Diana Taylor, RN, PhD

Ann C. Hwang, MD

It’s 4:30 at the end of a busy Friday after-noon, when you see your last patient, anadd-on in an acute slot. She is a young

woman who appears anxious; you immedi-ately recognize her as one of your regular pri-mary care patients. When you ask her whatyou can help her with today, she tells you in aquiet voice that she thinks she is pregnant.She used a home pregnancy test that morningbecause her period did not begin as expectedlast week. An in-office pregnancy test con-firms the finding.

She tells you that the pregnancy wasunplanned. She is not ready today to make adecision about what she wants to do, but shewants information about her options, includ-ing continuing her pregnancy, adoption, andabortion. She heard from a friend that there isnow an “abortion pill.” If she did decide to

have an abortion, would this be an option forher?

Three years after its approval for use in theU.S., mifepristone is becoming an option forwomen choosing to terminate a pregnancy.Whether they provide abortion services,women’s health care providers need to be ableto answer women’s questions about abortion.Unintended pregnancy is a common problemfaced by women in their reproductive years.Nearly half of all pregnancies are unintended,and approximately 43 percent of Americanwomen are estimated to have had an abortionby the age of 45 (Henshaw, 1998).

Becoming familiar with mifepristone willenable nurses to answer patients’ questionsand concerns and provide abortion-relatedcounseling and care (see Box 1 for addition-al resources).

Mifepristone Basics

Mifepristone, marketed in the U.S. under the trade name

Mifeprex and known commonly by the French name RU-486,

works by blocking the action of progesterone, a hormone that

maintains pregnancy. Mifepristone is used in combination

with the prostaglandin analogue misoprostol, which stimu-

lates uterine contractions.

The approval of mifepristone by the U.S. Food and Drug

Administration (FDA) in September 2000 was based on a reg-

imen developed a decade ago and tested in France and in the

U.S., to terminate pregnancies of up to 49 days (7 weeks) ges-

tation. The FDA-approved regimen uses a 600 mg dose of

mifepristone (3 tablets), followed by a 400 mcg oral dose of

misoprostol two days later.

Newer studies have provided evidence for refining the

medical abortion protocol, leading to the development of the

“evidence-based” regimen used by most U.S. providers. A 200

mg dose of mifepristone (1 tablet) has been found to be as

effective as the 600 mg dose (Ashok, Penney, Flett, & Temple-

ton, 1998). Studies have also shown that misoprostol can be

self-administered by a patient as an 800 mcg vaginal dose.

Using misoprostol vaginally appears to decrease side effects

and increase the rate of complete abortion at gestations of up

to 63 days (Ashok et al., 1998; El-Refaey, Rajasekar, Abdalla,

Calder, & Templeton, 1995; Schaff, Fielding, & Westhoff,

2002). The increased efficacy of vaginal administration of

misoprostol is thought to be due to improved bioavailability.

Table 1 compares the FDA-approved and evidence-based regi-

mens. Use of an approved product for a purpose not included

in its labeling—evidence-based or “off-label” use—is common

and does not violate FDA requirements.

Clinical ConsiderationsPatients undergoing medical abortion can expect to have some

bleeding and cramping. In one U.S. study using the FDA regi-

men, the median duration of bleeding was 13 days (Spitz,

Bardin, Benton, & Robbins, 1998). The heaviest bleeding

occurs when the abortion is actually taking place and may last

one to four hours. Bleeding severe enough to require a blood

transfusion is very rare, occurring in just 13 of the approxi-

mately 80,000 women who used mifepristone in the first 18

months after its approval (Hausknecht, 2003).

Because bleeding problems occur potentially several days

after misoprostol is given, in-office administration is not pro-

tective. Instead, women should be advised to contact the clini-

cian should they experience heavy bleeding.

The cramping that frequently occurs after misoprostol

administration can be managed satisfactorily with acetamino-

phen, ibuprofen, or an oral narcotic agent. Nonsteroidal anti-

inflammatory drugs do not decrease the efficacy of the med-

ical abortion regimen (Creinin & Shulman, 1997). Heating

pads and having the support of a friend or partner during the

first few hours after medication administration can also be

helpful.

The use of mifepristone and misoprostol is associated with

gastrointestinal side effects, such as (Kruse, Poppema, Creinin,

& Paul, 2000):

• nausea (36 to 67 percent)

• vomiting (13 to 34 percent)

• diarrhea (8 to 23 percent)

• headache (13 to 32 percent)

• dizziness (12 to 37 percent)

• fever or chills (4 to 37 percent)

526 AWHONN Lifelines Volume 7 Issue 6

Table 1.

Comparison of Mifepristone Regimens

FDA-approved regimen Evidence-based regimen

Recommended gestational age: < 49 days after LMP < 63 days after LMP

Mifepristone dose: 600 mg 200 mg

Misoprostol dose: 400 mcg orally, administered 800 mcg vaginally, administeredduring second office visit at home

Misoprostol timing: 48 hours after mifepristone 24-72 hours after mifepristone*(Schaff, Fielding, & Westhoff, 2001; Schaff et al., 2000)

Follow-up office visit: Day 14 Day 4 to 8

*the efficacy of regimens in which misoprostol is given at 72 hours was demonstrated in a study that included women with pregnancies of up to56 days gestation only.

Interviews with women who selected medical abortion found

that all had kept up their routine activities between taking

mifepristone and misoprostol but stayed at home to rest the

day they took misoprostol (Elul, Pearlman, Sorhaindo,

Simonds, & Westhoff, 2000).

In U.S. studies of mifepristone-misoprostol regimens,

approximately 2 to 8 percent of women required an aspiration

procedure, to complete their abortion, terminate a continuing

pregnancy or manage bleeding complications (Schaff et al.,

1999; Schaff, Stadalius, Eisinger, & Franks, 1997; Spitz et al.,

1998). Providers of medical abortion must have a plan in place

for vacuum aspiration backup, and abortion completion

should be confirmed at the patient’s follow-up visit.

Although mifepristone is thought not to be teratogenic,

there have been case reports of fetal abnormalities following

misoprostol use (Philip, Shannon, & Winikoff, 2003). Whether

these abnormalities were caused by mifepristone use is not

known, but a woman who has a continuing pregnancy after

medical abortion treatment should be carefully counseled

about the potential risks to the fetus should she decide against

vacuum aspiration to terminate the pregnancy.

Contraindications to mifepristone-misoprostol are

uncommon and include:

• ectopic pregnancy (because mifepristone does not treatectopic pregnancy)

• an IUD in place (the IUD must be removed before themedical abortion is begun)

• adrenal failure• current long-term systemic corticosteroid therapy• a history of allergy to mifepristone, misoprostol or

prostaglandins• a bleeding disorder or treatment with anticoagulation• an uncontrolled seizure disorder• inflammatory bowel disease

Providers should use caution if a woman has severe anemia.

It’s not known whether mifepristone or the misoprostol

metabolite misoprostol acid is excreted in breastmilk. There is

concern that misoprostol acid could cause diarrhea in a nurs-

ing infant, although its half-life is short (20 to 40 minutes with

oral administration). Breastfeeding mothers might consider

discarding their breastmilk for the time surrounding the med-

ical abortion.

Patients who choose medical abortion report a high degree

of satisfaction with the method: 85 to 96 percent would rec-

ommend it to a friend (Schaff et al. 1999; Winikoff, Ellertson,

Elul, & Sivin, 1998). Satisfaction is related to a woman’s prepa-

ration for medical abortion, such as pain tolerance assessment,

and plans for symptom management and psychosocial sup-

port (Goss, 2002). Table 2 compares the features of medical

abortion and vacuum aspiration for first trimester pregnancy

termination. Because women have different preferences and

responses, patients should receive information about both

alternatives.

Practitioners and Medical AbortionIn January 2003, a new California state law took effect that

clarifies the authority of appropriately licensed health care

personnel to provide medical abortion. The new California

law applies to a variety of advanced practice clinicians: nurse

practitioners, nurse midwives and physician assistants. Recent

surveys by the pro-choice Abortion Access Project of nurse

practitioners in Massachusetts and Oregon have found that a

large majority of respondents believe that medical abortion

should or might fall into their scope of practice.

Advocates for expanding the role of nurse practitioners and

other advanced practice clinicians (APCs) note that APCs

working in reproductive health are qualified in the clinical

skills required for medical abortion:

• performing a history and physical exam• confirming and dating pregnancies• counseling patients and managing complications through

referrals

Furthermore, clinical practice standards for advanced practice

nurses in general and women’s health nurse practitioners

specifically have been developed by national professional

organizations, such as AWHONN and the American Nurses

Association and the National Association of Nurse

Practitioners in Women’s Health, to recognize the independ-

ent scope of nursing practice in the provision of women’s pri-

mary care throughout the lifespan. More recently, the U.S.

Health Resources and Services Administration has published

primary care NP competencies with specialty competencies in

the areas of women’s health, family, adult, pediatrics and geri-

atrics care (available at www.nonpf.com). These competencies,

expected of all entry level NPs, specifically refer to the role of

the NP in women’s health to perform primary care procedures

such as IUD insertions and endometrial biopsies as well as to

prescribe therapies (e.g., hormonal drug therapies) related to

pregnancy.

In some states, there is a well-established precedent of

APCs, especially physician assistants, providing abortion. In

Vermont, for example, physician assistants have been provid-

ing vacuum aspiration abortions for 30 years. But in other

states, APCs have been prevented from independently provid-

ing abortion by physician-only laws.

Borgmann and Jones reviewed states’ physician-only laws

regarding providers of medical abortion (Borgmann & Jones,

2000). In some cases, it can be argued that when it comes to

medical abortion, more recent laws granting prescriptive

authority to APCs supercede physician-only restrictions. This

argument can be advanced through both legal cases and state

legislation, such as the new California law. In other states legal

research is needed to establish the legal support for the provi-

sion of medical abortion by nurse practitioners.

Unlike other medications, mifepristone must be dispensed

directly by the provider. Providers can obtain mifepristone by

December 2003 | January 2004 AWHONN Lifelines 527

signing a prescriber agreement with Danco, the distributor of

mifepristone in the U.S. (www.earlyoptionpill.com). The FDA

requires that medical abortion providers be able to:

• Assess the duration of pregnancy accurately• Diagnose ectopic pregnancies• Provide surgical intervention in cases of incomplete abor-

tion or severe bleeding or have made plans to provide suchcare through others

The need for backup care in case of incomplete abortion or

bleeding may strike providers as unusual. The need for this

type of care in medical abortion is no greater than for patients

who choose to continue their pregnancies. Women with con-

tinuing pregnancies are at equal risk for ectopic pregnancy and

have a 15 percent risk of spontaneous abortion within the first

12 weeks of pregnancy. The arrangements in place for urgent

care of pregnant women should already be familiar to any

provider who cares for women of reproductive age.

New providers of abortion services should be aware of any

restrictions imposed by their state, such as requirements for

parental notification, waiting periods and facilities or licens-

ing. The National Abortion Foundation (www.prochoice.org)

can provide interested clinicians with more information about

establishing abortion services. The Abortion Access Project

(www.abortionaccess.org) and Clinicians for Choice

(www.cliniciansforchoice.org) have information about APCs

and abortion.

Looking AheadMifepristone is a safe and effective method for the termi-

nation of early first trimester pregnancies. Approximately

80,000 women are estimated to have used mifepristone in the

first year after its approval, with 139 reported adverse events

(0.17 percent) (Hausknecht, 2003). Adverse events include:

• heavy bleeding requiring aspiration or, rarely, transfusion• treatment with antibiotics for presumed infection• allergic reaction (hives)• ectopic pregnancy• continuing pregnancy

528 AWHONN Lifelines Volume 7 Issue 6

Diana Taylor, RN, PhD, is professor emeritus, Department of

Family Health Care Nursing, University of California, San

Francisco. Ann C. Hwang, MD, is a research associate, Center for

Reproductive Health Research & Policy, University of California,

San Francisco.

DOI: 10.1177/1091592303261927

Table 2.

Comparison of Medical Abortion with Vacuum Aspiration for FirstTrimester Pregnancy Termination

Medical Abortion Vacuum Aspiration

Recommended gestational age: 7 or 9 weeks after LMP, Up to 12 weeks after LMPdepending on regimen selected

Effectiveness (percentage of patients Approximately 92 to 98 percent Approximately 99 percent requiring no further intervention):

Number of visits: Requires at least two visits Can be done in one visit

Duration: Abortion occurs within 24 hours of Procedure usually completedmisoprostol administration for in 5 to 10 minutesmost women

Where abortion occurs: Most of the process may happen at home Procedure conducted in medical office or clinic

Side effects, complications: Nausea, vomiting, diarrhea, headache, Pain and cramping at time of dizziness, fever or chills, anemia (rare); procedure; rare complicationspossible need for vacuum abortion; include excessive bleeding,rarely blood transfusion pelvic infection, injury to the

cervix, uterine perforation and acute hematometra

Expected bleeding: Median length of bleeding is 13 days Median length of bleeding is 9 days, for early first trimester

Ashok et al. (1998); Schaff et al. (1999); Spitz et al. (1998); Davis, Westhoff, & DeNonno (2000); National Abortion Federation (2003).

There was one fatality from a ruptured ectopic pregnancy.

In addition to the growing data on its use in the U.S., mifepri-

stone is approved for use in 27 countries and has already been

used for more than a decade in Europe and China. As

providers and the public become more familiar with it, it’s

likely to become a more popular choice for pregnancy termi-

nation for women in the U.S. Medical abortion also offers

interested nurse practitioners a new opportunity to expand

reproductive health choices, by providing their patients with

an additional safe and effective method for early pregnancy

termination.

References

Ashok, P. W., Penney, G. C., Flett, G. M., & Templeton, A.(1998). An effective regimen for early medical abor-tion: A report of 2000 consecutive cases. HumanReproduction, 13, 2962-2965.

Borgmann, C. E., & Jones, B. S. (2000). Legal issues in theprovision of medical abortion. American Journal ofObstetrics and Gynecology, 183(2), S84-S94.

Creinin, M. D., & Shulman, T. (1997). Effect of nonsteroidalanti-inflammatory drugs on the action of misoprostolin a regimen for early abortion. Contraception, 55, 1-5.

Davis, A., Westhoff, C., & DeNonno, L. (2000). Bleeding pat-terns after early abortion with mifepristone and miso-prostol or manual vacuum aspiration. Journal of theAmerican Medical Association, 55, 141-144.

El-Refaey, H., Rajasekar, M., Abdalla, M., Calder, L., &Templeton, A. (1995). Induction of abortion withmifepristone (RU-486) and oral or vaginal misopros-tol. New England Journal of Medicine, 322(15), 983-987.

Elul, B., Pearlman, E., Sorhaindo, A., Simonds, W., &Westhoff, C. (2000). In-depth interviews with medicalabortion clients: Thoughts on the method and homeadministration of misoprostol. Journal of the AmericanMedical Association, 55, 169-172.

Goss, G. L. (2002). Understanding and supporting womenwho undergo medical abortion. AWHONN Lifelines,6(1), 47-50.

Hausknecht, R. (2003). Mifepristone and misoprostol forearly medical abortion: 18 months experience in theU.S. Contraception, 67(6), 463-465.

Henshaw, S. K. (1998). Unintended pregnancy in the U.S.Family Planning Perspectives, 30(1), 24-29, 46.

Kruse, B., Poppema, S., Creinin, M. D., & Paul, M. (2000).Management of side effects and complications in med-ical abortion. American Journal of Obstetrics andGynecology, 183, S65-D75.

National Abortion Federation. Comparison of first trimesterabortion options. Retrieved June 17, 2003, fromwww.prochoice.org/facts/factsheets/fs11.pdf

Philip, N. M., Shannon, C., & Winikoff, B. (2003). Misoprostoland teratogenicity: Reviewing the evidence (The RobertH. Ebert Program on Critical Issues in ReproductiveHealth). New York City: Population Council.

Schaff, E. A., Eisinger, S. H., Stadalius, L. S., Franks, P., Gore,B. Z., & Poppema, S. (1999). Low-dose mifepristone200 mg and vaginal misoprostol for abortion.Contraception, 59(1), 1-6.

Schaff, E. A., Fielding, S. L., & Westhoff, C. (2001).Randomized trial of oral versus vaginal misoprostol atone day after mifepristone for early medical abortion.Contraception, 64, 81-85.

Schaff, E. A., Fielding, S. L., & Westhoff, C. (2002).Randomized trial of oral versus vaginal misoprostol 2days after mifepristone 200 mg for abortion up to 63days of pregnancy. Contraception, 66, 247-250.

Schaff, E. A., Fielding, S. L., Westhoff, C., Ellertson, C.,Eisinger, S. H., Stadalius, L. S., et al. (2000). Vaginalmisoprostol administered 1, 2, or 3 days after mifepris-tone for early medical abortion: A randomized trial.Journal of the American Medical Association, 284(15),1948-1953.

Schaff, E. A., Stadalius, L. S., Eisinger, S. H., & Franks, P.(1997). Vaginal misoprostol administered at home aftermifepristone (RU-486) for abortion. Journal of FamilyPractice, 44(4), 353-360.

Spitz, I. M., Bardin, C. W., Benton, L., & Robbins, A. (1998).Early pregnancy termination with mifepristone andmisoprostol in the U.S. New England Journal ofMedicine, 338(18), 1241-1247.

Suhonen, S., Heikinheimo, O., Tikka, M., & Haukkamaa, M.(2003). The learning curve is rapid in medical termina-tion of pregnancy——first-year results from theHelsinki area. Contraception, 67, 223-227.

Winikoff, B., Ellertson, C., Elul, B., & Sivin, I. (1998).Acceptability and feasibility of early pregnancy termi-nation by mifepristone-misoprostol. Results of a largemulticenter trial in the U.S. Mifepristone Clinical TrialsGroup. Archives of Family Medicine, 7(4), 360-366.

December 2003 | January 2004 AWHONN Lifelines 529

Box 1.

Getting All the Facts

Resources for nurse practitioners to prepare them-selves for providing medical abortions include generalnursing care and counseling recommendations pub-lished in Lifelines (Goss, 2002) and an online CME-accredited training course available from www.earlyop-tions.org/online_cme/default.asp.

These training materials will provide the NP withthe knowledge necessary for providing medical abor-tions including:• clinical competency in prescribing FDA-approved

medical abortion protocols• clinical management and counseling essentials

across the abortion process • the use of ultrasonography pre- and post-medical

abortion

Additional resources are available at:• The National Abortion Foundation: www.prochoice.org• The Abortion Access Project: www.abortionaccess.org• Clinicians for Choice: www.cliniciansforchoice.org