviable pregnancy, the choice of expectant management or scheduled curettage results in a statistically significant difference in charges ($652 and $1,966, respectively) (P < .001). A pregnancy found viable at the initial ultrasonography that later miscarries has statistically significant differences in charges between spontaneous abortion and emergency curettage (P = .001) and between spontaneous abortion and scheduled curettage (P = .010). The nonviable pregnancy group in which expectant management was used has similar results to scheduled curettage.
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DISCUSSION |
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ABSTRACTMETHODS AND MATERIALSRESULTSDISCUSSIONREFERENCES |
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Ultrasonography has significantly altered the management of nonviable pregnancies. After ultrasonography became available, standard recommendations changed, because it was thought that the risk of infection and excess bleeding increased with waiting.1,18 There is little evidence to support this advice. Beginning with Nielsen and Hahlin in 1995, a number of authors have advocated for expectant management of some inevitable abortions.8,9,19–22 Hurd et al8 and Luise et al9 both demonstrated rates of successful miscarriage of 70% with expectant management, whereas Jurkovic et al10 reported only 25% successful spontaneous abortion. In our population of patients who were managed expectantly, approximately 1 in 8 underwent an emergency curettage.
The expectant approach chosen, or agreed to, by 41% of the patients with nonviable pregnancies proved successful 74% of the time. Hurd et al8 demonstrated that sac size less than 1 cm was the most significant variable to predict successful avoidance of curettage or complications. Sac size was not routinely measured in our ultrasound unit, so we were unable to determine the effect of these measures on success of expectant management.
The time from diagnosis to miscarriage can be unpredictable and quite long in a small minority of patients. However, in this study, 70% of those being followed up expectantly were resolved within a week. Sixteen percent abandoned the expectant management route, usually within this interval. The medical management of missed abortion with misoprostol has been introduced with successful emptying of the uterus in 48 hours in up to 80% of women.23 None of the pregnancies in this study were managed with misoprostol. This method will also have significant implications on management of missed abortion and should be studied further before broad implementation can be expected to occur.
The location of performance of elective termination of missed abortion has not been extensively studied. Several studies report minimal complications with management in the emergency room or on the labor ward.24,25 In our study, 62% of the scheduled curettages were performed in the clinic setting and 38% in the operating room, with no differences in outcomes, but significant differences in charges. If patient safety can be assured and appropriate analgesic options provided, the clinic setting should be the preferred site. It is obvious from this analysis that the costs are significantly different.
The literature on ultrasound diagnosis of ectopic pregnancy is significant in volume and scientific content and will not be reiterated. Several articles have examined the "pregnancy of undetermined location" primarily from the prospective of whether the spontaneous abortion is complete and whether a dilation and curettage can be avoided. Although the rate of completed spontaneous abortion is high, the significant number of "silent ectopics" in this population and the small, but important, rate of very early viable pregnancies suggests that careful follow-up with quantitative hCGs and repeat ultrasonography is necessary.
The cost of care associated with early pregnancy bleeding is significantly altered by the variation in management that results from ultrasound-generated information. Although no patients received care without ultrasonography, cost projections can be devised for this option and a number of other options, including medical management. Further study in this area will need to occur.
Psychological benefits are not compared in this study. Several studies have been done with limited differences in outcomes.29,30 Personal choice is very highly valued. Other analyses based on patient preference and psychological outcomes should be considered in the future.
In discussions about the high cost of care, a procedure that costs several hundred dollars would not seem to have a significant effect on the national costs of healthcare. From this analysis, it is apparent that the alteration in clinical management caused by the procedure leads to significant charge generation; it is not the cost of the ultrasonography, it is the cost of everything we do after the ultrasonography.
Limitations of this study include the necessary retrospective view of these data. The original volume of 1,240 patients was reduced to 715 due to referral specifically for just the ultrasonography, incomplete documentation, or elective termination, and there is no way of determining whether those patients would have had the same outcomes. The International Classification of Diseases, 9th Revision codes identified in a data warehouse may not have captured all patients or all charges. An inability to capture reimbursements instead of charges further weakens this analysis. The ability to better understand the decision-making between expectant and surgical management of missed abortion and location of curettage (operating room or office) would be further enhanced by a study with a prospective approach.
In summary, transvaginal ultrasonography changed the management of threatened abortion by providing patients and physicians with information about the status of the pregnancy. No significant differences in medical outcomes could be demonstrated based on the management method chosen. However, significant differences in charges resulted. Further study will be necessary to understand patient and physician decision-making processes.
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Footnotes |
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Reprints are not available. Address correspondence to: Charles Schauberger, MD, 1900 South Avenue, La Crosse, WI 54601; e-mail: cwschaub{at}gundluth.org.
Received July 31, 2004. Received in revised form September 7, 2004. Accepted September 16, 2004.
doi:10.1097/01.AOG.0000151105.53557.27
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REFERENCES |
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