Ibis Reproductive Health1 Medication Abortion A training module for health professionals

Ibis Reproductive Health 1

Medication AbortionA training module for health professionals


Ibis Reproductive HealthIbis Reproductive Health aims to improve women’s reproductive health, choices, and autonomy worldwide. Our work includes clinical and social science research, policy analysis, and evidence-based advocacy.


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


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.


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.


Methods of medication abortionMifepristone and misoprostolMethotrexate and misoprostolMisoprostol alone

Medication abortion methods can be used throughout early pregnancy (≤63 days’ gestation)


Medication abortionMethods 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

Misoprostol Prostaglandin E1 analog Stimulates uterine contractions and induces cervical

softening


Medication abortion Additional uses of the medications Mifepristone

Labor induction (under investigation) Infertility treatment (under investigation)

Methotrexate Treatment of neoplastic diseases Treatment of rheumatoid arthritis

Misoprostol Prevention of gastric ulcers Obstetric and gynecologic indications


Mifepristone/misoprostol regimen


MifepristoneWorldwide approval

Mifepristone Approval (2002)


Mifepristone/misoprostol regimenGeneral protocol Day 1 (Clinic)

Clinician counsels the woman, takes a medical history and performs an exam and lab tests

Mifepristone is orally administered Day 2-4 (Home or clinic)

Misoprostol is administered Day 7-14 (Clinic)

Patient returns to the clinic for follow-up Clinician assesses for the completion of the abortion


Mifepristone/misoprostol regimensComparison of protocols

French Regimen US: FDA Regimen Evidence-Based Regimen

Mifepristone Dosage 600 mg (Day 1) 600 mg (Day 1) 200 mg (Day 1)

Misoprostol Dosage 400 µg, PO

Or 1mg gemeprost, PV

400 µg, PO 400 µg, PO or 800 µg, PV

Gestational Limit ≤ 49 days ≤ 49 days ≤ 63 days

Location of misoprostol administration

At medical office/clinic At medical office/clinic At medical office/clinic or at home

Timing of misoprostol administration

Day 2 or 3 Day 3 Day 2, 3, or 4

Timing of initial follow-up examination

Day 10 to 14 Day 14 Day 4 to 14

Number of clinic visits required

Three or more Three or more Two or more


Mifepristone/misoprostol regimenEfficacy 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.


Mifepristone/misoprostol regimenEligibility 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


Mifepristone/misoprostol regimenContraindications 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


Mifepristone/misoprostol regimenSide effects

Effects of abortion process Cramping

Often described as similar to menstrual cramps

Vaginal bleeding Median bleeding time 9-13

days Often described as similar to

a heavy period or spontaneous miscarriage

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

warmth


Mifepristone/misoprostol regimenComplications

Type of complication Percentage of women

Continued pregnancy 1%-5%

Incomplete abortion requiring aspiration

1%

Hemorrhage requiring aspiration

1%-2%

Hemorrhage requiring transfusion

0.1%


Mifepristone/misoprostol regimenSummary

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


Methotrexate/misoprostol regimen


MethotrexateWorldwide availability

Methotrexate Availability (2002)

Registered

Status of the medication is

unknown


Methotrexate/misoprostol regimenEvidence-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)

Day 3-7 (Home) Misoprostol is self-administered vaginally at home.

Day 8 (Clinic) 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 On Day 15 if cardiac activity is detected On Day 28-45 if no cardiac activity is detected on ultrasound


Methotrexate/misoprostol regimenEvidence-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. Day 28-45 (Clinic, if necessary)

The patient is assessed for continued pregnancy. If the abortion is incomplete (5% of cases), a aspiration

termination is performed.


Methotrexate/misoprostol regimenEfficacy 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.


Methotrexate/misoprostol regimenEligibility 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


Methotrexate/misoprostol regimenContraindications 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.


Methotrexate/misoprostol regimenSide EffectsEffects of abortion process Cramping


Vaginal bleeding Median bleeding time 2-3

weeks Often described as similar to

a heavy period or spontaneous miscarriage

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

warmth Oral ulcers Fetal malformations


Methotrexate/misoprostol regimenComplications (≤49 days’ gestation)

Type of complication Percentage of women

Continued pregnancy 3-5%

Incomplete abortion requiring aspiration

3-5%

Hemorrhage requiring aspiration

1%-2%

Hemorrhage requiring transfusion

0.1%-0.5%


Methotrexate/misoprostol regimenSummary

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


Misoprostol-only regimen


MisoprostolWorldwide availability

Misoprostol Availability (2002)


Misoprostol-only regimenEvidence-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 µg of misoprostol If abortion fails, misoprostol dose is repeated

every 24 hours, up to three doses


Misoprostol-only regimenEfficacy 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


Misoprostol-only regimenEligibility 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


Misoprostol-only regimenContraindications for use

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


Misoprostol-only regimenSide effectsEffects of abortion process Cramping


Often described as more severe than the cramping of either mifepristone/misoprostol or methotrexate/misoprostol regimens

Vaginal bleeding Median bleeding time 2 weeks Often described as similar to a

heavy period or spontaneous miscarriage

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


Misoprostol-only regimenComplications

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


Misoprostol-only regimenSummary 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


Medication abortion: General issues


Medication abortionComparing the three regimens

Regimen Advantages DisadvantagesMifepristone/

misoprostol

High efficacy (≈95%)

Can be used through 63 days’ gestation

Abortion typically occurs within hours of misoprostol administration

Mifepristone is often expensive

Mifepristone is not available in many countries

Can not be used to treat ectopic pregnancies

Methotrexate/

misoprostol

High efficacy (90%-95%)

Can be used through 56 days’ gestation

Often less expensive than mifepristone

Treats ectopic pregnancies

Abortion can occur over a four week period

May cause fetal abnormalities in continued pregnancies

Efficacy decreases after 49 days’ gestation

Misoprostol-only Can be used through 63 days’ gestation

Widely available worldwide

Often very inexpensive

Stable at room temperature

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


Medication abortionSpecial 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


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 β-hCG testing Ultrasound


Alternatives to medication abortionAspiration abortion Types of aspiration abortion

Manual vacuum aspiration Dilation and curettage (D&C)

Aspiration procedure Cannula is inserted into the uterus Uterine contents are emptied through suction

Can be used throughout the first trimester Highly effective (>99%) in terminating pregnancy


Medication abortion vs. aspiration abortionAdvantages and disadvantages

Method Advantages Disadvantages

Medication abortion 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)

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

Aspiration abortion High success rate (>99%)

May require only one clinic visit

Procedure completed within minutes

Sedation is available

Involves an invasive procedure

May not be available very early in pregnancy

Often considered to be “less private”

Quality of facilities may vary significantly


Medication abortionConditions requiring clinical assessment and/or intervention

Fever Excessive or prolonged bleeding Incomplete abortion

Retained fetal tissue Persistent gestational sac on ultrasound

Continued pregnancy


Medication abortion regimensAcceptability 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 well-accepted by providers


Medication abortion regimensBest 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

Women report the worst features as Length and degree of bleeding Number of clinic visits Uncertainty as to whether or not the procedure had

resulted in a complete abortion.


Medication abortionFuture 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


Medication AbortionConclusions 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


Medication AbortionReferences and resourcesThe 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.

Documents

Ibis Reproductive Health1 Medication Abortion A training module for health professionals