Medication Abortion

A training module for health professionals

Ibis Reproductive Health

Ibis Reproductive Health

Ibis Reproductive Health aims to improve womens reproductive health, choices, and autonomy worldwide. Our work includes clinical and social science research, policy analysis, and evidencebased advocacy.
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Objectives

Define medication abortion Identify current medication abortion methods and present

Mechanisms of action Regimens, efficacy, and safety Eligibility requirements and contraindications Side effects and complications

Provide general information on medication abortion methods Outline references and resources
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What is medication abortion?

Medication abortion, also known as non-aspiration or non-surgical abortion, refers to a family of safe and effective methods for terminating an early unwanted pregnancy. Through the use of a drug or combination of drugs that are administered orally, vaginally, and/or intramuscularly, medication abortion first causes the pregnancy to terminate and then causes the uterus to expel the products of conception.

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Why medication abortion?

Non-aspiration or non-surgical abortion is commonly referred to as medical abortion. However, this phrase has led to confusion among both providers and the public, as the term medical is often associated with physician-based practices and/or medical necessity.
Medication abortion more accurately represents the family of safe and effective drug-based methods that can terminate an unwanted pregnancy and will be used throughout this presentation.
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Methods of medication abortion

Mifepristone

and misoprostol Methotrexate and misoprostol Misoprostol alone

Medication abortion methods can be used throughout early pregnancy (63 days gestation)
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Medication abortion Methods of action of the medications

Mifepristone

Anti-progestin that blocks the action of progesterone Alters the uteral lining

Methotrexate

Anti-metabolite Interferes with DNA synthesis and cell growth Prostaglandin E analog Stimulates uterine contractions and induces cervical softening
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Misoprostol

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Medication abortion Additional uses of the medications

Mifepristone

Labor induction (under investigation) Infertility treatment (under investigation) Treatment of neoplastic diseases Treatment of rheumatoid arthritis Prevention of gastric ulcers Obstetric and gynecologic indications
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Methotrexate

Misoprostol

Mifepristone/misoprostol regimen

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Mifepristone Worldwide approval

Mifepristone Approval (2002)

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Mifepristone/misoprostol regimen General protocol

Day 1 (Clinic)

Clinician counsels the woman, takes a medical history and performs an exam and lab tests Mifepristone is orally administered Misoprostol is administered

Day 2-4 (Home or clinic)

Day 7-14 (Clinic)

Patient returns to the clinic for follow-up Clinician assesses for the completion of the abortion
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Mifepristone/misoprostol regimens Comparison of protocols

French Regimen Mifepristone Dosage Misoprostol Dosage Gestational Limit Location of misoprostol administration Timing of misoprostol administration Timing of initial followup examination Number of clinic visits required 600 mg (Day 1) 400 g, PO Or 1mg gemeprost, PV 49 days At medical office/clinic Day 2 or 3 Day 10 to 14 Three or more US: FDA Regimen 600 mg (Day 1) 400 g, PO 49 days At medical office/clinic Day 3 Day 14 Three or more Evidence-Based Regimen 200 mg (Day 1) 400 g, PO or 800 g, PV 63 days At medical office/clinic or at home Day 2, 3, or 4 Day 4 to 14 Two or more

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Mifepristone/misoprostol regimen Efficacy and safety

Approximately 95% of women will have a successful abortion when using mifepristone/misoprostol within 49 days gestation Completion rates appear to decline slightly with increasing durations of pregnancy after 56 days gestation Approximately 67% of women will have a complete abortion within four hours of using misoprostol Approximately 90% of women will have a complete abortion within 24 hours of using misoprostol.
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Mifepristone/misoprostol regimen Eligibility for use

Non-ectopic pregnancy of 63 days gestation Absence of contraindications Willingness to undergo vacuum aspiration or dilation and curettage (D&C), if indicated

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Mifepristone/misoprostol regimen Contraindications to use

Confirmed or suspected ectopic (extra-uterine) pregnancy Allergy to either mifepristone or misoprostol Presence of an intrauterine device (IUD) Chronic systemic use of corticosteroids Chronic adrenal failure Coagulopathy or current therapy with anticoagulants Inherited porphyria
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Mifepristone/misoprostol regimen Side effects

Effects of abortion process Cramping

Often described as similar to menstrual cramps Median bleeding time 9-13 days Often described as similar to a heavy period or spontaneous miscarriage

Vaginal bleeding

Common side effects Nausea Vomiting Diarrhea Headache Dizziness Fever, chills, hot flashes, warmth

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Mifepristone/misoprostol regimen Complications

Type of complication
Continued pregnancy Incomplete abortion requiring aspiration Hemorrhage requiring aspiration Hemorrhage requiring transfusion
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Percentage of women
1%-5% 1% 1%-2% 0.1%

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Mifepristone/misoprostol regimen Summary

Millions of women worldwide have safely used mifepristone/misoprostol Mifepristone/misoprostol is more than 95% effective in terminating early pregnancies Mifepristone/misoprostol is widely acceptable to both patients and providers

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Methotrexate/misoprostol regimen

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Methotrexate Worldwide availability

Methotrexate Availability (2002)

Registered Status of the medication is unknown

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Methotrexate/misoprostol regimen Evidence-based protocol

Day 1 (Clinic)

Clinician counsels the woman, takes a medical history and performs an exam and lab tests. Methotrexate is administered either orally (50 mg) or intramuscularly (50 mg/m2) Misoprostol is self-administered vaginally at home.
Clinician performs a vaginal ultrasound to determine if the abortion is complete. If abortion is complete (75% of women) no further visits are required. If the abortion is incomplete additional misoprostol is given and patient returns

Day 3-7 (Home)

Day 8 (Clinic)

On Day 15 if cardiac activity is detected On Day 28-45 if no cardiac activity is detected on ultrasound

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Methotrexate/misoprostol regimen Evidence-based protocol continued

Day 15 (Clinic, if necessary)

Patient is assessed for continued pregnancy. If cardiac activity is detected, a aspiration termination is performed. If no cardiac activity is detected, patient returns in three weeks. The patient is assessed for continued pregnancy. If the abortion is incomplete (5% of cases), a aspiration termination is performed.
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Day 28-45 (Clinic, if necessary)

Methotrexate/misoprostol regimen Efficacy and safety

Approximately 95% of women will have a complete abortion when using methotrexate/misoprostol up to 49 days gestation. Medication abortion completion rates decline with increasing gestational age Approximately 20% of patients using methotrexate/misoprostol will experience a complete abortion three to four weeks after misoprostol administration.
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Methotrexate/misoprostol regimen Eligibility for use

Pregnancy of 49 days gestation

Methotrexate/misoprostol is preferable for women with ectopic pregnancies

Absence of contraindications Willingness to undergo vacuum aspiration or dilation and curettage (D&C), if indicated

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Methotrexate/misoprostol regimen Contraindications to use

Allergy to either methotrexate or misoprostol Presence of an intrauterine device (IUD) Coagulopathy or current severe anemia Acute or chronic renal or hepatic disease Acute inflammatory bowel disease Uncontrolled seizure disorders.

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Methotrexate/misoprostol regimen Side Effects

Effects of abortion process Cramping

Often described as similar to menstrual cramps Median bleeding time 2-3 weeks Often described as similar to a heavy period or spontaneous miscarriage

Vaginal bleeding

Common side effects Nausea Vomiting Diarrhea Headache Dizziness Fever, chills, hot flashes, warmth Oral ulcers Fetal malformations
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Methotrexate/misoprostol regimen Complications (49 days gestation)

Type of complication
Continued pregnancy Incomplete abortion requiring aspiration Hemorrhage requiring aspiration Hemorrhage requiring transfusion
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Percentage of women
3-5% 3-5% 1%-2% 0.1%-0.5%
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Methotrexate/misoprostol regimen Summary

Methotrexate/misoprostol is approximately 95% effective in terminating pregnancies 49 days gestation Methotrexate/misoprostol is the preferred medication abortion method for confirmed or suspected ectopic pregnancies Methotrexate/misoprostol is widely acceptable to both patients and providers
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Misoprostol-only regimen

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Misoprostol Worldwide availability

Misoprostol Availability (2002)

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Misoprostol-only regimen Evidence-based protocols

No consensus exists on optimal protocol Various regimens, dosing schedules and routes of administration are currently under investigation Most commonly used protocol

Vaginal administration of 800 g of misoprostol If abortion fails, misoprostol dose is repeated every 24 hours, up to three doses
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Misoprostol-only regimen Efficacy and Safety

Efficacy varies widely (65%-93%) Efficacy varies by route of administration, dose, dosing schedule, and gestational age Misoprostol-only regimens are not as effective as either mifepristone/misoprostol or methotrexate/misoprostol regimens

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Misoprostol-only regimen Eligibility for use

Non-ectopic pregnancy of 63 days gestation Absence of contraindications Willingness to undergo vacuum aspiration or dilation and curettage (D&C), if indicated Lack of access to either mifepristone or methotrexate

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Misoprostol-only regimen Contraindications for use

Confirmed or suspected ectopic pregnancy Allergy to misoprostol Presence of an intrauterine device (IUD) Uncontrolled seizure disorder Inflammatory bowel disease

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Misoprostol-only regimen Side effects

Effects of abortion process Cramping

Often described as similar to menstrual cramps Often described as more severe than the cramping of either mifepristone/misoprostol or methotrexate/misoprostol regimens Median bleeding time 2 weeks Often described as similar to a heavy period or spontaneous miscarriage

Vaginal bleeding

Common side effects Nausea Vomiting Diarrhea Headache Dizziness Fever and chills Rashes Pelvic pain Fetal malformations

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Misoprostol-only regimen Complications

Approximately 10%-35% of women will require an aspiration intervention Misoprostol-only regimen is less effective in terminating early pregnancy than when used in combination with either mifepristone or methotrexate

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Misoprostol-only regimen Summary

Misoprostol used in conjunction with either mifepristone or methotrexate is more effective at terminating early pregnancy than misoprostol alone Efficacy varies widely Optimal regimen has yet to be determined Misoprostol-only regimen is an important alternative for women who do not have access to other medical or aspiration abortion methods
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Medication abortion: General issues

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Medication abortion Comparing the three regimens

Regimen
Mifepristone/ misoprostol

Advantages
High efficacy (95%) Can be used through 63 days gestation Abortion typically occurs within hours of misoprostol administration High efficacy (90%-95%) Can be used through 56 days gestation Often less expensive than mifepristone Treats ectopic pregnancies Can be used through 63 days gestation Widely available worldwide Often very inexpensive Stable at room temperature

Disadvantages
Mifepristone is often expensive Mifepristone is not available in many countries Can not be used to treat ectopic pregnancies Abortion can occur over a four week period May cause fetal abnormalities in continued pregnancies Efficacy decreases after 49 days gestation Efficacy is variable (65%-90%) Regimen is currently under investigation May cause fetal anomalies in continued pregnancies Can not be used to treat ectopic pregnancies

Methotrexate/ misoprostol

Misoprostol-only

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Medication abortion
Special considerations for early pregnancy termination

Determine eligibility for medication abortion

Diagnose and accurately date of early pregnancy

Discuss medical and aspiration options

Inform patients of potential side effects, complications, and follow-up requirements

Provide adequate follow-up and post abortion care

Aspiration intervention, if necessary Family planning services

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Methods for determining gestational age

For all medication abortion methods, accurate pregnancy dating is important Methods for determining gestation age include

Last menstrual period Bimanual examination Serum -hCG testing Ultrasound

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Alternatives to medication abortion Aspiration abortion

Types of aspiration abortion

Manual vacuum aspiration Dilation and curettage (D&C) Cannula is inserted into the uterus Uterine contents are emptied through suction

Aspiration procedure

Can be used throughout the first trimester Highly effective (>99%) in terminating pregnancy
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Medication abortion vs. aspiration abortion Advantages and disadvantages

Method
Medication abortion

Advantages
Used early during pregnancy Resembles a natural miscarriage Often considered more private Usually avoids aspiration intervention Anesthesia not required High success rates (for mifepristone/misoprostol and methotrexate/misoprostol regimens) High success rate (>99%) May require only one clinic visit Procedure completed within minutes Sedation is available

Disadvantages
Often requires at least two clinic visits Takes days, sometimes weeks to complete Efficacy decreases at later gestational ages Women may see blood clots and the products of conception Mifepristone and/or methotrexate may not be available Mifepristone can be expensive Involves an invasive procedure May not be available very early in pregnancy Often considered to be less private Quality of facilities may vary significantly
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Aspiration abortion

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Medication abortion
Conditions requiring clinical assessment and/or intervention

Fever Excessive or prolonged bleeding Incomplete abortion

Retained fetal tissue Persistent gestational sac on ultrasound

Continued pregnancy

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Medication abortion regimens Acceptability

Generally well-accepted by patients who report

High satisfaction Desire to use the method again Intention to recommend method to a friend or relative

Both mifepristone/misoprostol and methotrexate/misoprostol regimens are wellaccepted by providers

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Medication abortion regimens Best and worst reported features

Women report the best features as

Ability to avoid surgery and anesthesia Perception that the process is more natural Privacy Convenience Length and degree of bleeding Number of clinic visits Uncertainty as to whether or not the procedure had resulted in a complete abortion.
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Women report the worst features as

Medication abortion
Future directions for research and clinical practice

Expand worldwide access to medication abortion medications Establish optimal misoprostol-only regimens Expand programs to educate women, health professionals, and policy makers about medication abortion Train health professionals in medication abortion provision
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Medication Abortion Conclusions

Medication abortion regimens have been used by millions of women worldwide to safely and effective terminate early pregnancy Medication abortion regimens expand pregnancy termination options for women and health professionals Medication abortion regimens are highly acceptable to both women and providers Future research is needed to improve regimens and expand services
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Medication Abortion References and resources

The Alan Guttmacher Institute: www.agi-usa.org This site provides numerous studies on abortion in the US and worldwide. American College of Obstetricians and Gynecologists: www.acog.org This website provides information on the medical management of abortion and resources on practice guidelines. Ibis Reproductive Health: www.ibisreproductivehealth.org The home page of Ibis Reproductive Health, this site provides information on the organization and contains a database of articles published by staff. Ibis also provides educational materials on medication abortion in English, Arabic, French, and Spanish. IPAS: www.ipas.org IPAS manufactures and distributes manual vacuum aspiration equipment and trains providers in early abortion techniques worldwide. National Abortion Federation: www.earlyoptions.org This site provides medication abortion educational materials for both providers and patients. Population Council: www.popcouncil.org The Population Council provides information on reproductive health issues worldwide, including publications on medication abortion methods and acceptability.

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