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## Complete Summary

#### GUIDELINE TITLE

Emergency contraception.

#### BIBLIOGRAPHIC SOURCE(S)

American College of Obstetricians and Gynecologists (ACOG). Emergency
contraception. Washington (DC): American College of Obstetricians and
Gynecologists (ACOG); 2005 Dec. 10 p. (ACOG practice bulletin; no. 69).
\[86 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Emergency oral contraception.
Washington (DC): American College of Obstetricians and Gynecologists
(ACOG); 2001 Mar. 8 p. (ACOG practice bulletin; no. 25). \[48
references\]

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Unintended pregnancy resulting from unprotected or inadequately
protected sexual intercourse

#### GUIDELINE CATEGORY

Counseling\
Management

#### CLINICAL SPECIALTY

Obstetrics and Gynecology\
Pharmacology

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

-   To aid practitioners in making decisions about appropriate obstetric
    and gynecologic care

-   To present evidence regarding the safety, efficacy, risks, and
    benefits of the use of emergency contraception including
    progestin-only, combined oral contraceptives, and intrauterine
    devices

#### TARGET POPULATION

Women who had unprotected or inadequately protected sexual intercourse
within the previous 120 hours who do not desire pregnancy

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Emergency oral contraception including levonorgestrel-only
    (preference) and combination estrogen-progestin regimen. Refer to
    Table 1 in the original guideline document for detailed information
    on the formulation and dosage of common oral contraceptives used as
    emergency contraception.

2.  Antiemetic agent to be taken 1 hour before the first dose of
    combined estrogen-progestin regimen

3.  Counseling patients regarding effective contraceptive methods at the
    time emergency contraception is prescribed

4.  Offering patients an advance prescription for emergency
    contraception during a routine gynecologic visit

5.  Evaluating patients for pregnancy if menses are delayed by a week or
    more after expected time or if lower abdominal pain or persistent
    irregular bleeding develops.

#### MAJOR OUTCOMES CONSIDERED

Incidence of unintended pregnancy

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

The MEDLINE database, the Cochrane Library, and American College of
Obstetricians and Gynecologists\' (ACOG\'s) own internal resources and
documents were used to conduct a literature search to locate relevant
articles published between January 1985 and January 2005. The search was
restricted to articles published in the English language. Priority was
given to articles reporting results of original research, although
review articles and commentaries also were consulted. Abstracts of
research presented at symposia and scientific conferences were not
considered adequate for inclusion in this document.

Guidelines published by organizations or institutions such as the
National Institutes of Health and the American College of Obstetricians
and Gynecologists were reviewed, and additional studies were located by
reviewing bibliographies of identified articles.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Studies were reviewed and evaluated for quality according to the method
outlined by the U.S. Preventive Services Task Force:

**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

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Analysis of available evidence was given priority in formulating
recommendations. When reliable research was not available, expert
opinions from obstetrician-gynecologists were used. See also the
\"Rating Scheme for the Strength of Recommendations\" field regarding
Grade C recommendations.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Based on the highest level of evidence found in the data,
recommendations are provided and graded according to the following
categories:

**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.

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Practice Bulletins are validated by two internal clinical review panels
composed of practicing obstetrician-gynecologists, generalists and
subspecialists. The final guidelines are also reviewed and approved by
the American College of Obstetricians and Gynecologists (ACOG) Executive
Board.

### 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 on good and consistent
scientific evidence (Level A)***:

-   Emergency contraception should be offered or made available to women
    who have had unprotected or inadequately protected sexual
    intercourse and who do not desire pregnancy.

-   The levonorgestrel-only regimen is more effective and is associated
    with less nausea and vomiting; therefore, if available, it should be
    used in preference to the combined estrogen-progestin regimen.

-   The 1.5-mg levonorgestrel-only regimen can be taken as a single
    dose.

-   The two 0.75-mg doses of the levonorgestrel-only regimen are equally
    effective if taken 12-24 hours apart.

-   To reduce the chance of nausea with the combined estrogen-progestin
    regimen, an antiemetic agent may be taken 1 hour before the first
    emergency contraception dose.

-   Prescription or provision of emergency contraception in advance of
    need can increase availability and use.

***The following recommendations are based on limited or inconsistent
scientific evidence (Level B)***:

-   Treatment with emergency contraception should be initiated as soon
    as possible after unprotected or inadequately protected intercourse
    to maximize efficacy.

-   Emergency contraception should be made available to patients who
    request it up to 120 hours after unprotected intercourse.

-   No clinician examination or pregnancy testing is necessary before
    provision or prescription of emergency contraception.

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

-   No data specifically examine the risk of using hormonal methods of
    emergency contraception among women with contraindications to the
    use of conventional oral contraceptive preparations; nevertheless,
    emergency contraception may be made available to such women.

-   Clinical evaluation is indicated for women who have used emergency
    contraception if menses are delayed by a week or more after the
    expected time or if lower abdominal pain or persistent irregular
    bleeding develops.

-   Information regarding effective contraceptive methods should be made
    available either at the time emergency contraception is prescribed
    or at some convenient time thereafter.

-   Emergency contraception may be used even if the woman has used it
    before, even within the same menstrual cycle.

**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\").

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

**Overall Benefits**

Increasing emergency contraception awareness, knowledge, and access are
important priorities in the effort to reduce the incidence of unintended
pregnancy.

**Specific Benefits**

Estimates based on combined data from two studies show a reduced
relative risk of pregnancy (0.51, 95% confidence interval, 0.31-0.83)
with the levonorgestrel-only regimen.

#### POTENTIAL HARMS

**Adverse Effects of Contraceptive Agents**

-   Short term side effects of emergency contraception include:

    -   Nausea and vomiting

    -   Irregular bleeding

    -   Other side effects including breast tenderness, abdominal pain,
        dizziness, headache, and fatigue

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

Although existing pregnancy is not a contraindication for emergency
contraception use in terms of risk of adverse effects, emergency
contraception is not indicated in women with confirmed pregnancy because
it will have no effect.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   These guidelines should not be construed as dictating an exclusive
    course of treatment or procedure. Variations in practice may be
    warranted based on the needs of the individual patient, resources,
    and limitations unique to the institution or type of practice.

-   Some emergency contraception studies have excluded women with
    specific contraindications to oral contraceptives, but no evidence
    demonstrates that emergency contraception is unsafe for women with
    these contraindications or for those with any particular medical
    conditions.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Staying Healthy

#### IOM DOMAIN

Effectiveness\
Patient-centeredness\
Timeliness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

American College of Obstetricians and Gynecologists (ACOG). Emergency
contraception. Washington (DC): American College of Obstetricians and
Gynecologists (ACOG); 2005 Dec. 10 p. (ACOG practice bulletin; no. 69).
\[86 references\]

#### ADAPTATION

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

#### DATE RELEASED

2001 Mar (revised 2005 Dec)

#### 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.

This guideline updates a previous version: Emergency oral contraception.
Washington (DC): American College of Obstetricians and Gynecologists
(ACOG); 2001 Mar. 8 p. (ACOG practice bulletin; no. 25). \[48
references\]

#### GUIDELINE AVAILABILITY

Electronic copies: None available

Print copies: Available for purchase from the American College of
Obstetricians and Gynecologists (ACOG) Distribution Center, PO Box 4500,
Kearneysville, WV 25430-4500; telephone, 800-762-2264, ext. 192; e-mail:
<sales@acog.org>. The ACOG Bookstore is available online at the [ACOG
Web
site](http://sales.acog.com/acb/stores/1/category.cfm?SID=1&Category_ID=15).

#### 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 NGC summary was updated by ECRI 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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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008