The Safety and Quality of Current Abortion Methods
In the more than 40 years since national legalization of abortion, investigators have conducted randomized controlled trials (RCTs), large retrospective cohort studies, patient and provider surveys, systematic reviews, and other types of research on abortion care and its health effects on women, resulting in an extensive literature. The objective of this chapter is to examine this literature, focusing on the safety and effectiveness of current abortion methods and the extent to which these methods could expose women to the risk of such serious complications as the need for blood transfusion, surgery, or hospitalization. The chapter also examines whether the type of facility or method of sedation or anesthesia affects the risk of adverse outcomes. The chapter is organized as follows:
- The first section describes the clinical assessment, informed consent, patient education, and counseling that precede the abortion procedure.
- The second section addresses the initial clinical assessment.
- The next section describes current abortion methods and, for each method, reviews what is known about the procedure’s effectiveness, expected side effects, and risk of complications. Note that, for the purposes of this review, efficacy or effectiveness refers to the successful completion of the abortion without the need for a follow-up aspiration.
- The fourth section turns to postabortion care.
- The fifth section examines the evidence on the use of analgesia, sedation, and anesthesia in abortion care, including its safety and implications for the site of care.
- The following section compares the mortality rates for abortion and other common outpatient procedures.
- The next section presents a brief discussion of state regulation of abortion care.
- The final, summary section reviews state regulation of abortion safety in light of the clinical evidence presented earlier in the chapter.
The committee’s review emphasizes contemporary approaches to abortion care because abortion methods have been refined in response to new evidence. Some research conducted before 2000 is unlikely to reflect the outcomes of how abortions are typically performed in the United States today. As discussed below, for example, the U.S. Food and Drug Administration (FDA)-approved protocol for medication abortion was updated in 2016 based on extensive research showing improved outcomes with a revised regimen (CDER, 2016). Techniques used in aspiration procedures are also safer and more effective than in the past. Sharp metal curettes, once commonly used, are considered obsolete by many professional groups, and their use is no longer recommended for abortion because of the increased (albeit rare) risk of injury (NAF, 2017a; RCOG, 2011, 2015; Roblin, 2014; SFP, 2013; WHO, 2012). New approaches to cervical preparation and the use of ultrasound guidance have also improved abortion safety (Darney and Sweet, 1989; SFP, 2013).
This chapter draws primarily on the scientific literature but also includes the recommendations (i.e., clinical practice guidelines and best practices) of professional groups that provide obstetrical and gynecological care or are concerned with the quality of abortion services. Appendix D summarizes the literature search strategies the committee used to identify the relevant evidence, while Table 2-1 describes the sources of the clinical guidelines cited throughout this report.
When women seek an abortion, they present with a variety of experiences and needs (Moore et al., 2011; Zurek et al., 2015). Patient-centeredness—a fundamental attribute of quality health care—means “providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions” (IOM, 2001, p. 6). Thus, when women seek an abortion, they should have the opportunity to discuss their questions and concerns and receive support in their decision making. They should also
TABLE 2-1 Selected Organizations That Issue Clinical Guidelines on Abortion Care
|American College of Obstetricians and Gynecologists (ACOG)||A professional membership organization of obstetricians and gynecologists. ACOG produces clinical guidelines and other educational materials for its members and patients.|
|National Abortion Federation (NAF)||A standards-based membership organization of abortion facilities (clinics, physicians’ offices, and hospitals). To qualify for and maintain NAF membership, providers must meet NAF clinical and safety standards. The standards are revised annually to reflect current evidence and are the basis for members’ certification.|
|Royal College of Obstetricians and Gynaecologists (RCOG)||A global reproductive health professional society based in the United Kingdom. Its more than 14,000 members include individuals involved in obstetrics or gynecology worldwide. RCOG’s mission is to improve the standard of care and to advance the science and practice of obstetrics and gynecology.|
|Society of Family Planning (SFP)||A professional membership organization for qualified individuals who have an interest in family planning demonstrated through training, clinical or laboratory practice, or academic publication. SFP develops clinical guidelines and supports research on contraception and abortion.|
|World Health Organization (WHO)||The international public health organization of the United Nations, based in Geneva, Switzerland. WHO develops clinical guidelines on reproductive health care with the stated objective of improving health outcomes.|
SOURCES: ACOG, 2017a; NAF, 2017b; RCOG, 2017; SFP, 2017; WHO, 2017.
be provided evidence-based information on their procedure options so they can make an informed and independent decision.
There is little evidence on how preabortion care is typically provided, but there is consensus among professional guidelines that the preabortion encounter includes the following elements (Baker and Beresford, 2009; NAF, 2017a; RCOG, 2015; WHO, 2014):
- individualized, sensitive, and respectful communication;
- cultural sensitivity;
- review of the risks and benefits of the available abortion procedures that is based on evidence and is easy to understand;
- options for pain management, including nonpharmaceutical approaches, analgesia, sedation, and anesthesia;
- support for emotional and other needs as they arise;
- confirmation that the abortion decision is voluntary (not coerced);
- explanation of what will be done before, during, and after the procedure, including the preabortion evaluation;
- description of what the patient is likely to experience, clear instruction on aftercare, and how to recognize potential complications requiring emergency care;
- whom to call and where to go for services for both routine and follow-up care; and
- information and counseling on future prevention of unintended pregnancy and contraceptive options, including the option to obtain contraception immediately following the procedure.
Patient education, counseling, and informed consent are overlapping components of preabortion care. Patient education refers to the information women should receive regarding the available treatment options and the risks and benefits of these options (Baker and Beresford, 2009). It is also integral to the informed consent process—a legal and ethical obligation to all patients defined by state and federal law, malpractice standards, and professional standards (ACOG, 2015; AMA, 2016; Joint Commission Resources, 2016; Kinnersley et al., 2013). Counseling involves addressing the patient’s emotions, expectations, and beliefs about abortion care (Baker and Beresford, 2009).
Health care providers are legally required to obtain patients’ informed consent before performing a medical procedure. Specific definitions of informed consent may vary from state to state, but the goal of the informed consent process is well established: to ensure that patients understand the nature and risks of the procedure they are considering and that their decision to undergo it is voluntary (AAAHC, 2016; AMA, 2016; HHS, 2017a; Joint Commission, 2016). The discussion should also include options for analgesia, sedation, or anesthesia, including their associated risks and benefits (AANA, 2016; ASA Committee on Ethics, 2016).
Not every woman wants or needs psychological counseling in addition to patient education before an abortion (Baker and Beresford, 2009; Baron et al., 2015; Brown, 2013; Moore et al., 2011). Some women may wish to discuss the emotional aspects of the abortion with a counselor (Moore et al., 2011), and individualized counseling may be helpful for women having difficulty with their decision (Baker and Beresford, 2009). Women should also be referred to and have access to additional counseling and social services if needed (e.g., for counseling on intimate partner violence, sexual abuse care, rape crisis counseling, mental health services, substance abuse services, and postabortion counseling) (Goodman et al., 2016). As noted in Chapter 1, most women who undergo abortions are poor or low-income. Three-quarters of abortion patients have family incomes below 200 percent of the federal poverty level (Jerman et al., 2016) and thus may benefit
from social support services. In addition, although the evidence is drawn largely from non-U.S. data (Australia, Canada, China, New Zealand, and the United Kingdom), epidemiological studies have shown that women who have abortions are disproportionately at risk of interpersonal and other types of violence (Bourassa and Berube, 2007; Evins and Chescheir, 1996; Fanslow et al., 2008; Fisher et al., 2005; Glander et al., 1998; Janssen et al., 2003; Keeling et al., 2004; Leung et al., 2002; Russo and Denious, 2001; Saftlas et al., 2010; Steinberg and Russo, 2008; Taft and Watson, 2007; Taft et al., 2004). Little is known about the extent to which abortion patients receive the follow-up social and psychological supports they need. A study of Finnish registry data provides some evidence that monitoring for mental health status in a follow-up visit after abortion may help reduce the consequences of serious mental health disorders (Gissler et al., 2015).
Providing evidence-based information on how to prevent a future unintended pregnancy—including the option to obtain contraception contemporaneously with the procedure—is a standard component of abortion care (Goodman et al., 2016; NAF, 2017a; RCOG, 2015; WHO, 2014). Contraception discussions should be patient-centered, based on principles of informed consent using evidence-based information on the contraceptive alternatives, and guided by the patient’s preferences (Goodman et al., 2016; RCOG, 2015). Most contraceptive methods can be administered safely immediately after an abortion (Fox et al., 2011; Goodman et al., 2016; Grimes et al., 2010; Okusanya et al., 2014; Patil et al., 2016; Sääv et al., 2012; WHO, 2014). Recent studies suggest improved contraceptive use with the placement of implants or the initiation of other contraceptive methods at the time of the abortion or when mifepristone is administered for an early medication abortion (Hognert et al., 2016; Raymond et al., 2016a; Whaley and Burke, 2015).
While numerous options for contraception are available, long-acting reversible contraception (LARC) methods are the most effective for pregnancy prevention (ACOG, 2017b; Winner et al., 2012). Further, they are associated with higher rates of continuation, even for adolescents and young women, and fewer repeat abortions compared with other forms of contraception (ACOG, 2017b; Ames and Norman, 2012; Diedrich et al., 2015; Goodman et al., 2008; Goyal et al., 2017; Kilander et al., 2016; Rose and Lawton, 2012; Rosenstock et al., 2012; Winner et al., 2012). A prospective cohort study of women of reproductive age in the St. Louis area—the Contraceptive CHOICE project—assessed the impact of an educational intervention designed to increase awareness of LARC among women who wanted to avoid pregnancy for at least 1 year. The 10,000 women who enrolled in the project had the opportunity to obtain the contraceptive method of their choice at no cost in a variety of clinical settings where they received family planning, obstetrical, gynecological, and primary care (including two facilities
providing abortion care) (McNicholas et al., 2014; Secura et al., 2010). The study found that offering LARC at the time of enrollment was well received; 75 percent of the 9,256 participants opted for intrauterine devices (IUDs) or implants. LARC users were more likely than non-LARC users to continue using contraception at 12 and 24 months (86 percent versus 55 percent at 12 months, 77 percent versus 41 percent at 24 months). The generalizability of these findings, however, is uncertain given that the contraceptives were free, and the study population included only women who wanted to avoid pregnancy. The CHOICE study also evaluated a structured approach to contraceptive counseling and found that counseling could be provided effectively by trained personnel without a medical background (Madden et al., 2013).
INITIAL CLINICAL ASSESSMENT
Abortion care should always begin with a clinical evaluation, including a pertinent medical history and clinical assessment to assess the presence of comorbidities or contraindications relevant to the procedure. The primary aim of the evaluation is to confirm an intrauterine pregnancy and determine gestation. The physical exam may involve laboratory tests and ultrasonography to confirm an intrauterine pregnancy; assess gestation; screen for sexually transmitted infections (STIs) and cervical infections; document Rh status; or evaluate uterine size, position, and possible anomalies (ACOG and SFP, 2014; Goldstein and Reeves, 2009; Goodman et al., 2016; NAF, 2017a; RCOG, 2015; WHO, 2014). Women whose Rh status is unknown should be offered Rh testing and, if Rh negative, offered Rh immune globulin (ACOG and SFP, 2014, NAF, 2017a; RCOG, 2015). No evidence, however, indicates that Rh immune globulin is needed in pregnancies under 8 weeks’ gestation (NAF, 2017a). While it should not delay the abortion procedure, screening for STIs may be appropriate if available (NAF, 2017a; RCOG, 2015). The contraindications and other circumstances affecting the appropriateness of each abortion method are discussed later in the chapter.
Pregnancy is dated from the first day of the last menstrual period (LMP) and is commonly measured by days’ or weeks’ gestation (Goldstein and Reeves, 2009). Either clinical evaluation or ultrasound examination can be used to establish gestation (ACOG and SFP, 2014; WHO, 2014). Ultrasound is not required, however, and there is no direct evidence that it improves the safety or effectiveness of the abortion (Kaneshiro et al., 2011; NAF, 2017a; Raymond et al., 2015; RCOG, 2015). In a study of nearly 4,500 medication abortion patients aimed at assessing the feasibility and efficacy of foregoing routine use of ultrasound, Bracken and colleagues (2011) found that LMP date combined with physical examination was
highly effective at determining eligibility for medication abortion—patients accurately assessed their eligibility (Bracken et al., 2011).
SAFETY AND EFFECTIVENESS OF CURRENT ABORTION METHODS
Several methods—medication, aspiration, dilation and evacuation (D&E), and induction—are used to perform an abortion depending on weeks’ gestation, patient preference, provider skill, need and desire for sedation, costs, clinical setting, and state policies and regulations.
Medication abortion in early pregnancy is accomplished using mifepristone, a progesterone receptor antagonist that competitively interacts with progesterone at the progesterone receptor site, thereby inhibiting the activity of endogenous or exogenous progesterone. This process initiates the breakdown of the endometrium and implanted embryo (Borkowski et al., 2015). Mifepristone, sold under the brand name Mifeprex,1 is the only medication specifically approved by the FDA for use in medication abortion (Woodcock, 2016). Taken orally, it has been shown to increase sensitivity to prostaglandins and is most commonly used in conjunction with misoprostol, a prostaglandin E1 analogue. Misoprostol causes uterine contractions as well as cervical ripening and can be administered orally, sublingually, buccally, or vaginally.2 Since mifepristone’s initial FDA approval in 2000, an extensive body of research has led to improvements in the drug’s protocol, including a lower recommended dosage, an increased period of eligibility from 49 days’ to 70 days’ (10 weeks’) gestation, and a recommendation that the misoprostol be taken buccally rather than sublingually or orally to minimize side effects (Borkowski et al., 2015; Chai et al., 2013). The World Health Organization (WHO) has included mifepristone and misoprostol on its Model List of Essential Medicines since 2005 (WHO, 2015).3
Few women have contraindications to medication abortion (ACOG and SFP, 2014). The FDA-approved Mifeprex label states that the drug should not be used for women with confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass; an IUD in place; chronic adrenal
1 Mifeprex is manufactured and distributed by Danco Laboratories. Danco is the only distributer of Mifeprex in the United States.
2 A sublingual medication is dissolved under the tongue. Buccal medications are placed between the gums and the cheek.
3 Where permitted under national law and where culturally acceptable (WHO, 2015).
failure; concurrent long-term systemic corticosteroid therapy; hemorrhagic disorders or concurrent anticoagulant therapy; allergy to mifepristone, misoprostol, or other prostaglandins; or inherited porphyrias (FDA, 2016a).
Since 2011, the distribution and use of Mifeprex has been restricted under the requirements of the FDA Risk Evaluation and Mitigation Strategy (REMS) program (see Box 2-1). (See Chapter 3 for additional details on REMS requirements for clinicians who prescribe Mifeprex.) Despite the restriction, use of the medication method is increasing, especially in early pregnancy. As noted in Chapter 1, the percentage of all abortions by medication rose by 110 percent between 2004 and 2013 and is expected to increase further (Jatlaoui et al., 2016). In 2014, medication abortions accounted for approximately 45 percent of all U.S. abortions performed <9 weeks’ gestation (Jones and Jerman, 2017).
Effectiveness of the Current Medication Regimen
The current FDA-approved regimen for medication abortion is 200 mg of mifepristone taken orally, followed by 800 mcg of misoprostol taken buccally 24 to 48 hours later (FDA, 2016a). A recent systematic review of this regimen—including 33,846 medication abortions—found an overall effectiveness rate of 96.7 percent for gestations up to 63 days (9 weeks) (Chen and Creinin, 2015).4
4 The review also included 332 abortions that were performed between 64 and 70 days’ gestation; the efficacy rate for these procedures was 93.1 percent.
Reversal of Medication Abortion
There has recently been media attention to claims that medication abortions can be “reversed” by taking progesterone after the mifepristone but before taking the misoprostol (Graham, 2017). The claims are based on a case series report of seven patients who did not receive standardized doses or formulations of the medications (i.e., mifepristone or progesterone) (Delgado and Davenport, 2012). Case series are descriptive reports that are considered very low-quality evidence for drawing conclusions about a treatment’s effects (Guyatt et al., 2011). In a related subsequent systematic review, Grossman and colleagues (2015) assessed the likelihood of a pregnancy continuing if the abortion medication regimen is not completed (i.e., the mifepristone dosage is not followed by misoprostol). However, the review found that there were insufficient data to conclude that the progesterone treatment is more likely to lead to continued pregnancy compared with expectant management after mifepristone alone.
Expected Side Effects
It is common for medical procedures to result in side effects in addition to the intended outcome. Medication abortions involve cramping, pain, and bleeding, similar to the symptoms of a miscarriage (ACOG and SFP, 2014; Borkowski et al., 2015; FDA, 2016a). Vaginal bleeding is expected during and after an abortion and occurs in almost all patients during a medication abortion (FDA, 2016a). Bleeding generally starts as the tissue begins to separate from the endometrium and continues for several days after the abortion is complete. The heaviest bleeding occurs during and immediately following the passage of the gestational sac and lasts 1 to 2 days. Some bleeding and spotting may occur up to 9–16 days.
Like bleeding, uterine pain and cramping are an expected and normal consequence of medication abortion (FDA, 2016a). Cramping can last from a half-day to 3 days (Ngo et al., 2011). Nonsteroidal anti-inflammatory drugs (NSAIDs) are typically recommended to manage the pain. Ibuprofen—after the onset of cramping—has been shown to reduce both pain and later analgesia use (Jackson and Kapp, 2011; Livshits et al., 2009). However, some women still report high levels of pain, and pain is commonly reported as the worst feature of the method. Prophylactic regimens for pain management are an area of active research (Dragoman et al., 2016).
Other side effects reported by women who undergo medication abortion include nausea, vomiting, weakness, diarrhea, headache, dizziness, fever, and chills (Chen and Creinin, 2015; FDA, 2016a). About 85 percent of patients report at least one of these side effects, and many patients are expected to report more than one (FDA, 2016a).
Complications after medication abortion, such as hemorrhage, hospitalization, persistent pain, infection, or prolonged heavy bleeding, are rare—occurring in no more than a fraction of a percent of patients (Chen and Creinin, 2015; FDA, 2016a; Ireland et al., 2015; Kulier et al., 2011; Woodcock, 2016). Obesity (i.e., a body mass index [BMI] of 30 or greater) has not been found to increase the risk for adverse outcomes after medication abortion (Strafford et al., 2009). The Society of Family Planning suggests that medication abortion may be preferable to aspiration abortion when patients, including those with extreme obesity, are at risk of procedural and anesthetic complications (SFP, 2012).
Hemorrhage Prolonged heavy bleeding is rare but may indicate an incomplete abortion5 or other complications. Hemorrhage requiring assessment or treatment following medication abortion is also rare. The FDA advises that women contact a health care provider immediately if bleeding after a medication abortion soaks through two thick full-size sanitary pads per hour for two consecutive hours (FDA, 2016a). In a study of 11,319 medication abortions performed in California between 2009 and 2010, hemorrhage occurred in 16 cases (0.14 percent) (Upadhyay et al., 2015).
The need for a blood transfusion—an uncommon occurrence—is an indication of clinically significant hemorrhage. In a study of more than 1,000 women receiving medication abortion in Norway, 1 patient required a transfusion (0.1 percent) and 32 required an aspiration procedure because of continued bleeding (3.0 percent) (Løkeland et al., 2014). In Chen and Creinin’s (2015) systematic review of 20 studies and 33,846 women (described above), 0.03 to 0.6 percent of women required a blood transfusion after a medication abortion.
Infection Serious infection occurs rarely after medication abortion; reports of fatal sepsis are exceedingly rare (<1 in 100,000) (FDA, 2011; Woodcock, 2016). Signs and symptoms of serious infection are fever of 100.4°F or higher lasting more than 4 hours, tachycardia, severe abdominal pain, pelvic tenderness, or general malaise with or without fever occurring more than 24 hours after administration of misoprostol (ACOG and SFP, 2014; FDA, 2016a). There is no evidence of a causal relationship between use of mifepristone and misoprostol and an increased risk of infection or death (FDA, 2016a; Woodcock, 2016). The incidence of infection in recent studies ranges from 0.01 to 0.5 percent (Chen and Creinin, 2015; Cleland et
5 An “incomplete abortion” occurs when parts of the products of conception are retained in the uterus.
al., 2013; Upadhyay et al., 2015). According to the FDA’s Adverse Event Reporting System, there were nine reports of severe bacterial infections following medication abortion from November 1, 2012, through April 30, 2015 (Woodcock, 2016). The FDA has concluded that the available evidence does not support the use of prophylactic antibiotics for medication abortion (CDER, 2016).
Need for uterine aspiration Some women require a uterine aspiration after medication abortion because of retained products of conception, persistent pain or bleeding, or ongoing pregnancy (Chen and Creinin, 2015; Cleland et al., 2013; Ireland et al., 2015; Raymond et al., 2013; Upadhyay et al., 2015). Ireland and colleagues (2015) analyzed more than 13,000 electronic medical records documenting the outcomes of medication abortions (up to 9 weeks’ gestation) performed in private Los Angeles clinics from November 2010 to August 2013. Of these, 2.1 percent required an unanticipated uterine aspiration either because of an ongoing pregnancy (0.4 percent) or for persistent pain, bleeding, or both (1.8 percent). Other recent estimates of the need for an unanticipated uterine aspiration range from 1.8 to 4.2 percent (Chen and Creinin, 2015). Rates vary in part because of differences in study populations (including weeks’ gestation) and in treatment regimens (Cleland et al., 2013; Raymond et al., 2013; Upadhyay et al., 2015).
Impact of Clinical Setting on the Safety and Effectiveness of Medication Abortion
There is no direct evidence suggesting that specific types of facilities (e.g., ambulatory surgery centers or hospitals) or facility factors (e.g., size of procedure room or corridor width) are needed to ensure the safety of medication abortion. Indeed, most women in the United States return home after taking mifepristone and take the misoprostol 28 to 48 hours later. As a result, medication abortions occur largely in nonclinical settings. Moreover, as described above, a body of research including systematic reviews (Chen and Creinin, 2015; Kulier et al., 2011; Raymond et al., 2013) and large cohort studies (Cleland et al., 2013; Ireland et al., 2015; Upadhyay et al., 2015) demonstrates that complications such as infection, hemorrhage requiring transfusion, or hospitalization occur in fewer than 1.0 percent of patients.
Some research has focused specifically on medication abortion outside the hospital or clinic setting. A variety of studies, for example, have assessed the self-administration of misoprostol after receiving mifepristone in a clinic. This largely observational research shows that home use of misoprostol produces outcomes similar to those of the clinic-supervised method (Clark
et al., 2005; Fiala et al., 2004; Guengant et al., 1999; Løkeland et al., 2014; Ngoc et al., 2004; Shannon et al., 2005; Shrestha and Sedhai, 2014).
Other research has assessed the safety and effectiveness of home use of both mifepristone and misoprostol (Chong et al., 2015; Conkling et al., 2015; Platais et al., 2016). In one U.S. prospective nonrandomized study, 400 women with pregnancies up to 63 days’ gestation were offered the choice of either clinic-supervised or home use of mifepristone. Of these women, 128 chose home administration, and 272 chose clinic administration; the women did not differ significantly in terms of gravidity, gestation, or other measured characteristics. The women choosing home use were slightly older (27.8 versus 26.0 years) and more likely to be doing paid work (78.9 versus 68.0 percent). Success rates did not differ between the groups (96.3 versus 96.9 percent), and the 2 patients who required hospitalization were in the clinic-supervised group. One patient was diagnosed with an incomplete abortion and underwent a follow-up dilation and curettage procedure, and the other was treated for severe nausea and vomiting (Chong et al., 2015). A related study found that among 301 women offered the choice of home use, the factor most cited by women who chose this option was flexibility in scheduling (Swica et al., 2013).
Telemedicine is the use of telecommunications and information technology to provide access to health assessment, diagnosis, intervention, consultation, supervision, and information across distance (HHS, 2017b). For medication abortion, the process involves a health care provider’s reviewing the relevant medical information and having a discussion with the patient via teleconference. If clinical criteria are met, the health care provider remotely dispenses or issues a prescription for the medication abortion regimen (Aiken et al., 2018; Grossman et al., 2011a). Grossman and colleagues (2011a) investigated the effectiveness and acceptability of telemedicine for medication abortion (mean days’ gestation was 47 days) compared with face-to-face physician visits in Iowa. Roughly half of the 578 patients were enrolled in the telemedicine option. The success rates for the two options were similar: 98.7 percent for the telemedicine patients and 96.9 percent for the clinic patients. No patient in either group required hospitalization, and there was no significant difference in the occurrence of adverse events. One of the 223 patients in the telemedicine group received a blood transfusion. In a recent 7-year retrospective cohort study in Iowa, researchers compared the rate of clinically significant adverse events (hospital admission, surgery, blood transfusion, emergency department treatment, or death) after medication abortion for 8,765 telemedicine patients and 10,405 in-person patients (Grossman and Grindlay, 2017). The overall rate of adverse events
was less than 0.3 percent. The difference between the telemedicine patients (0.18 percent) and in-person patients (0.32 percent) was not statistically significant and was within the authors’ margin of noninferiority. This finding indicates that telemedicine provision of medication abortion was not associated with a significantly higher prevalence of adverse events compared with in-person provision.
These reported risks are both low and similar in magnitude to the reported risks of serious adverse effects of commonly used prescription and over-the-counter medications. For example, it has been estimated that the use of NSAIDs is responsible for 3,500 hospitalizations and 400 deaths per year in UK residents aged 60 or older, a risk rate of 0.23 and 0.03 percent, respectively (Hawkey and Langman, 2003). The NSAID-related risk of hospitalization in elderly Medicaid patients in the United States has been estimated to be even higher—1.25 percent in one study (Smalley et al., 1995). The risk of diarrhea with many common antibiotics is as high as 39 percent (McFarland, 1998), and the risk of hospitalization due to the more serious Clostridium difficile infection may be as high as 0.02 percent with some antibiotic combinations (Hirschhorn et al., 1994). Taken together, these findings provide additional indirect evidence that no facility-specific factors are needed to ensure the safety of medication abortion, as there is no perceived need for facility-specific factors to ensure the safety of these other common pharmaceuticals. These safety data accord with professional guidelines or best practices according to which routine early medication abortion does not require sophisticated settings and can be safely performed in settings typical for the delivery of women’s health care and family planning services (ACOG and SFP, 2014; NAF, 2017a; RCOG, 2015; WHO, 2014).
In their analysis of the Iowa study described above, Grossman and colleagues (2013) conducted a geographic analysis to assess the effect of the telemedicine model on access to medication abortion for women in different areas of the state. They found that the proportion of all Iowa abortions that were medication abortions had increased, from 33.4 to 45.3 percent (p <.001), in the 2-year periods before and after telemedicine was introduced. The increase was especially notable among women living in more remote areas. Women who lived more than 50 miles from an abortion clinic that provided only surgical abortions were 16 percent more likely to have a medication abortion (adjusted odds ratio [aOR] = 1.16; 95% confidence interval [CI] = 1.05, 1.28). The proportion of medication abortions at the study sites had also increased from 46 to 54 percent after telemedicine was introduced (p <.001). Overall, women in Iowa had a 46 percent greater likelihood of having an earlier abortion (<14 weeks’ gestation) (aOR = 1.46; 95% CI = 1.22, 1.75).
Aspiration is a minimally invasive and commonly used gynecological procedure (Meckstroth and Paul, 2009; Roblin, 2014).6 The procedure time is typically less than 10 minutes (Edelman et al., 2001; Goldberg et al., 2004). As noted in the previous chapter, aspiration is currently the most common abortion method used in the United States regardless of gestation, accounting for almost 68 percent of abortions in 2013.7 The method may be used up to 14 to 16 weeks’ gestation. Aspiration is also used in cases of early pregnancy loss (miscarriage) and management of incomplete abortion for medication abortion.
The first steps in the procedure are cervical dilation and priming (when appropriate) so that the contents of the uterus can be evacuated. Cervical dilation is usually done using tapered mechanical dilators and is recommended over routine priming except for adolescents and others for whom cervical dilation may be challenging (Allen and Goldberg, 2016). Cervical priming is accomplished with either osmotic dilators8 or pharmacological agents (e.g., misoprostol), or both. When placed in the cervix, the osmotic dilator absorbs moisture from the tissues surrounding the cervix and gradually swells to slowly open the cervical orifice (os). The pharmaceutical agents are prostaglandin analogues or progesterone antagonists, such as the drug misoprostol, which is also used in medication abortion.
After cervical dilation and, when indicated, priming, a suction cannula (plastic or metal tube) is inserted through the cervix into the uterus. The cannula is attached to a vacuum source—an electric vacuum pump for electric vacuum aspiration or a handheld, hand-activated aspirator (syringe) for manual vacuum aspiration—to empty the uterine contents. Ultrasound guidance is sometimes used (RCOG, 2011).
See later in this chapter for a discussion of the use of sedation and anesthesia during abortion procedures, including the implications for personnel needs and facility requirements.
6 There is no standard terminology for this type of abortion. As noted in Chapter 1, this report uses the term “aspiration abortion,” although others commonly refer to the same procedure as “surgical abortion,” “vacuum aspiration,” “suction curettage,” or “suction evacuation.”
7 Centers for Disease Control and Prevention (CDC) surveillance reports use the catchall category of “curettage” to refer to nonmedical abortion methods. The committee assumed that CDC curettage estimates before 13 weeks’ gestation refer to aspiration procedures and that curettage estimates after 13 weeks’ gestation are D&E procedures.
8 Laminaria, small tubes made of dried seaweed, and manmade sterile sponges are common types of osmotic dilators.
Effectiveness of Aspiration Abortion
Recent comparisons of aspiration and medication abortion methods indicate that aspiration may be only slightly more effective than medication abortion in early pregnancy. In Ireland and colleagues’ (2015) study of private Los Angeles clinics described in the prior section, the efficacy rate for almost 17,000 aspiration abortions performed up to 9 weeks’ gestation was 99.8 percent, compared with 99.6 percent for medication abortions9 for the same gestational period (Ireland et al., 2015).
Expected Side Effects
As in medication abortion, bleeding, uterine pain, and cramping are expected and normal consequences of aspiration abortion.
Aspiration abortions rarely result in complications. In a recent retrospective analysis of California fee-for-service Medicaid claims data, 57 of almost 35,000 women (0.16 percent) were found to have experienced a serious complication (hospital admission, surgery, or blood transfusion) after an aspiration abortion (Upadhyay et al., 2015). A systematic review on aspiration-related complications documents a somewhat higher complication rate (ranging from 0 to 5 percent), but a large proportion of the studies in that review included now outdated procedures, including dilation and sharp curettage (White et al., 2015).
In a historical cohort study, Guiahi and colleagues (2015) analyzed the outpatient medical records of women who had undergone an aspiration abortion between January 2009 and March 2014 in a Colorado clinic. The researchers compared the outcomes of women with (n = 587) and without (n = 1,373) medical comorbidities, including diabetes, hypertension, obesity (weight ≥200 lb or BMI ≥30), HIV, epilepsy, asthma, thyroid disease, and/or bleeding and clotting disorders having aspiration abortions. The researchers found no difference in the rate of complications between the women with at least one comorbidity and those with no comorbidity (odds ratio [OR] = 0.9; 95% CI = 0.5, 1.6).
Need for repeat aspiration Repeat aspiration is most often required for retained products of conception after an abortion. Rates of <0.1 to 8.0 percent have been reported for this complication, related to gestation, experience of the provider, and use of ultrasound guidance (White et al., 2015).
9 p <.001.
Studies showing the highest rates of repeat aspiration included women at ≤6 weeks’ gestation and were conducted more than 20 years ago (Bassi et al., 1994). Tissue inspection is recommended after aspiration abortion, regardless of gestation, but products of conception may be difficult to identify prior to 7 weeks’ gestation (NAF, 2017a; SFP, 2013). Additional protocols, including magnification of aspirate, follow-up by serum beta-hCG estimation, and flotation of tissue with backlighting may be used to confirm abortion completion (NAF, 2017a; RCOG, 2011; SFP, 2013).
Hemorrhage Hemorrhage requiring transfusion or other treatment (medication administration or repeat aspiration) complicates 0.0 to 4.7 percent of aspiration abortions, with more recent studies reporting a rate of 1.3 percent (Upadhyay et al., 2015; White et al., 2015). In the California Medicaid study, 0.13 percent of aspiration procedures were complicated by hemorrhage (Upadhyay et al., 2015).
Infection Current clinical guidelines recommend routine antibiotic prophylaxis before all aspiration abortions (NAF, 2017a; RCOG, 2015; SFP, 2011b; WHO, 2014). Like any invasive procedure, aspiration abortion carries some risk of infection. If untreated, an upper genital tract infection subsequent to abortion can lead to chronic pelvic pain, dyspareunia, ectopic pregnancy, and infertility (Low et al., 2012). Serious infection after aspiration, however, is rare. In a 2012 systematic review, the Cochrane Collaboration evaluated the effectiveness of perioperative antibiotics in preventing upper genital tract infection (including infection of the uterus and fallopian tubes) (Low et al., 2012). The researchers concluded that universal antibiotic prophylaxis is effective in preventing infection after an aspiration procedure: the incidence of upper genital tract infection among women who received prophylactic antibiotics was 59 percent of that among women who received a placebo. The rate of infection was 5.8 percent among women who received antibiotics (n = 3,525) and 9.4 percent among women in the placebo group (n = 3,500).
In a more recent systematic review of complications following aspiration abortion (up to 14 weeks’ gestation), White and colleagues (2015) report that 0.0 to 0.4 percent of 188,395 women undergoing aspiration abortions required intravenous (IV) antibiotics after the procedure in 11 of 12 office-based settings. In Upadhyay and colleagues’ (2015) analysis of almost 35,000 aspiration abortions in California, 94 women (0.27 percent) developed an infection after the procedure. Most infections after outpatient aspiration procedures are treated with oral antibiotics, with up to 0.4 percent of patients with infection requiring IV antibiotic administration (White et al., 2015).
Uterine perforation Uterine perforation involves injury to the uterine wall, as well as potential injury to other abdominal organs. While the risk of uterine perforation in older studies has been reported as ≤0.1 to 2.3 percent, the majority of more recent studies of aspiration abortion report no cases of uterine perforation or note that perforations that occurred were successfully managed conservatively without the need for additional surgery or hospitalization (White et al., 2015). In the study of almost 35,000 California Medicaid-covered aspiration abortions referenced above, 0.01 percent resulted in a perforation (Upadhyay et al., 2015).
Cervical laceration Cervical laceration (injury to the cervix from instrumentation) is also very rare, with most studies reporting none or 1 case (<0.1 to 0.6 percent) (Ohannessian et al., 2016; White et al., 2015). In a study evaluating the risks of aspiration abortion in teens versus adults, an increased risk of cervical laceration was noted for adolescent patients (0.5 versus 0.2 percent), but this study was conducted prior to current approaches to cervical preparation (Cates et al., 1983; White et al., 2015). Use of osmotic dilators was common in older studies, but the more common approach today is medical, using misoprostol 2 to 3 hours prior to the procedure (Allen and Goldberg, 2016; O’Connell et al., 2009). While current recommendations do not include routine use of medical or mechanical cervical preparation because of the delay that would result, misoprostol is commonly used in nulliparous women and young adolescents between 12 and 14 weeks’ gestation (Allen and Goldberg, 2016).
Dilation and Evacuation
Fewer than 9 percent of abortions in the United States occur after 13 weeks’ gestation (Jatlaoui et al., 2016). The D&E method, sometimes referred to as a second-trimester surgical abortion, appears to account for the majority of procedures performed between 14 and 20 weeks’ gestation. Precise estimates of the rate of abortions by type during these weeks are not available. Reports often cite CDC surveillance statistics as suggesting that D&Es account for up to 96 percent of abortions between 14 and 20 weeks’ gestation (ACOG, 2013; Hammond and Chasen, 2009). However, the oft-cited CDC data are actually aggregate estimates that include not only D&E but also other methods (Jatlaoui et al., 2016; Pazol et al., 2009).
D&E techniques have evolved in the decades since the method was first developed (ACOG, 2013; Hammond and Chasen, 2009; Lohr et al., 2008). The procedure is typically performed in two stages, although the specific approaches to cervical preparation, instrumentation, and other aspects may vary (Grossman et al., 2008; Ibis Reproductive Health, 2015; Lohr et al., 2008). The procedure itself generally takes less than 30 minutes
(Ben-Ami et al., 2009; Grossman et al., 2008, 2011b). The first step is cervical preparation, dilating the cervix with laminaria (or other type of osmotic dilator) and/or a prostaglandin (e.g., misoprostol). Slow dilation is recommended (e.g., over a few hours, overnight, or sometime repeated over 24 to 48 hours) to minimize the need for supplemental manual or mechanical dilation (Grossman et al., 2008; Lohr et al., 2008). With a greater degree of dilation, the uterus is more easily emptied, instruments are easier to use, and procedure time is shortened (Hern, 2016). Once dilation is adequate and analgesia, sedation, and/or anesthesia have been administered, the amniotic fluid is aspirated (Lohr et al., 2008; WHO, 2014). Before 16 weeks’ gestation, suction aspiration may suffice to empty the uterus. At 16 weeks, forceps extraction may also be required. Beyond 16 weeks, suction is not effective, and forceps should be used to remove fetal parts and the placenta. A curette and/or additional suction are also used to remove any remaining tissue or blood clots. Following the procedure, the provider examines the tissue to confirm that the evacuation was complete. Patients should be observed following the procedure to monitor for any postoperative complications (Hammond and Chasen, 2009; Lohr et al., 2008).
Ultrasonography is recommended so the physician can visualize the surgical instruments, locate fetal parts, and confirm an empty uterus (NAF, 2017a). Routine intraoperative ultrasonography has been demonstrated to significantly reduce the risk of uterine perforation and shorten the time required to complete the procedure (Darney and Sweet, 1989).
Performing D&E procedures requires advanced training and/or experience (Cates et al., 1982; Hern, 2016; Lohr et al., 2008; RCOG, 2015; WHO, 2012). Chapter 3 reviews the required clinical skills for performing abortions.
Although the risk of complications increases with weeks’ gestation (Bartlett et al., 2004; Grossman et al., 2008; Zane et al., 2015), a range of retrospective cohort studies, case series, chart reviews, and a prospective case series have shown D&E to be effective with minimal rates of complications, ranging from 0.05 to 4 percent (ACOG, 2013; Autry et al., 2002; Bryant et al., 2011; Cates et al., 1982; Frick et al., 2010; Grimes et al., 1977; Grossman et al., 2008; Jacot et al., 1993; Mauelshagen et al., 2009; Peterson et al., 1983).
One study, however, suggests that a history of multiple prior cesarean deliveries may significantly increase the risk of a major complication. In a multivariable logistic analysis of 2,973 D&Es performed between 2004 and 2007 at an urban public hospital, Frick and colleagues (2010) found
an overall rate of major complications (i.e., transfusion required; disseminated intravascular coagulation; or a reoperation involving uterine artery embolization, laparoscopy, or laparotomy) of about 1.0 percent. However, women with two or more prior cesarean sections had a sevenfold increased risk of a major complication (OR = 7.37; 95% CI = 3.35, 15.80) (Frick et al., 2010). A history of one prior cesarean section was not associated with an increased risk of complications, although the authors note that a larger sample might lead to different results.
Obesity has also been studied as a possible risk factor for women undergoing D&E abortions (Benson et al., 2016; Lederle et al., 2015; Murphy et al., 2012). In a retrospective cohort study of 4,968 women undergoing aspiration and D&E abortions at a large outpatient clinic in 2012–2014, obesity was not associated with increased risk of complications10 (Benson et al., 2016). The same conclusion resulted from a retrospective cohort study of 4,520 D&Es performed in a hospital-based abortion practice in 2009–2013 and a retrospective review of 1,044 women undergoing D&E or dilation and suction (D&S)11 between 13 and 24 weeks’ gestation in 2007–2010 (Lederle et al., 2015; Murphy et al., 2012). Lederle and colleagues (2015) found no association between BMI and D&E complications12 after adjustment for age, ethnicity, prior vaginal delivery, prior cesarean delivery, and gestational duration. Murphy and colleagues (2012) compared complication rates, operative times, and anesthesia times between obese and nonobese (BMI <30) women and found no significant difference in complication rates. Finally, a retrospective analysis of D&E procedures performed between 2009 and 2014 found an association between obesity and increased risk for complications13 in abortions performed after 14 weeks’ gestation (Mark et al., 2017). Complications increased by BMI category,14 and the increase in
10 Complications assessed included need for uterine reaspiration (including same-day reaspiration), uterine perforation, cervical laceration, infection, emergency department visit or hospitalization, and excessive blood loss (defined as estimated blood loss greater than or equal to 100 mL).
11 Dilation and curettage/suction denoted procedures performed when no other instruments besides suction were used; 5.3 percent of procedures in the study were D&S.
12 Complications assessed included cervical laceration, hemorrhage, uterine atony, anesthesia complications, uterine perforation, disseminated intravascular coagulation, retained products of conception, and major complications (defined as those requiring hospitalization, transfusion, or further surgical intervention).
13 Complications assessed included hemorrhage, need for repeat evacuation, uterine perforation, cervical laceration, medication reaction, unexpected surgery, or unplanned admission to the hospital.
14 The cohort was classified into categories based on the WHO classification of underweight (BMI <18.5), normal weight (BMI 18.5–24.9), overweight (BMI 25.0–29.9), obese Class I (BMI 30–34.9), obese Class II (BMI 35–39.9), and obese Class III (BMI 40 or greater).
complications in women with Class III obesity was significant (OR = 5.04; 95% CI = 1.65–15.39).
Hemorrhage In studies of abortions performed in the year 2000 or later, D&E-related hemorrhage requiring transfusion or other treatment occurred in 0.0 to 1.0 percent of cases (Frick et al., 2010; Grossman et al., 2011a; Mauelshagen et al., 2009).
Infection Routine antibiotic prophylaxis is recommended for all surgical abortions (ACOG, 2013; NAF, 2017a; RCOG, 2015; WHO, 2014). Infection after a D&E is uncommon, with rates ranging from 0.0 to 2.0 percent (Autry et al., 2002; Grossman et al., 2011a; Mauelshagen et al., 2009). In the California Medicaid study described above, Upadhyay and colleagues (2015) found that 0.3 percent or 18 of 8,837 abortions performed after 13 weeks’ gestation resulted in an infection, although these procedures included both D&Es and inductions.
Cervical lacerations Injuries to the cervix and uterus have decreased significantly with routine cervical preparation prior to D&E (ACOG, 2013). Recent studies have reported rates of 0.02 to 3.3 percent (Autry et al., 2002; Frick et al., 2010). The risk of cervical laceration is associated with mechanical dilation, nulliparity, advanced gestation, and provider inexperience (ACOG, 2013). Thus, as noted above, performing D&E procedures requires advanced training and/or experience.
Uterine perforation While uterine perforation is more common in D&E than in aspiration procedures, the incidence remains quite low and is likely related to the availability of cervical preparation and ultrasound guidance (Grossman et al., 2008). Limited clinician experience and underestimation of the duration of pregnancy are also factors that have been associated with uterine perforation (Grossman et al., 2008). A 1989 study compared the incidence of perforation during 810 D&E procedures with and without sonography (Darney and Sweet, 1989). Using ultrasound to guide the use of intrauterine forceps clearly improved the safety of the procedure: the rate of perforation declined significantly from 1.4 to 0.2 percent. Studies dating from 2010 to 2015 report perforation rates ranging from 0.2 to 0.8 percent (Frick et al., 2010; Upadhyay et al., 2015).
The facility requirements that are appropriate for D&Es depend on the level of sedation and anesthesia that is used. (See later in this chapter for a review of the use of analgesia, sedation, and anesthesia during abortions.)
As noted in Chapter 1, abortion terminology can be confusing. All abortion methods are sometimes referred to as “induced,” and the term “medical” is often used to describe any nonsurgical method regardless of how early or late in pregnancy it occurs. In this section, the term “induction abortion” refers specifically to nonsurgical abortions that use medications to induce labor and delivery of the fetus. Relevant research and clinical guidelines use varying lower and upper gestation limits. In practice, the gestational parameters for induction vary depending on the facility, patient and provider preference, and state laws and regulations (SFP, 2011a).
Induction abortions are rarely performed in the United States; in 2013, they accounted for approximately 2 percent of all abortions at 14 weeks’ gestation or later (Jatlaoui et al., 2016). For many women in the United States, D&E is often the preferred alternative because induction is more painful, its timing is less predictable and slower (sometimes taking more than 24 hours), and it is more expensive (see below) (ACOG, 2013; Ashok et al., 2004; Grimes et al., 2004; Grossman et al., 2008; Kelly et al., 2010; Lohr et al., 2008). In some clinical settings, however, D&E is not an option because the available clinicians lack the necessary experience and/or training in D&E procedures (SFP, 2011a).15 In addition, D&E abortions are illegal in Mississippi and West Virginia.16
Optimal Medication Regimen for Induction Abortions
The medication regimens for performing an induction abortion have evolved and improved in response to a growing body of research—most notably with respect to the combined use of mifepristone and misoprostol (Gemzell-Danielsson and Lalitkumar, 2008; Wildschut et al., 2011). The safety and efficacy of different medications and medication regimens for inducing abortion has been assessed in RCTs, retrospective analyses, prospective observational studies, and systematic reviews (Ashok et al., 2002, 2004; Constant et al., 2016; Goh and Thong, 2006; Gouk et al., 1999; Hamoda et al., 2003; Kapp et al., 2007; Mauelshagen et al., 2009; Ngoc et al., 2011; Sonalkar et al., 2017; Wildschut et al., 2011).
In a systematic review of the effectiveness and side effects of different induction abortion medication regimens, the Cochrane Collaboration identified 36 RCTs that used various agents and methods of administration. The researchers concluded that a combination of mifepristone and misoprostol
15 See Chapter 3 for a review of factors contributing to the dearth of trained providers.
16 Both states allow exceptions in cases of life endangerment or severe physical health risk to the woman.
is the most effective approach and requires the shortest amount of time (Wildschut et al., 2011).
Guidelines developed by the American College of Obstetricians and Gynecologists (ACOG) and endorsed by the Society of Family Planning (SFP) and the Society of Maternal-Fetal Medicine recommend an alternative misoprostol regimen when mifepristone is not available (ACOG, 2013). Although effective, misoprostol-only regimens take longer (Wildschut et al., 2011) and as a result, are likely to be more costly to the patient with respect to time, discomfort, and out-of-pocket expense.
The National Abortion Federation (NAF) guidelines note that, when performed by trained clinicians, induction abortions can be provided in medical offices, clinics, or higher-level health care facilities (NAF, 2017a).
The expected side effects of induction abortions are similar to those described above for medication abortions at or before 10 weeks’ gestation: cramping, pain, and bleeding, as well as nausea, vomiting, diarrhea, chills, and headache (Borgatta, 2011; Ngoc et al., 2011; Wildschut et al., 2011). The side effects are a result of the medications that are used for induction, the abortion process itself, or the medications used to manage pain (Borgatta, 2011).
The literature on complications resulting from induction abortions is limited by a variety of factors. The available research is a mix of study designs analyzing a variety of treatment protocols and patient populations that differ in important ways, including weeks’ gestation, parity, fetal anomaly, and the pharmaceutical regimens and agents used to induce labor (Goyal, 2009; SFP, 2011a). All of these factors may affect patient outcomes. Moreover, while the research on the outcomes of medication and aspiration abortions draws on the outcomes of thousands of patients, the study samples for research on inductions are relatively small and thus have limited statistical power. Nevertheless, the available evidence consistently finds that induction abortion rarely leads to serious complications, although they occur more often than in D&E procedures (Bryant et al., 2011; Grossman, et al., 2008; Mauelshagen et al., 2009; SFP, 2011b).
In addition, among women with a prior cesarean delivery, the use of prostaglandins (particularly misoprostol) to induce labor during a normal vaginal delivery has been associated with an increased risk of uterine rupture—a potentially life-threatening condition (Lydon-Rochelle et al., 2001). Because methods to induce abortion are similar to those used to induce vaginal deliveries, research has assessed whether women with a prior cesarean are at similar risk of uterine rupture when undergoing an induction abortion. The evidence suggests that misoprostol-induced abortions are safe after a cesarean. Uterine rupture has been documented in fewer than
0.4 percent of induction abortions among women with a prior cesarean (Berghella et al., 2009; Goyal, 2009).
Clinical guidelines suggest that, regardless of abortion method, routine in-person follow-up care is not necessary. However, clinicians may choose to offer an in-person follow-up visit to women 7–14 days after the procedure to confirm the absence of ongoing pregnancy and to assess recovery (NAF, 2017a; WHO, 2014). In the case of medication abortion, which usually occurs in a nonclinical setting, confirmation of termination of the pregnancy is the primary concern after the abortion. The FDA advises that follow-up is needed to confirm complete termination of pregnancy, but that termination can be confirmed by medical history, clinical examination, hCG testing, or ultrasound (FDA, 2016a). Similarly, NAF advises that confirmation can be established by any of these methods in an office, by telephone, or through electronic communication (NAF, 2017a).
Before a woman leaves a facility after an abortion procedure (or after she has taken the appropriate medication in the case of medication abortion), she should receive instructions on what to expect after the procedure, self-care, resuming intercourse, recognizing signs and symptoms of complications, and how and where to seek assistance if needed (NAF, 2017a; RCOG, 2015; WHO, 2014). Fertility goals and future pregnancy should be discussed, and if a woman opts for contraceptive counseling or a method of contraception, it should be provided before she leaves the facility (NAF, 2017a; RCOG, 2016; WHO, 2014). Other treatment (pain medication, medication for RhD-negative patients, emotional support) and referrals for other services (STI/HIV counseling and testing, abuse support services, psychological or social services, and services of other physician specialists) should also be provided before discharge, as needed (RCOG, 2016; WHO, 2014).
As with any other procedure, women who receive minimal, moderate, or deeper sedation should be monitored continuously during a recovery period until they have been evaluated and determined to be no longer at risk for hemodynamic instability or respiratory depression (NAF, 2017a). Prior to discharge, women must be ambulatory with stable blood pressure and pulse, bleeding and pain must be controlled, and these criteria must be documented (NAF, 2017a).
USE OF ANALGESIA, SEDATION, AND ANESTHESIA IN ABORTION CARE
Patient comfort not only is of critical interest to the patient but also affects the ability of the clinician to perform a procedure safely and
effectively (Allen et al., 2013). People differ in their experience of and tolerance for pain. In their review of pain relief for obstetrical and gynecological procedures in outpatient settings, Allen and colleagues (2013) observed that anxiety, depression, and a woman’s expectation of pain are strong predictors of her actual experience of pain during a procedure.
NAF recommends that providers involve women in the analgesia/sedation/anesthesia decision and that the choice be based on the individual patient’s needs and an assessment of the risks and benefits (NAF, 2017a). The pain management approach that is best for women undergoing medication, aspiration, D&E, or induction abortions depends not only on which method is used but also on weeks’ gestation, the patient’s preferences for pain control, her comorbidities (if any), the availability of equipment and specialized personnel, provider preferences, cost, and facility licensure (Allen et al., 2012, 2013; NAF, 2017a; Nichols et al., 2009; RCOG, 2015). Results of a 2002 survey of NAF administrators and providers offer some insight into providers’ preferred methods for pain control during aspiration abortions. Almost half (46 percent) of the 110 survey respondents preferred using local and/or oral medication, 33 percent preferred local plus IV sedation, and 21 percent preferred deep sedation or general anesthesia (O’Connell et al., 2009). The survey also elicited information regarding pain control for D&E and induction abortions. Most clinics that offered combined local and IV conscious sedation or general anesthesia used these methods for more than 80 percent of their patients (O’Connell et al., 2008).
The literature on the effectiveness of nonpharmacological approaches to reducing pain during abortion is inconclusive (Tschann et al., 2016). While a variety of methods have been assessed, including relaxation techniques (e.g., focused breathing, visualization, vocal coaching, and positive suggestion), hypnosis, aromatherapy, and abortion doulas, more definitive research is needed.
Pain Management During Aspiration, D&E, and Induction Abortions
The pharmaceutical options for pain management during an abortion range from oral analgesics (e.g., NSAIDs), to local anesthesia (typically a paracervical block), to minimal sedation/anxiolysis, to moderate sedation/analgesia, to deep sedation/analgesia, to general anesthesia (NAF, 2017a). Along this continuum, the physiological effects of sedation have increasing clinical implications and, depending on the depth of sedation, may require special equipment and personnel to ensure the patient’s safety (see Tables 2-2 and 2-3). The greatest risk of using sedative agents is respiratory depression.
The American Society of Anesthesiologists (ASA) issues clinical standards for the safe use of pain medications and anesthesia in the types
TABLE 2-2 Levels and Effects of Analgesia, Sedation, and Anesthesia
|Effect on||Minimal Sedation/Anxiolysisa||Moderate Sedation/Analgesiab||Deep Sedation/Analgesia||General Anesthesia|
|Responsiveness||Normal response to verbal stimulation||Purposeful response to verbal or tactile stimulation||Purposeful response with repeated or painful stimulation||Unarousable by painful stimulus|
|Airway||Unaffected||No intervention required||Intervention may be required||Intervention often required|
|Spontaneous ventilation||Unaffected||Adequate||May be inadequate||Frequently inadequate|
|Cardiovascular function||Unaffected||Usually maintained||Usually maintained||May be impaired|
a Minimal sedation includes local anesthesia, e.g., in the form of a paracervical block.
b Moderate sedation is sometimes described as “conscious sedation.”
SOURCES: ASA, 2015; ASA Task Force, 2002.
of outpatient clinical settings where abortions are provided (ASA, 2013, 2014b, 2015). The standards use a physical health classification system—ASA I through ASA VI—to guide clinicians’ decisions about anesthesia options. ASA I patients are healthy, and ASA II patients have mild systemic disease;17 both are medically eligible for all options up to deep sedation in office-based settings. The vast majority of abortion patients—young women—are in these categories. Women with severe systemic disease (ASA III and IV) require further medical assessment and may be eligible for deep sedation (monitored anesthesia care [MAC]) or general anesthesia in an accredited ambulatory surgery center (ASC) or hospital. Table 2-2 shows the ASA levels of sedation and their effects on cognitive, respiratory, and cardiovascular function.
Safeguards for Managing Complications and Emergencies During an Abortion
The key safeguards—for abortions and all outpatient procedures—are whether the facility has the appropriate equipment, personnel, and
17 ASA II patients (mild systemic disease) have no functional limitations and well-controlled disease, such as controlled hypertension or diabetes (without systemic effects), mild lung disease, or mild obesity (BMI between 30 and 40) (ASA, 2014a).
TABLE 2-3 Minimum Facility Requirements Related to Level of Sedation for Medication, Aspiration, and Dilation and Evacuation (D&E) Abortions
|Abortion Method||Minimum Facility Requirementsa|
|Equipment to Monitor Oxygen Saturation, Heart Rate, and Blood Pressure||Equipment to Monitor Ventilation (e.g., end-tidal carbon dioxide)b||Emergency Resuscitation Equipment||Emergency Transfer Plan|
|Aspiration with moderate sedationa D&E||—|
|Deep sedation, or monitored anesthesia care (MAC)|
NOTES: Checkmarks denote American Society of Anesthesiologists (ASA) minimal facility requirements as they relate to the level of sedation used in medication, aspiration, and D&E abortions.
a These requirements are for healthy patients or patients with mild systemic disease, i.e., ASA physical health status classifications ASA I and ASA II. Women with severe systemic disease (i.e., ASA III and IV) should be evaluated, and consideration should be given to using deep sedation (MAC) or general anesthesia in an accredited facility such as an ambulatory surgery center or hospital.
b End-tidal carbon dioxide monitoring refers to the noninvasive measurement of exhaled carbon dioxide.
SOURCES: Allen et al., 2013; ASA, 2013, 2014a,b, 2015; ASA Task Force, 2002.
emergency transfer plan to address any complications that might occur. While data on the use of specific pain management methods during an abortion are very limited, studies that report outcomes for patients after an abortion find that current pain management methods are safe when appropriate precautions are followed (Dean et al., 2011; Gokhale et al., 2016; Renner et al., 2012).
Table 2-3 shows the ASA minimal facility requirements as they relate to the level of sedation used in medication, aspiration, and D&E abortions. No special equipment or emergency arrangements are required for medication abortions. If moderate sedation is used during an aspiration
abortion, the facility should have emergency resuscitation equipment and an emergency transfer plan, as well as equipment to monitor oxygen saturation, heart rate, and blood pressure. D&Es that involve deep sedation or general anesthesia should be provided in similarly equipped facilities that also have equipment to monitor ventilation (e.g., end-tidal carbon dioxide) (ASA Task Force, 2002).
New insights into the safe provision of sedation and anesthesia for abortions in outpatient settings are forthcoming. A unique research project, currently ongoing, is comparing the relative safety, cost, and complications of providing abortions in office-based settings and ASCs (ANSIRH, 2017; Roberts, 2017). The investigators are using a national private insurance claims database containing approximately 50 million patient records to compare adverse events, including anesthesia-related outcomes, in the two settings. The study’s results were not available when the committee prepared this report. However, analyses of large-scale databases suggest that the risk of hospital admission after outpatient surgery (involving deep sedation) is rare for healthy patients undergoing procedures that last less than 120 minutes (Fleisher et al., 2007). As noted earlier, aspiration abortions typically take 10 minutes, and D&E procedures less than 30 minutes.
The use of sedation and anesthesia also has important implications for personnel. If moderate sedation is used, it is essential to have a nurse or other qualified clinical staff—in addition to the person performing the abortion—available to monitor the patient (ASA Task Force, 2002; NAF, 2017a). Both deep sedation and general anesthesia require the expertise of an anesthesiologist or certified registered nurse anesthetist (CRNA) to ensure patient safety.
Evidence on Complications of Analgesia, Sedation, and Anesthesia During Abortions
This section reviews the available evidence on complications related to pain management during aspiration, D&E, and induction abortions. As noted above, NSAIDs reduce the discomfort of pain and cramping safely and effectively during a medication abortion.
Aspiration Pain Management
Paracervical blocks are used routinely to reduce the pain of cervical dilation during aspiration procedures (Allen et al., 2013; Nichols et al., 2009). Moderate and deep sedation are also options for aspiration
abortion. The blocks are effective in decreasing pain related to cervical dilation and uterine aspiration, although administration of the block itself is painful (Allen et al., 2013; Renner et al., 2012), and some providers use other medications to reduce the pain of the injection (Allen et al., 2013). Because some women report experiencing moderate to significant procedural pain even with the block, researchers are trying to identify an optimal approach to pain management without sedation during aspiration (Allen et al., 2013; O’Connell et al., 2009; Renner et al., 2012, 2016).
Adverse events related to the use of local anesthesia, regardless of the clinical circumstances, are rare (Nichols et al., 2009). In a recent retrospective cohort study, Horwitz and colleagues (2018) used electronic medical record data to assess whether obesity increased the risk of anesthesia-related complications18 after an aspiration abortion with moderate IV sedation. The study, based in several Massachusetts outpatient clinics, included 20,381 women. Complications were rare and not associated with BMI19 (Horwitz et al., 2018).
The White and colleagues (2015) systematic review described above identified 11 studies that report patient outcomes related to the use of local anesthesia, moderate sedation, or general anesthesia for aspiration abortions. Anesthesia-related complications were rare regardless of the clinical setting or level of sedation: ≤0.2 percent of office-based procedures and ≤0.5 percent of procedures in surgical centers and hospital-based clinics.
D&E Pain Management
A typical D&E regimen includes a paracervical block supplemented with either moderate sedation (using benzodiazepines and/or opiates) or deep sedation with propofol (without intubation) (NAF, 2017a; RCOG, 2015; WHO, 2012, 2014). In office settings, deep sedation should be used only for healthy patients (ASA I) or patients with mild systemic disease (ASA II), and strict fasting guidelines should be followed before the procedure (ASA Task Force, 2002).
Two large-scale, retrospective analyses have demonstrated the safety of using deep sedation for aspiration and D&E abortions in clinic settings (Dean et al., 2011; Gokhale et al., 2016). Dean and colleagues (2011) assessed the experience of 62,125 women who had an aspiration or D&E abortion (up to 24 weeks’ gestation) using deep sedation with propofol
18 The primary outcome assessed was supplemental oxygen administration. Secondary outcomes included reversal agent administration, anesthesia-related adverse events, and intraoperative lowest level of consciousness.
19 Obesity groups (BMI = 30–34.9; BMI = 35–39.9; BMI ≥40) were compared with women with BMI <25.
(without intubation) in a high-volume licensed clinic in New York State between 2001 and 2008.20 Deep sedation was provided only to medically eligible patients who followed strict fasting guidelines. The procedures were monitored by an anesthesiologist or CRNA. The researchers reviewed the medical records of all women who were transferred to a hospital (n = 26) because of complications and found that no hospital transfers occurred because of an anesthesia complication.
In a more recent study, Gokhale and colleagues (2016) assessed the outcomes for 5,579 aspiration and D&E abortions using IV sedation (without intubation) at a freestanding abortion clinic in Cleveland from 2012 to 2013. Patients were screened for medical eligibility and followed fasting guidelines. Sedation was administered by registered nurses or by CRNAs if propofol was administered. There were no hospital transfers for anesthesia-related indications. Naloxone was required for opioid reversal in 0.2 percent of patients. The study also compared outcomes for obese and nonobese women; no differences were found.
Induction Pain Management
There is little research on how best to manage pain during an induction (Jackson and Kapp, 2011). Comparisons of different analgesic regimens are not available, and the optimal approach to effective treatment of pain is not well established (Wiebe and Renner, 2014). The options will depend on the provider’s resources and the particular clinical circumstances. Nulliparous women may require more analgesia compared with multiparous women (Ashok et al., 2004). The levels of pain in later-gestation induction abortions are said to be similar to those in normal delivery, but the committee found no studies documenting this (Smith et al., 2016; Viviand et al., 2003).
Death associated with a legal abortion in the United States is an exceedingly rare event. As Table 2-4 shows, the risk of death subsequent to a legal abortion21 (0.7 per 100,000) is a small fraction of that for childbirth (8.8 per 100,000) (Bartlett et al., 2004; Zane et al., 2015).22 Abortion-related
20 One patient received an endotracheal intubation.
21 The CDC defines an abortion-related death as “a death resulting from a direct complication of an induced abortion, an indirect complication caused by a chain of events initiated by an abortion procedure, or the aggravation of a pre-existing condition by the physiologic or psychological effects of the abortion” (Jatlaoui et al., 2016, p. 4).
22 The CDC calculates the rate of abortion mortality using deaths reported to the CDC Abortion Surveillance System and dividing them by the estimated number of abortion procedures in the United States (CDC, 2017; Jones and Jerman, 2014).
TABLE 2-4 Comparison of Mortality Rates for Abortion, Childbirth, Colonoscopy, Dental Procedures, Plastic Surgery, and Tonsillectomy, United States
|Procedure (Study Period)||Mortality Rate (number of deaths per 100,000 procedures)|
|Abortion (legal) (1988–2010)||0.7|
|Dental procedures (1999–2005)||0.0 to 1.7|
|Plastic surgery (2000–2012)||0.8 to 1.7|
|Tonsillectomy (1968–1972)||2.9 to 6.3|
NOTE: Reported tonsillectomy rates were recalculated to reflect the rate per 100,000 procedures.
SOURCES: Baugh et al., 2011; Raymond and Grimes, 2012; Raymond et al., 2014; Reumkens et al., 2016; Zane et al., 2015.
mortality is also lower than that for colonoscopies (2.9 per 100,000), plastic surgery (0.8 to 1.7 per 100,000), dental procedures (0.0 to 1.7 per 100,000), and adult tonsillectomies (2.9 to 6.3 per 100,000). Comparable data for other common medical procedures are difficult to find.
The CDC monitors abortion-related deaths through its Pregnancy Mortality Surveillance System (Jatlaoui et al., 2017). The surveillance data underscore the increased risk of having an abortion later in pregnancy. Zane and colleagues (2015) assessed differences in abortion-related mortality by race, maternal age, and weeks’ gestation using data from the CDC surveillance system. Among the 16.1 million legal abortions performed from 1998 to 2010, there were 108 deaths (0.7 per 100,000). Twenty deaths occurred among high-risk women whose pregnancy was life threatening. Infection and anesthesia complications were the most frequent cause of death for procedures performed up to 13 weeks’ gestation. After 13 weeks, the deaths reported were due primarily to infection or hemorrhage.
The researchers found that weeks’ gestation was the strongest predictor of abortion-related mortality. At 8 weeks’ gestation or less, the death rate was 0.3 per 100,000; after 17 weeks, the rate was 6.7 per 100,000. Death rates were approximately three times as high for black women as for white women—similar to the disparities found in pregnancy outcomes overall (Creanga et al., 2012, 2015, 2017; MacDorman et al., 2017). From 2011 to 2013, for example, the overall maternal mortality ratio for non-Hispanic black women was 3.4 times higher than that for non-Hispanic white women (Creanga et al., 2017). A study of maternal mortality in 2013 to 2014 found a 22 percent lower (p = .02) mortality rate for Hispanic women compared with non-Hispanic white women; in 2008–2009, the
mortality rate for Hispanic women was similar to that for non-Hispanic white women, but the difference was attributed to the 28 percent increase (p <.001) in mortality for non-Hispanic white women (MacDorman et al., 2017). MacDorman and colleagues (2017) note that almost all of the increase in maternal mortality was among woman aged 40 and older and for nonspecific causes of death.
STATE REGULATION OF ABORTION CARE
States play an essential role in ensuring the safety of health care services, especially through their licensure of clinicians and health care facilities. In every state, clinicians and inpatient facilities (e.g., hospitals, rehabilitation centers) must be licensed by a state board or agency to provide health care services legally (Chaudhry et al., 2013). State licensure may require the facility to be accredited by an independent accrediting organization. Regardless, Medicare and Medicaid, as well as private insurers, require accreditation for inpatient facilities and ASCs to be eligible for reimbursement (CMS, 2012). ASCs provide surgical services to patients not requiring hospitalization when the expected duration of services does not exceed 24 hours (CMS, 2016). In most states, ASCs must also be licensed to provide outpatient surgery, and in many states, ASCs must be accredited (ACFAS, 2017).23
Unlike other health care procedures provided in office-based settings, abortions are subject to a wide array of regulations that vary by state. Except for abortion, states typically regulate individual, office-based health services only when the service involves using sedation or general anesthesia (and depending on the level of sedation) (Jones, 2017). Twenty-five states regulate office-based procedures (other than abortion). In 23 of these states,24 the regulation is triggered by the level of sedation, and in most cases, it requires that the facility be either accredited or licensed by the state in order to offer patients moderate or deep sedation (Jones, 2017; Jones et al., 2018).25
State abortion regulations often have a direct impact on the delivery of abortion care. They may stipulate the type of clinician that is allowed to perform an abortion independently of the relevant scope of practice laws
23 According to the American College of Foot and Ankle Surgeons, 46 states require ASCs to be licensed, and 28 states (including the District of Columbia) require accreditation (ACFAS, 2017).
24 The 23 states are Alabama, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Indiana, Kansas, Louisiana, Mississippi, Nevada, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, and Washington.
25 Personal communication, B. S. Jones, Advancing New Standards in Reproductive Health (ANSIRH), July 3, 2017.
(e.g., qualified advanced practice clinicians [APCs] or physicians without hospital privileges may be barred from performing abortions); how the informed consent process is conducted (e.g., providers may be required to misrepresent the risks of the procedure); the abortion method that is used (e.g., D&Es may be banned); the timing and scheduling of procedures (e.g., women may have to wait 18 to 72 hours after a counseling appointment); the physical attributes of the clinical setting (e.g., procedure room size, corridor width); and other basic elements of care. In most states, the regulations apply to all abortion methods regardless of weeks’ gestation, use of sedation, or the invasiveness of the procedure.
See Table 1-1 in Chapter 1 for a listing of abortion-specific regulations by states as of September 1, 2017.
The clinical evidence presented in this chapter on the provision of safe and high-quality abortion care stands in contrast to the extensive regulatory requirements that state laws impose on the provision of abortion services. These requirements may influence the efficiency of abortion care by requiring medically unnecessary services and multiple visits to the abortion facility, in addition to requiring that care take place in costlier and more sophisticated settings than are clinically necessary. These requirements go beyond the accepted standards of care in the absence of evidence that they improve safety. Some requirements, such as multiple visits and waiting periods, delay abortion services, and by doing so may increase the clinical risks and cost of care. They may also limit women’s options for care and impact providers’ ability to provide patient-centered care. Furthermore, many of these laws have been documented to reduce the availability of care by imposing unneeded regulations on abortion providers and the settings in which abortion services are delivered. The implications of abortion-specific regulations for the safety and quality of abortion care are described below.
Delaying the Procedure
The clinical evidence makes clear that legal abortions in the United States—whether by medication, aspiration, D&E, or induction—are safe and effective. Serious complications are rare; in the vast majority of studies, they occur in fewer than 1 percent of abortions, and they do not exceed 5 percent in any of the studies the committee identified. However, the risk of a serious complication increases with weeks’ gestation. As the number of weeks increases, the invasiveness of the required procedure and the need for
deeper levels of sedation also increase. Thus, delaying the abortion increases the risk of harm to the woman.
State regulations that require women to make multiple in-person visits and wait multiple days delay the abortion. If the waiting period is required after an in-person counseling appointment, the delay is exacerbated (Roberts et al., 2016; Sanders et al., 2016; White et al., 2017). Restrictions on the types of providers and on the settings in which abortion services can be provided also delay care by reducing the availability of care (Baum et al., 2016; Fuentes et al., 2016; Gerdts et al., 2016; Grossman et al., 2014, 2017).
Financial burdens and difficulty obtaining insurance are frequently cited by women as reasons for delay in obtaining an abortion (Bessett et al., 2011; Drey et al., 2006; Finer et al. 2006; Foster and Kimport, 2013; Foster et al., 2008; French et al., 2016; Janiak et al., 2014; Kiley et al., 2010; Roberts et al., 2014; Upadhyay et al., 2014). As noted in Chapter 1, 33 states prohibit public payers from paying for abortions, and other states have laws that either prohibit health insurance exchange plans (25 states) or private insurance plans (11 states) sold in the state from covering or paying for abortions, with few exceptions.26
Counseling and Informed Consent
Long-established ethical and legal standards for informed consent in health care appear to have been compromised in the delivery of abortion care in many areas of the country. Thirty-five states have abortion-specific regulations requiring women to receive counseling before an abortion is performed, and abortion patients in many of these states are offered or given inaccurate or misleading information (verbally or in writing) on reversing medication abortions, risks to future fertility, possible breast cancer risk, and/or long-term mental health consequences of abortion (Guttmacher Institute, 2017a) (see Table 1-1 in Chapter 1). As noted earlier in this chapter, the principal objective of the informed consent process is that patients understand the nature and risks of the procedure they are considering (AAAHC, 2016; AMA, 2016; HHS, 2017a; Joint Commission, 2016). However, legally requiring providers to inform women about risks that are not supported and are even invalidated by scientific research violates the accepted standards of informed consent. For example, some states require that providers inform women that abortion puts them at greater risk for breast cancer; mental health disorders; and difficulties in having a healthy, successful pregnancy
26 Exceptions are limited and vary by state. They are often made for pregnancies resulting from rape or incest, pregnancies that endanger the woman’s life or severely threaten the health of the woman, and cases of fetal impairment.
(Guttmacher Institute, 2017a) (see Table 1-1 in Chapter 1 for a detailed list of states’ informed consent requirements). Three states require providers to inform women that a medication abortion can be reversed after the woman takes mifepristone (Guttmacher Institute, 2017a). This information is not supported by research that meets scientific standards. See Chapter 4 for an in-depth review of the long-term health effects of abortion.
There is no evidence that the dispensing or taking of mifepristone tablets requires the physical presence of a clinician27 or a facility with the attributes of an ASC or hospital to ensure safety or quality. The effects of mifepristone occur after women leave the clinic, and extensive research shows that serious complications are rare. The risks of medication abortion are similar in magnitude to the risks of taking commonly prescribed and over-the-counter medications such as antibiotics and NSAIDs. In 35 states, however, only physicians are permitted to give women the mifepristone tablet(s) required to begin the process of medication abortion (RHN, 2017). In 19 states, the clinician (a physician or other provider if allowed) must be physically present to provide the medication, thus prohibiting the use of telemedicine to prescribe the medication remotely for abortion (Guttmacher Institute, 2017b). In 17 states, medication abortions must be performed in a facility that meets the structural standards of ASCs even though the abortion will occur outside the clinical setting, and there is no evidence to suggest that these regulations improve safety or quality.
Aspirations are minimally invasive and commonly used for a variety of purposes in gynecology practices, including for early pregnancy loss (miscarriage). Aspiration abortions are performed safely in office-based settings and can be provided by appropriately trained APCs, as well as family practice physicians and OB/GYNs. If moderate sedation is used, the procedure should be performed in a facility that meets the relevant ASA facility standards. There is no evidence that performing aspiration abortions in ASCs increases the safety or efficacy of the procedure. The state regulations described above also affect aspiration abortion procedures: 44 states do not allow APCs to perform aspirations, and 16 states mandate that the procedure be performed in an ASC-like facility.
27Chapter 3 reviews the clinical competencies needed to provide safe and high-quality abortions, as well as state regulations regarding the role of APCs.
D&E and Induction Abortions
D&E is usually the medically preferred method for abortions at 14 weeks’ gestation or later. The alternative—induction—is more painful, slower, and more expensive. D&Es are banned in Mississippi28 and West Virginia29 except if the woman’s physical health or life is severely threatened.
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