This page contains the following sections:
"Incomplete Abortion"
Failed Abortion
Uterine Infection
Ectopic Pregnancy
Death
Serious complications are uncommon following both medical and surgical abortion. Complications associated with surgical abortion, such as uterine perforation and adverse reactions to anesthesia, result either directly or indirectly from the need to instrument the uterus. Successful medical abortion avoids these types of complications, as it terminates pregnancy without the need for invasive surgery and anesthesia.
The main complications associated with medical abortion are persistent nonviable gestational sac, persistent bleeding requiring surgical intervention (described collectively as "incomplete abortion" in some medical abortion studies), continuing pregnancy, hemorrhage (discussed in Case Presentation 2), infection, and undiagnosed ectopic pregnancy.
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After reading this section, you should be able to answer the following question:
In clinical trials, which findings have NOT been included in the definition of an "incomplete abortion"? |
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"Incomplete Abortion"
In most medical abortion research trials involving mifepristone/misoprostol, the outcome of "incomplete abortion" included women with a persistent nonviable gestational sac on ultrasonography 2 weeks after administration of mifepristone. Some trials also included cases of prolonged bleeding resulting in suction curettage, a clinical presentation suggestive of failure to expel all pregnancy tissue.
Early protocols mandated surgical evacuation of the uterus when the sonogram
at the 2-week follow-up visit revealed a nonviable pregnancy.3,6,19,20,27,30 However,
research trials using methotrexate/misoprostol indicate that expulsion of the
gestational sac will generally occur eventually - an average of 22 to
29 days after methotrexate administration.10,11,26,31,32
In light of these findings, the most recent U.S. mifepristone studies extended the allowable observation period for a persistent sac to approximately 36 days.4,7,8
A meta-analysis of medical abortion trials by Kahn and colleagues5 reported incomplete abortion rates of 2.9% for mifepristone/misoprostol regimens and 2.4% for methotrexate/misoprostol regimens in women with pregnancies of ≤ 49 days' gestation. For both mifepristone and methotrexate regimens, incomplete abortion rates increased with advancing gestational age. With mifepristone regimens, the use of oral misoprostol resulted in higher rates of incomplete abortion than the use of vaginal misoprostol (6.4% vs. 2.1%, p = .05).
All women should undergo follow-up within 2 weeks after initiation of the medical abortion regimen to confirm whether or not the abortion is complete. Symptoms of persistent or heavy bleeding raise the possibility of incomplete abortion. However, some women with a retained gestational sac will be asymptomatic.
If the history reveals either no bleeding or continued, heavy bleeding, or examination reveals an enlarged uterus, an ultrasound examination is warranted to rule out incomplete abortion or continuing pregnancy. If the patient has a persistent nonviable pregnancy, the ultrasound typically shows a gestational sac without signs of continued development or embryonic cardiac activity.
Management of a persistent gestational sac depends on several factors, including the patient's medical condition and preferences, the provider's experience and judgment, and logistical factors affecting follow-up (e.g., the patient's need for child care and transportation).
Click here to view Figure 3.
Patients who are clinically stable have several options: observation and re-evaluation, repeat misoprostol, or uterine aspiration. Women who opt for simple observation can wait an additional 3 to 4 weeks for the sac to pass. Some patients are reassured to know they will no longer have pregnancy-related symptoms during this waiting period.
In most cases, a repeat ultrasound at the follow-up visit will confirm expulsion of the gestational sac.33 Some researchers have used additional doses of misoprostol,22 although no studies have demonstrated the superiority of this approach over expectant management. Incomplete abortion associated with excessive bleeding or infection is an indication for suction curettage.
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After reading this section, you should be able to answer the following question:
Results of clinical trials using the FDA-approved regimen of mifepristone and oral misoprostol demonstrate what relationship between gestational age and rates of continuing pregnancy? |
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Failed Abortion
"Continuing pregnancy" occurs when the medical abortion regimen fails to terminate the pregnancy. The diagnosis is established when ultrasound reveals a viable pregnancy with embryonic cardiac activity 2 weeks after initiating treatment.
Continuing pregnancy is uncommon in women undergoing medical abortion at ≤ 49 days' gestation. The study by Spitz and colleagues3 using the FDA-approved medical abortion regimen reported rates of continuing pregnancy of 1% for gestations ≤ 49 days, 4% for gestations between 50 and 56 days, and 9% for gestations between 57 and 63 days.
A meta-analysis of medical abortion trials published by Kahn and colleagues5 in 2000 reported comparable continuing pregnancy rates for regimens using mifepristone and misoprostol or methotrexate and misoprostol in women with gestations ≤ 49 days.
In a randomized trial comparing mifepristone followed by oral or vaginal misoprostol in women with pregnancies of ≤ 63 days, El-Refaey and colleagues27 found a significantly higher rate of ongoing pregnancy with the oral regimen (1% vs. 7%, p = .01). This finding is supported by U.S. trials showing continuing pregnancy rates of < 1% in women using mifepristone and vaginal misoprostol up to 63 days' gestation.7
When continuing pregnancy occurs, women are likely to report little to no bleeding after taking abortifacients. Commonly, pregnancy symptoms are still present. Physical examination will not reveal evidence of uterine involution. An ultrasound finding of a developing embryo with cardiac activity at the 2-week follow-up visit establishes the diagnosis. If the gestation is less than 47 days (embryonic pole less than 5 mm), it may be too early to detect cardiac activity sonographically. (A more detailed discussion of sonographic interpretation and gestational dating can be found in the module titled "The Role of Ultrasound, hCG Assays, and Clinical Assessment in Medical Abortion.")
In this instance, ongoing pregnancy would still be the correct diagnosis if the post-treatment sonogram shows continuing development of the gestational sac or embryo. When the follow-up evaluation reveals a continuing pregnancy, surgical aspiration is indicated to complete the abortion.2
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After reading this section, you should be able to answer the following question:
What may indicate the presence of infection? |
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Uterine Infection
Uterine infection, or endometritis, is exceedingly rare following medical abortion, most likely because the procedure does not involve instrumentation of the uterus. Most medical abortion studies report no cases of infection. In large studies involving over 500 participants, infection rates typically vary from 0.09% to 0.5%.2 No data exist to support the universal use of antibiotic prophylaxis for medical abortion.
Endometritis can occur with or without retained tissue. In either case, patients can have a boggy, enlarged, and tender uterus. Ultrasound is a useful diagnostic aid: a thin endometrial stripe indicates an empty uterus, while a heterogeneous echoic collection suggests the presence of retained products or clots. The latter finding in a patient with symptoms and signs of infection warrants surgical evacuation of the uterus.2
Ascending infections of the uterus are usually polymicrobial in nature. For that reason, endometritis requires broad-spectrum antibiotic therapy. The Centers for Disease Control and Prevention (CDC) have issued guidelines for the management of pelvic inflammatory disease that include recommendations for specific antibiotic regimens.34
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After reading this section, you should be able to answer the following question:
When should ectopic pregnancy be suspected? |
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Ectopic Pregnancy
Ectopic pregnancy is a complication of pregnancy itself rather than a complication resulting from medical abortion treatment. For reasons that remain obscure, the rate of ectopic pregnancy in women presenting for early abortion is much lower than the rate of 1.9% for all pregnancies in the United States.
Of the approximately 3,000 patients involved in trials by the Spitz group3 and the Peyron group,14 only one case of ectopic pregnancy was reported. The incidence of ectopic pregnancy among patients seeking early surgical abortion at < 6 weeks' gestation is 6.7 per 1,000.9
Given that patients seeking medical abortion present to their providers early in pregnancy, the critical time for diagnosis of ectopic gestation, providers must remain vigilant to detect this complication, and have clear, established protocols for diagnosis and management.
At the initial visit, women with ectopic pregnancy may be asymptomatic or report a history of lower abdominal pain or intermittent bleeding. The pelvic examination may be normal or reveal an adnexal mass. Standard diagnostic evaluation includes pelvic ultrasound examination and quantitative ß-hCG measurements.
In normal pregnancy, experienced sonographers using a transvaginal probe should see a gestational sac within the uterus by the time the ß-hCG level reaches approximately 2,000 mIU/mL. Failure to do so indicates ectopic pregnancy until proven otherwise. The presence of a gestational sac with a yolk sac or embryonic cardiac activity within the fallopian tube establishes the diagnosis, but these findings are not invariably present.
Salpingectomy remains the most commonly performed surgical procedure for treatment of ectopic pregnancy in the United States.35 Over the past 20 years, however, surgical procedures to preserve the oviduct have been developed. In many cases of early unruptured ectopic pregnancy, medical management is another therapeutic option.36
Methotrexate, although it is not FDA-approved for this indication, is the only abortifacient that has proven useful in treating ectopic pregnancy,37 although it is not 100% effective.38 Mifepristone is ineffective in treating tubal pregnancy, possibly because the fallopian tubes lack progesterone receptors.39 Misoprostol also is not effective for the treatment of ectopic pregnancy.
The 50 mg/m2 dose of intramuscular methotrexate used in early medical abortion regimens is the same as that used in single-dose methotrexate protocols for treatment of unruptured ectopic pregnancy. In a recent study of 350 women treated with methotrexate for ectopic pregnancy, success rates correlated inversely with pretreatment serum ß-hCG levels and the presence of embryonic cardiac activity.40
Success rates decreased from 98% at ß-hCG concentrations < 1,000 mIU/mL to 93% at concentrations of 1,000 mIU/mL to 1,999 mIU/mL and to 92% at levels of 2,000 mIU/mL to 4,999 mIU/mL. Close clinical and ß-hCG monitoring is essential after methotrexate administration, because tubal rupture can occur even with declining serum concentrations of ß-hCG.38
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Death
Reports of death after medical abortion are very rare - less than 1 in 100,000 cases, a rate comparable to that for early surgical abortion and for miscarriage.41
Since the year 2000, more than 950,000 women in the United States have undergone mifepristone-induced abortion. Six women in North America have died as a result of toxic shock secondary to a rare bacterial infection of the uterus following medical abortion with mifepristone and misoprostol. This type of fatal infection has also been observed to occur following miscarriage, childbirth and surgical abortion, as well as other contexts unrelated to pregnancy.42,43 The Centers for Disease Control and Prevention's continuing investigations have found no causal link between the medications and these incidents of infection.43,44
Although the Food and Drug Administration (FDA) has issued an updated advisory for warning signs of infection following medical abortion in April of 2006, it has recommended that there be no changes in the current standards for provision of medical abortion.44,45 The FDA does not have sufficient information to recommend the use of prophylactic antibiotics. Reports of fatal sepsis in women undergoing medical abortion are very rare. Prophylactic antibiotic use carries its own risk of serious adverse events such as severe or fatal allergic reactions. Also, prophylactic use of antibiotics may contribute to the development of multi-drug resistant bacteria. Finally, it is not known which antibiotic and regimen (what dose and for how long) will be effective in preventing these rare fulminant infections.43,46
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 Proceed to Vacuum Aspiration as a Backup for Medical Abortion.
References for this module
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