Guideline:
Antiphospholipid syndrome
Bibliographic Source(s)
- American College of Obstetricians and Gynecologists (ACOG). Antiphospholipid syndrome. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2005 Nov. 9 p. (ACOG practice bulletin; no. 68). [68 references]
Guideline Status
This is the current release of the guideline.
Guideline Category
Diagnosis
Management
Screening
Treatment
Intended Users
Physicians
Guideline Objective(s)
- To aid practitioners in making decisions about appropriate obstetric and gynecologic care
- To evaluate the data for diagnosis and treatment of antiphospholipid syndrome
Target Population
Women with antiphospholipid syndrome during pregnancy and postpartum
Interventions and Practices Considered
Screening/Diagnosis
- Medical history including screening for clinical conditions associated with antiphospholipid syndrome
- Standardized enzyme-linked immunosorbent assay (ELISA) testing for anticardiolipin antibodies or lupus anticoagulant
- Further testing if lupus anticoagulant ELISA is positive
Management
Pregnant Women
- Frequent prenatal examination
- Serial ultrasonography
- Antepartum testing after week 32 of gestation or earlier in cases of fetal growth restriction
Long-term Management
Estrogen-free contraception
Treatment
Pregnant Women
- Prophylactic low-dose aspirin and heparin
- Full heparin anticoagulation if previous thrombotic event
- Postpartum anticoagulation
- Corticosteroids
- Intravenous immunoglobulin (IVIG) (not recommended as primary therapy)
Major Outcomes Considered
- Fetal morbidity and mortality
- Incidence of vascular thrombosis
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 the American College of Obstetricians and Gynecologists' own internal resources and documents were used to conduct a literature search to locate relevant articles published between January 1985 and June 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 sub-specialists. The final guidelines are also reviewed and approved by the American College of Obstetricians and Gynecologists (ACOG) Executive Board.
Major Recommendations
The grades of evidence (I-III) and levels of recommendation (A-C) are defined at the end of the "Major Recommendations" field.
The following recommendation is based on limited or inconsistent scientific evidence (Level B):
- Testing for antiphospholipid antibodies should be limited to those women with appropriate medical or obstetric histories.
The following recommendations are based primarily on consensus and expert opinion (Level C):
- Women with antiphospholipid syndrome and no thrombotic history should receive prophylactic doses of heparin and low-dose aspirin during pregnancy and the postpartum period (6 to 8 weeks).
- Women with antiphospholipid syndrome and previous history of thrombosis should receive full anticoagulation throughout pregnancy and the postpartum period (6 to 8 weeks).
- Women with antiphospholipid syndrome should be referred to an internist or hematologist for long-term follow-up.
- Women with antiphospholipid syndrome should avoid estrogen-containing oral contraceptives.
- Because of the risk for growth restriction consideration should be given to serial ultrasonographic assessment. Antepartum testing should be considered after 32 weeks of gestation or earlier if there are signs of growth restriction.
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
Type of Evidence supporting the Recommendations
The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").
Potential Benefits
Appropriate diagnosis and management of antiphospholipid syndrome during pregnancy and postpartum
Potential Harms
Not stated
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.
Description of Implementation Strategy
An implementation strategy was not provided.
IOM Care Need
Living with Illness
Staying Healthy
IOM Domain
Effectiveness
Bibliographic Source(s)
- American College of Obstetricians and Gynecologists (ACOG). Antiphospholipid syndrome. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2005 Nov. 9 p. (ACOG practice bulletin; no. 68). [68 references]
Adaptation
Not applicable: The guideline was not adapted from another source.
Source(s) of Funding
American College of Obstetricians and Gynecologists (ACOG)
Guideline Committee
American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins-Obstetrics
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
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.
Availability of Companion Documents
None available
Patient Resources
None available
NGC STATUS
This NGC summary was completed by ECRI Institute on October 8 2007. The information was verified by the guideline developer on December 3 2007. This summary was updated by ECRI Institute on March 14 2008 following the updated FDA advisory on heparin sodium injection.
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This NGC summary is based on the original guideline which is subject to the guideline developer's copyright restrictions.
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