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Brief Summary

GUIDELINE TITLE

Medical management of abortion.

BIBLIOGRAPHIC SOURCE(S)

  • American College of Obstetricians and Gynecologists (ACOG). Medical management of abortion. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2005 Oct. 12 p. (ACOG practice bulletin; no. 67). [79 references]

GUIDELINE STATUS

This is the current release of the guideline.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

The grades of evidence (I-III) and levels of recommendations (A-C) are defined at the end of "Major Recommendations" field.

The following recommendations are based primarily on good and consistent scientific evidence (Level A):

  • Medical abortion should be considered a medically acceptable alternative to surgical abortion in selected, carefully counseled, and informed women.
  • The U.S. Food and Drug Administration (FDA)-approved protocol of 600 milligrams of mifepristone orally followed approximately 48 hours later by 400 micrograms of misoprostol orally is safe and effective for medical abortion through 49 days of gestation (calculated from the first day of the last menstrual period [LMP]).
  • Compared with the FDA-approved regimen, mifepristone-misoprostol regimens using 200 milligrams of mifepristone orally and 800 micrograms of misoprostol vaginally are associated with a decreased rate of continuing pregnancies, decreased time to expulsion, fewer side effects, improved complete abortion rates, and lower cost for women with pregnancies up to 63 days of gestation based on last menstrual period.
  • A methotrexate-misoprostol regimen is appropriate for medical abortion only in pregnancies up to 49 days of gestation. Women using this regimen may wait up to 4 weeks for complete abortion to occur.
  • Mifepristone-misoprostol regimens using 200 milligrams of mifepristone orally and 800 micrograms of misoprostol vaginally are generally preferred to regimens using methotrexate and misoprostol or misoprostol only for medical abortion.
  • A patient can administer misoprostol safely and effectively, orally or vaginally, in her home as part of a medical abortion regimen.

The following recommendations are based primarily on limited scientific evidence (Level B):

  • Because teratogenicity of medical abortifacients becomes an important issue if the pregnancy continues, patients must be informed of the need for a surgical abortion in the event of a failed abortion.
  • Gestational age should be confirmed by clinical evaluation or ultrasonography

The following recommendations are based primarily on consensus and expert opinion (Level C):

  • Surgical curettage must be available on a 24-hour basis for cases of hemorrhage, even though less than 1% of women having a medical abortion will need a curettage because of excessive bleeding.
  • Pretreatment anti-D immune globulin should be administered if indicated.
  • No data exist to support the universal use of prophylactic antibiotics for medical abortion.

Definitions:

Grades of Evidence

I Evidence obtained from at least one properly designed randomized controlled trial

II-1 Evidence obtained from well-designed controlled trials without randomization

II-2 Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group

II-3 Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments also could be regarded as this type of evidence.

III Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees

Levels of Recommendation

Level A - Recommendations are based on good and consistent scientific evidence.

Level B - Recommendations are based on limited or inconsistent scientific evidence.

Level C - Recommendations are based primarily on consensus and expert opinion.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • American College of Obstetricians and Gynecologists (ACOG). Medical management of abortion. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2005 Oct. 12 p. (ACOG practice bulletin; no. 67). [79 references]

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2001 Apr (revised 2005 Oct)

GUIDELINE DEVELOPER(S)

American College of Obstetricians and Gynecologists - Medical Specialty Society

SOURCE(S) OF FUNDING

American College of Obstetricians and Gynecologists (ACOG)

GUIDELINE COMMITTEE

American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins-Gynecology

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Not stated

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

None available

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on September 22, 2004. The information was verified by the guideline developer on December 9, 2004. This summary was updated by ECRI on July 21, 2005 following the Food and Drug Administration (FDA) advisory on Mifeprex (mifepristone). This summary was updated by ECRI on March 7, 2006 following the updated FDA advisory on Mifeprex (mifepristone). This summary was updated most recently on April 20, 2006.

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

DISCLAIMER

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