Transcript Side Effect

EARLY OPTIONS
A PROVIDER’S GUIDE TO MEDICAL ABORTION
Medical Education Series
© 2005 National Abortion Federation
Objectives
• Identify expected side effects and possible
complications of medical abortion
• Discuss the management of the side effects
and complications of medical abortion
Overview
• Background: safety, definitions, counseling issues
• “Expected” side effects and their management
• Complications and their management
• Case studies
Outstanding Safety Record
• Mifepristone/misoprostol
– Impressive safety record in 400,000 U.S. women
– Used safely by millions of women worldwide
• Methotrexate/misoprostol
– More than 5,000 cases in the published literature
– Used safely by tens of thousands of women
• Misoprostol alone
– Important option where mifepristone and
methotrexate are not available or affordable
Definitions
Side Effect
Effect of treatment, other than the intended
outcome, that might include physiological
or psychological consequences
Complication
Effect resulting from treatment that has
potentially serious clinical consequences
and requires medical intervention
Abortion Counseling
• Women will be more involved in the
process of medical abortion as compared
to vacuum aspiration
• Preparing women for side effects is a critical
component of counseling
• The quality of counseling correlates with the
level of patient satisfaction with abortion care
Abortion Counseling
• Vacuum aspiration
– Serious complications rare and usually result
from anesthesia or instrumentation of the uterus
– Side effects rarely reported
• Medical abortion
– Serious complications rare
– Most side effects are medication-induced:
nausea, vomiting, diarrhea, fever
– Process of aborting has “side effects”
Overview
• Background: safety, definitions, counseling issues
• “Expected” side effects and their management
• Complications and their management
• Case studies
Expected Side Effects of
Medical Abortion
• Pain
• Bleeding
• Nausea, vomiting, diarrhea
• Short-term temperature elevation or chills
• Headache, dizziness
Management of
Common Side Effects: Pain
• Cramping occurs in > 90% of patients1
• Provide pain medications with initiation
of treatment
• Counseling and reassurance crucial to
pain management
1Spitz,
et al. New Engl J Med 1998
Management of
Common Side Effects: Pain
• Medications for pain control
– Non-narcotic analgesics
• Acetaminophen
• NSAIDs—can be used with misoprostol
– Narcotic analgesics
• Palliative measures
– Heating pad
– Hot water bottle
– Relaxation techniques
Management of
Common Side Effects: Bleeding
• Usually exceeds typical menstrual bleeding
– If patient saturates 2 maxipads/hour for 2
consecutive hours, contact provider
– Surgical intervention to control bleeding:
0.4% to 2.6%1,2
– Transfusion required: 0.2%2
• Longer duration than with vacuum aspiration
• No significant difference in total blood loss
between medical abortion & vacuum aspiration
1Ashok,
2Spitz,
et al. Hum Reprod 1998
et al. New Engl J Med 1998
Management of
Common Side Effects:
Nausea, Vomiting, and Diarrhea
• Usually short in duration
• Provide reassurance
• Rarely needs medication
Management of
Common Side Effects:
Fever/Chills
• Result of misoprostol or the abortion process
• Antipyretics as appropriate
• Suspect infection with:
– Sustained fever > 100.4°F
– Fever 24 hours or more after misoprostol
Overview
• Background: safety, definitions, counseling issues
• “Expected” side effects and their management
• Complications and their management
• Case studies
Medical Abortion: Complications
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Continuing pregnancy
Persistent gestational sac
Persistent bleeding requiring surgical intervention
Hemorrhage
Infection
Undiagnosed ectopic pregnancy
Meta-Analysis: Various Regimens
Mifepristone/Misoprostol (< 49
days)
100%
96.0%
75%
50%
25%
2.9%
1.1%
0%
Success
Incomplete
Abortion
Continuing
Pregnancy
Kahn, et al. Contraception 2000
Management of Complications:
Continuing Pregnancy
• The presence of a developing pregnancy
2 weeks after first medication
• Treatment: uterine aspiration
• Incidence (meta-analysis):
– Mifepristone/oral or vaginal misoprostol
1.1% of cases ( 49 days’ gestation)
– Methotrexate/vaginal misoprostol
2.7% of cases ( 49 days’ gestation)
Kahn, et al. Contraception 2000
Management of Complications:
Persistent Gestational Sac/Persistent Bleeding
• Perform ultrasound examination if
clinically suspected
• Treatment options
– Observation and re-evaluation
– Repeat misoprostol
– Uterine aspiration
Persistent Gestational Sac
Persistent Bleeding
Management of Complications:
Hemorrhage
• Difficult to quantify amount of bleeding
• Guideline: patients should contact provider
if they saturate 2 or more maxipads/hour
for 2 consecutive hours
• Defining clinically significant hemorrhage
– Drop in hemoglobin/hematocrit
– Hypovolemia
– Orthostatic hypotension
• Timing of heavy bleeding
Management of Complications:
Infection
• Rarely occurs in medical abortion
– 0.28% - 0.92%1
• Rule out retained products of conception
• Treatment: antibiotics
1Shannon,
et al. Contraception 2004
Management of Complications:
Undiagnosed Ectopic Pregnancy
• Providers should have established protocols for
diagnosis and management
• Methotrexate > 90% effective
• Mifepristone, misoprostol not effective
treatments
Proposed Criteria for Surgical
Intervention in Medical Abortion
• Continuing pregnancy
• Incomplete abortion unresponsive
to medical treatment
• Orthostatic hypotension
• Anemia, especially with ongoing blood loss
• Patient unable to return; no access
to emergency services
• Subjective symptoms unresponsive
to medical treatment
• Patient preference
Timing of Surgical Intervention
• Emergent
– Severe hemorrhage occurs
SHOULD BE DONE URGENTLY
• Nonemergent
– Continuing pregnancy
– Incomplete abortion without hemorrhage
– Patient choice
CAN BE SCHEDULED AT CONVENIENCE OF
PATIENT AND PROVIDER
Conclusion
• Medical abortion is safe and effective
• Establish guidelines for management
of side effects and complications
– Side effects are expected
– Complications may occur but are uncommon
• Patients should have 24-hour access to
backup care
• Clinicians must have arrangements established
for vacuum aspiration, if needed
Overview
• Background: safety, definitions, counseling issues
• “Expected” side effects and their management
• Complications and their management
• Case studies
Case Study 1
• 23-year-old G2P1
• 200 mg mifepristone PO
• 800 µg misoprostol PV
(at home) 2 days later
• 3 hours after misoprostol,
patient complains of severe
cramping and bleeding (3
pads/2 hours)
• Pretreatment Hct: 37%
Optimal management would
consist of which of the following?
1. Uterine aspiration
2. Reassurance and treatment
with analgesics
3. Methergine, 0.2 mg IM
4. Uterine packing
Case Study 2
• 34-year-old G4P3
• 6 weeks LMP
• Medical abortion with
mifepristone/misoprostol
• Calls to report mild vaginal
bleeding 2 days after misoprostol
• Office visit 2 days later
The clinical picture is consistent
with which of the following?
1. Continuing pregnancy
2. Persistent gestational sac
3. Retained pregnancy tissue
requiring vacuum aspiration
Case Study 3
• 25-year-old G1P0
• 42 days’ gestation
• Mifepristone/misoprostol
• No bleeding after misoprostol
• Ultrasound performed 12
days after misoprostol,
with cardiac activity present
Optimal management would
consist of which of the following?
1. Vacuum aspiration
2. Observation
3. Methergine, 0.2 mg IM
Case Study 4
• 28-year-old G3P0
• 34 days’ gestation
• Positive pregnancy test
• Pelvic exam normal
• Ultrasound obtained
Appropriate management consists
of which of the following?
1. Misoprostol 800 µg vaginally
2. STAT -hCG levels
3. Laparotomy
4. Decline to perform an abortion,
as the patient has miscarried
Case Study 5
• 30-year-old G1P0
• 12 days status post
mifepristone/misoprostol
• Reports continuous bleeding
since taking misoprostol
• No persistent pain
• Afebrile (temp 98.70 F)
• BP 114/78; HR 74
Treatment options include all
of the following except:
• Hct: 31%
1. Vacuum aspiration
• Ultrasound: widened
2. Trial of methergine, 0.2 mg IM
endometrial stripe (2 cm)
3. Repeat mifepristone
4. Expectant management