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Guideline Summary
Guideline Title
Management of stillbirth.
Bibliographic Source(s)
American College of Obstetricians and Gynecologists (ACOG). Management of stillbirth. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2009 Mar. 14 p. (ACOG practice bulletin; no. 102).  [73 references]
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)
  • Stillbirth
  • Pregnancy
Guideline Category
Counseling
Diagnosis
Evaluation
Management
Prevention
Risk Assessment
Clinical Specialty
Obstetrics and Gynecology
Intended Users
Physicians
Guideline Objective(s)
  • To aid practitioners in making decisions about appropriate obstetric and gynecologic care
  • To review the current information on stillbirth, including definitions and management, the evaluation of a stillbirth, and strategies for prevention
Target Population

Pregnant women

Interventions and Practices Considered
  1. Risk factors associated with stillbirth and subsequent stillbirth
  2. Tests to evaluate a stillbirth
    • Fetal autopsy
    • Examination of the placenta, cord, and membranes
    • Karyotype evaluation
    • Maternal evaluation
  3. Methods of delivery
    • In the second trimester, dilation and evacuation
    • Labor induction at later gestational ages
    • Before 28 weeks of gestation, vaginal misoprostol 
    • Cesarean delivery for fetal demise (reserved only for unusual circumstances)
    • After 28 weeks of gestation, cervical ripening with a transcervical Foley catheter in patients with an unfavorable cervical examination
  4. Patient support including emotional support and clear communication of test results
Major Outcomes Considered
  • Stillbirth rate
  • Recurrent stillbirth rate
  • Percentage of stillbirths for which placental evaluation was performed and autopsy was offered

Methodology

Methods Used to Collect/Select the 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' (ACOG's) own internal resources and documents were used to conduct a literature search to locate relevant articles published between January 1985 and April 2008. 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. When reliable research was not available, expert opinions from obstetrician–gynecologists were used.

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

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
Systematic Review
Description of the Methods Used to Analyze the Evidence

Studies were reviewed and evaluated for quality according to the method outlined by the U.S. Preventive Services Task Force (see "Rating Scheme for the Strength of the Evidence"). Based on the highest level of evidence found in the data, recommendations are provided and graded according to the categories described in "Rating Scheme for the Strength of the Recommendations".

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

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

The Wisconsin Stillbirth Service program estimated that the real cost of a stillbirth assessment was approximately $1,450 in 2001. The most significant information gained was a change in the estimated risk of recurrent stillbirth (42% of cases). Other consequences were a change in the recommendations for subsequent pregnancies with respect to prenatal diagnosis (in 22%) and preconception management (in 1%).

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.

Recommendations

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 recommendations and conclusions are based on good and consistent scientific evidence (Level A):

  • In low-risk women with unexplained stillbirth the risk of recurrence stillbirth after 20 weeks of gestation is estimated at 7.8–10.5/1,000 with most of this risk occurring before 37 weeks of gestation.
  • The most prevalent risk factors associated with stillbirth are non-Hispanic black race, nulliparity, advanced maternal age, and obesity (Table 1 in the original guideline document).
  • The risk of subsequent stillbirth is twice as high for women with a prior live born, growth restricted infant delivered before 32 weeks of gestation than for women with a prior stillbirth.
  • Amniocentesis for fetal karyotyping has the highest yield and is particularly valuable if delivery is not expected imminently.

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

  • In the second trimester, dilation and evacuation can be offered. Labor induction also is appropriate at later gestational ages, if second trimester dilation and evacuation is unavailable, or based on patient preference.
  • Induction of labor with vaginal misoprostol is safe and effective in patients with a prior cesarean delivery with a low transverse uterine scar before 28 weeks of gestation.

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

  • The most important tests in the evaluation of a stillbirth are fetal autopsy; examination of the placenta, cord, and membranes; and karyotype evaluation.
  • Patient support should include emotional support and clear communication of test results. Referral to a bereavement counselor, religious leader, peer support group, or mental health professional may be advisable for management of grief and depression.

Definitions:

Levels 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.

Grades 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)

An algorithm is provided in the original guideline document for fetal and placental evaluation.

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

Appropriate management and evaluation of stillbirth

Potential Harms
  • In patients with a history of stillbirth, antepartum testing may be initiated at 32–34 weeks of gestation. However, this approach is associated with potential morbidity and cost: rates of delivery for abnormal or equivocal testing were 16.3% at or before 39 weeks of gestation and 1% before 36 weeks of gestation. Similarly, the authors of one study estimate that antenatal testing before 37 weeks of gestation results in a 1.5% rate of iatrogenic prematurity for intervention based on false-positive test results. The excess risk of infant mortality due to late preterm birth is 8.8/1,000 at 32–33 weeks of gestation and 3/1,000 at 34–36 weeks of gestation, and this must be considered in any strategy that may lead to iatrogenic late preterm birth.
  • The decision to proceed with early delivery to prevent stillbirth must incorporate an understanding of the increased risks of maternal and neonatal complications compared with the potential benefits. Deliveries before 39 weeks of gestation are associated with an increased risk of admission to neonatal special care units for respiratory complications and other neonatal morbidities.

Qualifying Statements

Qualifying Statements

The information is designed to aid practitioners in making decisions about appropriate obstetric and gynecologic care. 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.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Audit Criteria/Indicators
Clinical Algorithm
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness
Safety

Identifying Information and Availability

Bibliographic Source(s)
American College of Obstetricians and Gynecologists (ACOG). Management of stillbirth. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2009 Mar. 14 p. (ACOG practice bulletin; no. 102).  [73 references]
Adaptation

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

Date Released
2009 Mar
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 - Obstetrics

Composition of Group That Authored the Guideline

ACOG committees are created or abolished and their overall function defined by the Executive Board. Appointments are made for one year, with the understanding that such appointment may be continued for a total of three years. The majority of committee members are Fellows, but Junior Fellows also are eligible for appointment. Some committees may have representatives from other organizations when this is particularly appropriate to committee activities. The president elect appoints committee members annually.

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 933104, Atlanta, GA 31193-3104; telephone, 800-762-2264, ext. 192; e-mail: sales@acog.org. The ACOG Bookstore is available online at the ACOG Web site External Web Site Policy.

Availability of Companion Documents

Proposed performance measures are included in the original guideline document.

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on August 19, 2009. The information was verified by the guideline developer on September 11, 2009.

Copyright Statement

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

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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