• 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]

This is the current release of the guideline.

Antiphospholipid syndrome during pregnancy and postpartum

Diagnosis
Management
Screening
Treatment

Hematology
Internal Medicine
Obstetrics and Gynecology
Rheumatology

Physicians

• To aid practitioners in making decisions about appropriate obstetric and gynecologic care
• To evaluate the data for diagnosis and treatment of antiphospholipid syndrome

Women with antiphospholipid syndrome during pregnancy and postpartum

Screening/Diagnosis

1. Medical history including screening for clinical conditions associated with antiphospholipid syndrome
2. Standardized enzyme-linked immunosorbent assay (ELISA) testing for anticardiolipin antibodies or lupus anticoagulant
3. Further testing if lupus anticoagulant ELISA is positive

Management

Pregnant Women

1. Frequent prenatal examination
2. Serial ultrasonography
3. Antepartum testing after week 32 of gestation or earlier in cases of fetal growth restriction

Long-term Management

Estrogen-free contraception

Treatment

Pregnant Women

1. Prophylactic low-dose aspirin and heparin
2. Full heparin anticoagulation if previous thrombotic event
3. Postpartum anticoagulation
4. Corticosteroids
5. Intravenous immunoglobulin (IVIG) (not recommended as primary therapy)

• Fetal morbidity and mortality
• Incidence of vascular thrombosis

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

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.

Not stated

Weighting According to a Rating Scheme (Scheme Given)

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.

Review of Published Meta-Analyses
Systematic Review

Not stated

Expert Consensus

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.

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.

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

Internal Peer Review

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.

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.

None provided

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

Appropriate diagnosis and management of antiphospholipid syndrome during pregnancy and postpartum

Not stated

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.

An implementation strategy was not provided.

Living with Illness
Staying Healthy

Effectiveness

• 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]

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

2005 Nov

American College of Obstetricians and Gynecologists - Medical Specialty Society

American College of Obstetricians and Gynecologists (ACOG)

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

Not stated

Not stated

This is the current release of the guideline.

None available

None available

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.

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