Transcript Medical Abortion - Medication Abortion

Medication Abortion
A training module for health professionals
Ibis Reproductive Health
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Ibis Reproductive Health
Ibis Reproductive Health
aims to improve women’s
reproductive health,
choices, and autonomy
worldwide. Our work
includes clinical and social
science research, policy
analysis, and evidencebased advocacy.
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Objectives
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Define medication abortion
Identify current medication abortion methods and
present
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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
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Mifepristone
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Methotrexate
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Anti-progestin that blocks the action of progesterone
Alters the uteral lining
Anti-metabolite
Interferes with DNA synthesis and cell growth
Misoprostol
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Prostaglandin E analog
Stimulates uterine contractions and induces cervical
softening
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Medication abortion
Additional uses of the medications
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Mifepristone
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Methotrexate
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Labor induction (under investigation)
Infertility treatment (under investigation)
Treatment of neoplastic diseases
Treatment of rheumatoid arthritis
Misoprostol
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Prevention of gastric ulcers
Obstetric and gynecologic indications
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Mifepristone/misoprostol regimen
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Mifepristone
Worldwide approval
Mifepristone Approval (2002)
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Mifepristone/misoprostol regimen
General protocol
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Day 1 (Clinic)
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Day 2-4 (Home or clinic)
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Clinician counsels the woman, takes a medical history and
performs an exam and lab tests
Mifepristone is orally administered
Misoprostol is administered
Day 7-14 (Clinic)
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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
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 followup 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
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Mifepristone/misoprostol regimen
Efficacy and safety
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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
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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
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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
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Often described as similar to
menstrual cramps
Vaginal bleeding
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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
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Mifepristone/misoprostol regimen
Complications
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%
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Mifepristone/misoprostol regimen
Summary
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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
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Day 1 (Clinic)
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Day 3-7 (Home)
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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.
Day 8 (Clinic)
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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
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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
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Day 15 (Clinic, if necessary)
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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)
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The patient is assessed for continued pregnancy.
If the abortion is incomplete (5% of cases), a aspiration
termination is performed.
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Methotrexate/misoprostol regimen
Efficacy and safety
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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
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Pregnancy of ≤49 days’ gestation
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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
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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
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Often described as similar to
menstrual cramps
Vaginal bleeding
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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
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Methotrexate/misoprostol regimen
Complications (≤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%
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Methotrexate/misoprostol regimen
Summary
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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
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No consensus exists on optimal protocol
Various regimens, dosing schedules and
routes of administration are currently under
investigation
Most commonly used protocol
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Vaginal administration of 800 µg 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
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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
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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
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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
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Cramping
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Often described as similar to
menstrual cramps
Often described as more severe
than the cramping of either
mifepristone/misoprostol or
methotrexate/misoprostol
regimens
Vaginal bleeding
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Median bleeding time 2 weeks
Often described as similar to a
heavy period or spontaneous
miscarriage
Common side effects
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Nausea
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Vomiting
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Diarrhea
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Headache
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Dizziness
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Fever and chills
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Rashes
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Pelvic pain
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Fetal malformations
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Misoprostol-only regimen
Complications
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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
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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
Advantages
Disadvantages
Mifepristone/
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
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Medication abortion
Special considerations for early pregnancy termination
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Determine eligibility for medication abortion
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Discuss medical and aspiration options
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Diagnose and accurately date of early pregnancy
Inform patients of potential side effects,
complications, and follow-up requirements
Provide adequate follow-up and post abortion
care
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Aspiration intervention, if necessary
Family planning services
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Methods for determining gestational age
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For all medication abortion methods, accurate
pregnancy dating is important
Methods for determining gestation age
include
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Last menstrual period
Bimanual examination
Serum β-hCG testing
Ultrasound
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Alternatives to medication abortion
Aspiration abortion
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Types of aspiration abortion
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Aspiration procedure
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Manual vacuum aspiration
Dilation and curettage (D&C)
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
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Medication abortion vs. aspiration abortion
Advantages 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
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Medication abortion
Conditions requiring clinical assessment and/or intervention
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Fever
Excessive or prolonged bleeding
Incomplete abortion
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Retained fetal tissue
Persistent gestational sac on ultrasound
Continued pregnancy
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Medication abortion regimens
Acceptability
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Generally well-accepted by patients who
report
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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
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Women report the best features as
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Ability to avoid surgery and anesthesia
Perception that the process is more “natural”
Privacy
Convenience
Women report the worst features as
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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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Medication abortion
Future directions for research and clinical practice
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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
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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
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This site provides numerous studies on abortion in the US and worldwide.
American College of Obstetricians and Gynecologists: www.acog.org
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This website provides information on the medical management of abortion and resources on
practice guidelines.
Ibis Reproductive Health: www.ibisreproductivehealth.org
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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
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IPAS manufactures and distributes manual vacuum aspiration equipment and trains
providers in early abortion techniques worldwide.
National Abortion Federation: www.earlyoptions.org
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This site provides medication abortion educational materials for both providers and patients.
Population Council: www.popcouncil.org
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The Population Council provides information on reproductive health issues worldwide,
including publications on medication abortion methods and acceptability.
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