This report provides a comprehensive review of the state of the science on the safety and quality of abortion services in the United States. The committee was charged with answering eight specific research questions. This chapter presents the committee’s conclusions by responding individually to each question. The research findings that are the basis for these conclusions are presented in the previous chapters. The committee was also asked to offer recommendations regarding the eight questions. However, the committee decided that its conclusions regarding the safety and quality of U.S. abortion care responded comprehensively to the scope of this study. Therefore, the committee does not offer recommendations for specific actions to be taken by policy makers, health care providers, and others.
1. What types of legal abortion services are available in the United States? What is the evidence regarding which services are appropriate under different clinical circumstances (e.g., based on patient medical conditions such as previous cesarean section, obesity, gestational age)?
Four legal abortion methods—medication,1 aspiration, dilation and evacuation (D&E), and induction—are used in the United States. Length of gestation—measured as the amount of time since the first day of the last
1 The terms “medication abortion” and “medical abortion” are used interchangeably in the literature. This report uses “medication abortion” to describe the U.S. Food and Drug Administration (FDA)-approved prescription drug regimen used up to 10 weeks’ gestation.
menstrual period—is the primary factor in deciding what abortion procedure is the most appropriate. Both medication and aspiration abortions are used up to 10 weeks’ gestation. Aspiration procedures may be used up to 14 to 16 weeks’ gestation.
Mifepristone, sold under the brand name Mifeprex, is the only medication specifically approved by the FDA for use in medication abortion. The drug’s distribution has been restricted under the requirements of the FDA Risk Evaluation and Mitigation Strategy program since 2011—it may be dispensed only to patients in clinics, hospitals, or medical offices under the supervision of a certified prescriber. To become a certified prescriber, eligible clinicians must register with the drug’s distributor, Danco Laboratories, and meet certain requirements. Retail pharmacies are prohibited from distributing the drug.
When abortion by aspiration is no longer feasible, D&E and induction methods are used. D&E is the superior method; in comparison, inductions are more painful for women, take significantly more time, and are more costly. However, D&Es are not always available to women. The procedure is illegal in Mississippi2 and West Virginia3 (both states allow exceptions in cases of life endangerment or severe physical health risk to the woman). Elsewhere, access to the procedure is limited because many obstetrician/gynecologists (OB/GYNs) and other physicians lack the requisite training to perform D&Es. Physicians’ access to D&E training is very limited or nonexistent in many areas of the country.
Few women are medically ineligible for abortion. There are, however, specific contraindications to using mifepristone for a medication abortion or induction. The drug should not be used for women with confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass; an intrauterine device in place; chronic adrenal failure; concurrent long-term systemic corticosteroid therapy; hemorrhagic disorders or concurrent anticoagulant therapy; allergy to mifepristone, misoprostol, or other prostaglandins; or inherited porphyrias.
Obesity is not a risk factor for women who undergo medication or aspiration abortions (including with the use of moderate intravenous sedation). Research on the association between obesity and complications during a D&E abortion is less certain—particularly for women with Class III obesity (body mass index ≥40) after 14 weeks’ gestation.
A history of a prior cesarean delivery is not a risk factor for women undergoing medication or aspiration abortions, but it may be associated
2 Mississippi Unborn Child Protection from Dismemberment Abortion Act, Mississippi HB 519, Reg. Sess. 2015–2016 (2016).
3 Unborn Child Protection from Dismemberment Abortion Act, West Virginia SB 10, Reg. Sess. 2015–2016 (2016).
with an increased risk of complications during D&E abortions, particularly for women with multiple cesarean deliveries. Because induction abortions are so rare, it is difficult to determine definitively whether a prior cesarean delivery increases the risk of complications. The available research suggests no association.
2. What is the evidence on the physical and mental health risks of these different abortion interventions?
Abortion has been investigated for its potential long-term effects on future childbearing and pregnancy outcomes, risk of breast cancer, mental health disorders, and premature death. The committee found that much of the published literature on these topics does not meet scientific standards for rigorous, unbiased research. Reliable research uses documented records of a prior abortion, analyzes comparable study and control groups, and controls for confounding variables shown to affect the outcome of interest.
Physical health effects The committee identified high-quality research on numerous outcomes of interest and concludes that having an abortion does not increase a woman’s risk of secondary infertility, pregnancy-related hypertensive disorders, abnormal placentation (after a D&E abortion), preterm birth, or breast cancer. Although rare, the risk of very preterm birth (<28 weeks’ gestation) in a woman’s first birth was found to be associated with having two or more prior aspiration abortions compared with first births among women with no abortion history; the risk appears to be associated with the number of prior abortions. Preterm birth is associated with pregnancy spacing after an abortion: it is more likely if the interval between abortion and conception is less than 6 months (this is also true of pregnancy spacing in general). The committee did not find well-designed research on abortion’s association with future ectopic pregnancy, miscarriage or stillbirth, or long-term mortality. Findings on hemorrhage during a subsequent pregnancy are inconclusive.
Mental health effects The committee identified a wide array of research on whether abortion increases women’s risk of depression, anxiety, and/or posttraumatic stress disorder and concludes that having an abortion does not increase a woman’s risk of these mental health disorders.
3. What is the evidence on the safety and quality of medical and surgical abortion care?
Safety The clinical evidence clearly shows that legal abortions in the United States—whether by medication, aspiration, D&E, or induction—are
safe and effective. Serious complications are rare. But 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.
Quality Health care quality is a multidimensional concept. Six attributes of health care quality—safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity—were central to the committee’s review of the quality of abortion care. Table 5-1 details the committee’s conclusions regarding each of these quality attributes. Overall, the committee concludes that the quality of abortion care depends to a great extent on where women live. In many parts of the country, state regulations have created barriers to optimizing each dimension of quality care. The quality of care is optimal when the care is based on current evidence and when trained clinicians are available to provide abortion services.
4. What is the evidence on the minimum characteristics of clinical facilities necessary to effectively and safely provide the different types of abortion interventions?
Most abortions can be provided safely in office-based settings. No special equipment or emergency arrangements are required for medication abortions. For other abortion methods, the minimum facility characteristics depend on the level of sedation that is used. Aspiration abortions are performed safely in office and clinic settings. If moderate sedation is used, 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. For D&Es that involve deep sedation or general anesthesia, the facility should be similarly equipped and also have equipment to provide general anesthesia and monitor ventilation.
Women with severe systemic disease require special measures if they desire or need deep sedation or general anesthesia. These women require further clinical assessment and should have their abortion in an accredited ambulatory surgery center or hospital.
5. What is the evidence on what clinical skills are necessary for health care providers to safely perform the various components of abortion care, including pregnancy determination, counseling, gestational age assessment, medication dispensing, procedure performance, patient monitoring, and follow-up assessment and care?
Required skills All abortion procedures require competent providers skilled in patient preparation (education, counseling, and informed consent);
|Quality Attributea||Definition||Committee’s Conclusions|
|Safety||Avoiding injuries to patients from the care that is intended to help them.||Legal abortions—whether by medication, aspiration, D&E, or induction—are safe. Serious complications are rare and occur far less frequently than during childbirth. Safety is enhanced when the abortion is performed as early in pregnancy as possible.|
|Effectivenessb||Providing services based on scientific knowledge to all who could benefit and refraining from providing services to those not likely to benefit (avoiding underuse and overuse, respectively).||
Legal abortions—whether by medication, aspiration, D&E, or induction—are effective. The likelihood that women will receive the type of abortion services that best meets their needs varies considerably depending on where they live. In many parts of the country, abortion-specific regulations on the site and nature of care, provider type, provider training, and public funding diminish this dimension of quality care. The regulations may limit the number of available providers, misinform women of the risks of the procedures they are considering, overrule women’s and clinician’s medical decision making, or require medically unnecessary services and delays in care. These include policies that
|Quality Attributea||Definition||Committee’s Conclusions|
|Patient-Centeredness||Providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions.||
Patients’ personal circumstances and individual preferences (including preferred abortion method), needs, and values may be disregarded depending on where they live (as noted above). The high state-to-state variability regarding the specifics of abortion care may be difficult for patients to understand and navigate. Patients’ ability to be adequately informed in order to make sound medical decisions is impeded when state regulations require that
|Timeliness||Reducing waits and sometimes harmful delays for both those who receive and those who give care.||
The timeliness of an abortion depends on a variety of local factors, such as the availability of care, affordability, distance from the provider, and state requirements for an in-person counseling appointment and waiting periods (18 to 72 hours) between counseling and the abortion.
|Efficiency||Avoiding waste, including waste of equipment, supplies, ideas, and energy.||An extensive body of clinical research has led to important refinements and improvements in the procedures, techniques, and methods for performing abortions. The extent to which abortion care is delivered efficiently depends, in part, on the alignment of state regulations with current evidence on best practices. Regulations that require medically unnecessary equipment, services, and/or additional patient visits increase cost, and thus decrease efficiency.|
|Quality Attributea||Definition||Committee’s Conclusions|
|Equity||Providing care that does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status.||
State-level abortion regulations are likely to affect women differently based on their geographic location and socioeconomic status. Barriers (lack of insurance coverage, waiting periods, limits on qualified providers, and requirements for multiple appointments) are more burdensome for women who reside far from providers and/or have limited resources.
a These attributes of quality health care were first proposed by the Institute of Medicine’s Committee on Quality of Health Care in America in the 2001 report Crossing the Quality Chasm: A New Health System for the 21st Century.
b Elsewhere in this report, effectiveness refers to the successful completion of the abortion without the need for a follow-up aspiration.
clinical assessment (confirming intrauterine pregnancy, determining gestation, taking a relevant medical history, and physical examination); pain management; identification and management of expected side effects and serious complications; and contraceptive counseling and provision. To provide medication abortions, the clinician should be skilled in all these areas. To provide aspiration abortions, the clinician should also be skilled in the technical aspects of an aspiration procedure. To provide D&E abortions, the clinician needs the relevant surgical expertise and sufficient caseload to maintain the requisite surgical skills. To provide induction abortions, the clinician requires the skills needed for managing labor and delivery.
Clinicians that have the necessary competencies Both trained physicians (OB/GYNs, family medicine physicians, and other physicians) and advanced practice clinicians (APCs) (physician assistants, certified nurse-midwives, and nurse practitioners) can provide medication and aspiration abortions safely and effectively. OB/GYNs, family medicine physicians, and other physicians with appropriate training and experience can perform D&E abortions. Induction abortions can be provided by clinicians (OB/GYNs,
family medicine physicians, and certified nurse-midwives) with training in managing labor and delivery.
The extensive body of research documenting the safety of abortion care in the United States reflects the outcomes of abortions provided by thousands of individual clinicians. The use of sedation and anesthesia may require special expertise. 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, as is the case for any other medical procedure. Deep sedation and general anesthesia require the expertise of an anesthesiologist or certified registered nurse anesthetist to ensure patient safety.
6. What safeguards are necessary to manage medical emergencies arising from abortion interventions?
The key safeguards—for abortions and all outpatient procedures—are whether the facility has the appropriate equipment, personnel, and emergency transfer plan to address any complications that might occur. No special equipment or emergency arrangements are required for medication abortions; however, clinics should provide a 24-hour clinician-staffed telephone line and have a plan to provide emergency care to patients after hours. 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.
The committee found no evidence indicating that clinicians that perform abortions require hospital privileges to ensure a safe outcome for the patient. Providers should, however, be able to provide or arrange for patient access or transfer to medical facilities equipped to provide blood transfusions, surgical intervention, and resuscitation, if necessary.
7. What is the evidence on the safe provision of pain management for abortion care?
Nonsteroidal anti-inflammatory drugs (NSAIDs) are recommended to reduce the discomfort of pain and cramping during a medication abortion. Some women still report high levels of pain, and researchers are exploring new ways to provide prophylactic pain management for medication abortion. The pharmaceutical options for pain management during aspiration, D&E, and induction abortions range from local anesthesia, to minimal sedation/anxiolysis, to moderate sedation/analgesia, to deep sedation/
analgesia, to general anesthesia. 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. The greatest risk of using sedative agents is respiratory depression. The vast majority of abortion patients are healthy and medically eligible for all levels of sedation in office-based settings. As noted above (see Questions 4 and 6), if sedation is used, the facility should be appropriately equipped and staffed.
8. What are the research gaps associated with the provision of safe, high-quality care from pre- to postabortion?
The committee’s overarching task was to assess the safety and quality of abortion care in the United States. As noted in the introduction to this chapter, the committee decided that its findings and conclusions fully respond to this charge. The committee concludes that legal abortions are safe and effective. Safety and quality are optimized when the abortion is performed as early in pregnancy as possible. Quality requires that care be respectful of individual patient preferences, needs, and values so that patient values guide all clinical decisions.
The committee did not identify gaps in research that raise concerns about these conclusions and does not offer recommendations for specific actions to be taken by policy makers, health care providers, and others.
The following are the committee’s observations about questions that merit further investigation.
Limitation of Mifepristone distribution As noted above, mifepristone, sold under the brand name Mifeprex, is the only medication approved by the FDA for use in medication abortion. Extensive clinical research has demonstrated its safety and effectiveness using the FDA-recommended regimen. Furthermore, few women have contraindications to medication abortion. Nevertheless, as noted earlier, the FDA REMS restricts the distribution of mifepristone. Research is needed on how the limited distribution of mifepristone under the REMS process impacts dimensions of quality, including timeliness, patient-centeredness, and equity. In addition, little is known about pharmacist and patient perspectives on pharmacy dispensing of mifepristone and the potential for direct-to-patient models through telemedicine.
Pain management There is insufficient evidence to identify the optimal approach to minimizing the pain women experience during an aspiration procedure without sedation. Paracervical blocks are effective in decreasing procedural pain, but the administration of the block itself is painful, and
even with the block, women report experiencing moderate to significant pain. More research is needed to learn how best to reduce the pain women experience during abortion procedures.
Research on prophylactic pain management for women undergoing medication abortions is also needed. Although NSAIDs reduce the pain of cramping, women still report high levels of pain.
Availability of providers APCs can provide medication and aspiration abortions safely and effectively, but the committee did not find research assessing whether APCs can also be trained to perform D&Es.
Addressing the needs of women of lower income Women who have abortions are disproportionately poor and at risk for interpersonal and other types of violence. Yet little is known about the extent to which they receive needed social and psychological supports when seeking abortion care or how best to meet those needs. More research is needed to assess the need for support services and to define best clinical practice for providing those services.