Bibliographic Source(s)
| American College of Obstetricians and Gynecologists (ACOG). Fetal lung maturity. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2008 Sep. 10 p. (ACOG practice bulletin; no. 97). [44 references] |
Guideline Status
This is the current release of the guideline.
UMLS Concepts ( what's this?)
Click to view all guideline(s) indexed with these concepts
ICD9CM:
Diabetes mellitus of mother, complicating pregnancy, childbirth, or the puerperium, unspecified as to episode of care (648.00); Diabetes mellitus, antepartum (648.03); Diagnostic amniocentesis (75.1); Respiratory distress syndrome in newborn (769)
MSH:
Amniocentesis; Chromatography, Thin Layer; Diabetes, Gestational; Diseases in Twins; Fetal Organ Maturity; Fluorescence Polarization; Gestational Age; Immunoassay; Infant, Premature; Predictive Value of Tests; Pregnancy; Pregnancy in Diabetics; Prenatal Diagnosis; Respiratory Distress Syndrome, Newborn; Specimen Handling
MTH:
Amniotic fluid L/S ratio measurement; Gestational Age; Gestational Diabetes; Immunoassay method; Infant, Premature; Pregnancy; Pregnancy in Diabetics; Respiratory Distress Syndrome, Newborn; Specimen processing (procedure); Thin Layer Chromatography
SNOMEDCT:
Amniocentesis (265635006); Amniocentesis (34536000); Amniotic fluid lecithin/sphingomyelin ratio (68297005); Amniotic fluid pulmonary surfactant test (359891008); Diabetes mellitus in mother complicating pregnancy, childbirth AND/OR puerperium (199223000); Diabetes mellitus in mother complicating pregnancy, childbirth AND/OR puerperium (76751001); Fetal gestational age (57036006); Foam stability test (359883004); Foam stability test (359885006); Gestational diabetes mellitus (11687002); Immunoassay method (414464004); Lamellated granule, as in surfactant-secreting cell (4548009); Measurement of phosphatidylglycerol antibody (117928000); Optical density measurement (121826005); Pregnancy (289908002); Premature infant (395507008); Pulmonary surfactant test (359888008); Respiratory distress syndrome in the newborn (46775006); Specimen processing (9265001)
UMD:
Amniocentesis Kits (15-274); Analyzers, Laboratory, Hematology, Cell Counting, Automated (17-741); Needles, Biopsy, Amniocentesis (20-239); Reagents, Chromatography, Thin-Layer (17-046); Reagents, Clinical Chemistry, Lipid, Lecithin/Sphingomyelin Ratio (18-915); Spectrophotometers (15-601)
Hide...
|
Disease/Condition(s)
- Fetal lung maturity
- Neonatal respiratory distress syndrome (RDS)
- Pregnancy
Guideline Category
Counseling
Diagnosis
Evaluation
Management
Prevention
Risk Assessment
Clinical Specialty
Obstetrics and Gynecology
Pediatrics
Intended Users
Physicians
Guideline Objective(s)
- To aid practitioners in making decisions about appropriate obstetric and gynecologic care
- To review commonly used tests to determine fetal lung maturity
Target Population
Pregnant women, including those with pregestational and gestational diabetes mellitus
Interventions and Practices Considered
- Tests and techniques to assess fetal lung maturity:
- Fluorescence polarization with TDx-FLM II
- Lecithin/sphingomyelin ratio using thin layer chromatography
- Phosphatidyl-glycerol using thin layer chromatography or antisera with AminoStat-FLM
- Lamellar body counts using commercial hematology counter
- Optical density at 650nm (spectrophotometric reading)
- Foam stability index (ethanol added to amniotic fluid, solution shaken, presence of stable bubble at the meniscus noted)
- Amniocentesis of both twins versus one twin for twin gestations
- Corticosteroid administration
- Use of both gestational age and results of fetal lung maturity testing to predict probability of respiratory distress syndrome
- Use of amniotic fluid collected vaginally versus fluid collected by transabdominal amniocentesis
- Interpretation of test results in pregnant women with diabetes
Major Outcomes Considered
- Sensitivity and specificity of tests for assessment of fetal lung maturity
- Predictive value and utility of fetal lung maturity testing for neonatal respiratory distress syndrome (RDS)
- Complications of amniocentesis
|
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 October 2007. 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
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
Systematic Review
Description of the Methods Used to Analyze the Evidence
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 recommendations (A-C) are defined at the end of "Major Recommendations" field.
The following recommendations and conclusions are based on limited or inconsistent scientific evidence (Level B):
- Testing for fetal lung maturity should not be performed, and is contraindicated, when delivery is mandated for fetal or maternal indications.
- Fetal pulmonary maturity should be confirmed before scheduled delivery at less than 39 weeks of gestation unless fetal maturity can be inferred from historic criteria.
- The probability of neonatal respiratory distress syndrome (RDS) is dependent on both the fetal lung maturity test result and the gestational age at which the fetal lung maturity test was performed.
- Fluorescence polarization assays (TDx FLM II) using a defined mature profile of 55 mg/g or greater is appropriate for the determination of risk of neonatal RDS in pregnancies of women with diabetes mellitus.
- Fetal lung maturity test results from amniotic fluid collected vaginally compared with those from fluid collected by transabdominal amniocentesis demonstrate that when results from fluid collected vaginally are mature, the results are reliable.
- Complications from third-trimester amniocentesis for fetal lung maturity are uncommon when performed with ultrasound guidance.
The following conclusions are based primarily on consensus and expert opinion (Level C):
- In general, the same threshold values for fetal lung maturity tests that predict low risk of neonatal RDS in pregnancies of women who do not have diabetes mellitus apply to pregnancies of women who have diabetes mellitus, whether it is gestational diabetes mellitus or pregestational diabetes mellitus.
- Data suggest that amniocentesis of both twins be performed when the gestation is between 30 0/7 weeks and 32 6/7 weeks of gestation. Amniocentesis of one twin appears to be sufficient when gestation is greater than 32 6/7 weeks.
- Prior to elective delivery, fetal lung maturity testing in twins with well defined gestational ages at 38 0/7 weeks or greater may not be necessary.
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 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.
|
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
The status of fetal lung maturation can assist the clinician in determining when delivery should occur.
Potential Harms
Complications for third semester amniocentesis in one reported study were isolated events but included fetal heart rate abnormalities, placental bleeding, placental abruption, and uterine rupture.
|
Contraindications
Testing for fetal lung maturity should not be performed, and is contraindicated, when delivery is mandated for fetal or maternal indications.
|
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.
|
Implementation of the Guideline
Description of Implementation Strategy
An implementation strategy was not provided.
Implementation Tools
Audit Criteria/IndicatorsFor 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
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness
Timeliness
|
Identifying Information and Availability
Bibliographic Source(s)
| American College of Obstetricians and Gynecologists (ACOG). Fetal lung maturity. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2008 Sep. 10 p. (ACOG practice bulletin; no. 97). [44 references] |
Adaptation
Not applicable: The guideline was not adapted from another source.
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
Financial Disclosures/Conflicts of Interest
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  .
Availability of Companion Documents
Proposed performance measures are included in the original guideline document.
NGC Status
This NGC summary was completed by ECRI Institute on January 5, 2008. The information was verified by the guideline developer on January 23, 2009.
Copyright Statement
This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.
|
NGC Disclaimer
The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site. Read full disclaimer...The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.
All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities.
Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusion-criteria.aspx.
NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.
Readers with questions regarding guideline content are directed to contact the guideline developer. Hide...
|
