Bibliographic Source(s)
| American College of Obstetricians and Gynecologists (ACOG). Cervical insufficiency. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2003 Nov. 9 p. (ACOG practice bulletin; no. 48). [56 references] |
Guideline Status
This is the current release of the guideline.
The American College of Obstetricians and Gynecologists (ACOG) reaffirmed the currency of the guideline in 2008.
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FDA Warning/Regulatory Alert
Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.
- February 17, 2011 – Brethaire, Brethine, Bricanyl (terbutaline sulfate)
 : The U.S. Food and Drug Administration (FDA) notified healthcare professionals that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death. In addition, oral terbutaline should not be used for prevention or any treatment of preterm labor because it has not been shown to be effective and has similar safety concerns. FDA is requiring the addition of a new Boxed Warning and Contraindication to the terbutaline drug labels to warn healthcare professionals about these risks.
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Guideline Category
Management
Screening
Clinical Specialty
Obstetrics and Gynecology
Surgery
Intended Users
Physicians
Guideline Objective(s)
- To aid practitioners in making decisions about appropriate obstetric and gynecologic care
- To provide a review of current evidence on cervical insufficiency, including screening of asymptomatic at-risk women, and offer management guidelines
Target Population
Pregnant women with cervical insufficiency
Interventions and Practices Considered
Diagnosis/Evaluation/Screening
- Patient history, including history of diethylstilbestrol exposure
- Ultrasonography (routine ultrasound screening not recommended)
- Patient selection for cerclage based on history of cervical insufficiency
Management/Treatment
- Frequent examination
- Counseling
- Cerclage (Shirodkar and McDonald procedures, transabdominal cervicoisthmic cerclage)
- Perioperative antibiotics and tocolytics, with caution
Major Outcomes Considered
- Sensitivity and specificity of ultrasound screening of the cervix
- Duration of gestation
- Neonatal morbidity and mortality
- Rate of bacterial infection
- Incidence of complications with cerclage placement
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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' own internal resources and documents were used to conduct a literature search to locate relevant articles published between January 1985 and July 2003. 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.
2008 Reaffirmation
For reaffirmation of a current Practice Bulletin, MEDLINE and Cochrane are searched for new literature. At the discretion of the review committee, additional databases may be searched for particular topics as warranted. In addition, committee members identify relevant literature for review.
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.
2008 Reaffirmation
Each American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin is reviewed every 18-24 months by a member of the Practice Bulletins Committee. The reviewer presents the practice bulletin and any new literature at a full committee hearing. The committee then reaches a consensus on whether to reaffirm or withdraw the practice bulletin.
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.
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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 are based on limited or inconsistent scientific evidence (Level B):
- Serial assessments in low-risk women to screen for cervical insufficiency are of low yield and should not be done routinely.
- Serial ultrasound examinations should be considered in a patient with historical risk factors for cervical insufficiency and should be initiated between 16 and 20 weeks of gestation or later.
- An elective cerclage can be considered in a patient with a history of 3 or more unexplained midtrimester pregnancy losses or preterm deliveries.
- Women exposed to diethylstilbestrol (DES) in utero may be evaluated for cervical insufficiency using the same clinical criteria as nonexposed individuals.
The following recommendations are based primarily on consensus and expert opinion (Level C):
- The evaluation of a patient with cervical shortening or funneling should include a comprehensive ultrasonographic assessment of the fetus to rule out anomalies, as well as physical and laboratory assessments to rule out labor and chorioamnionitis.
- Given the advances in neonatal care and the potential maternal and fetal morbidity associated with cerclage, surgical correction of cervical insufficiency should be limited to pregnancies before fetal viability has been achieved.
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.
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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").
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Benefits/Harms of Implementing the Guideline Recommendations
Potential Benefits
Appropriate screening and management of cervical insufficiency
Potential Harms
The use of unnecessary antibiotics may lead to the development of resistant strains of bacteria and other morbidity for the woman and her fetus.
Cerclage
- Rupture of membranes, chorioamnionitis, and suture displacement are the most common complications associated with cerclage placement, and their incidence varies widely in relation to the timing and indications for the cerclage.
- Urgent and emergency cerclages are associated with a higher incidence of morbidity as a result of cervical shortening and exposure of the fetal membranes to the vaginal ecosystem.
- Transabdominal cerclage can be complicated by rupture of membranes and chorioamnionitis. It carries the added risk of intraoperative hemorrhage from the uterine veins when the cerclage band is tunneled between the bifurcation of the uterine artery, as well as the known risks associated with laparotomy.
- Life-threatening complications of uterine rupture and maternal septicemia are extremely rare but have been reported with all types of cerclage.
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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.
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Implementation of the Guideline
Description of Implementation Strategy
An implementation strategy was not provided.
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Institute of Medicine (IOM) National Healthcare Quality Report Categories
IOM Care Need
Getting Better
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness
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Identifying Information and Availability
Bibliographic Source(s)
| American College of Obstetricians and Gynecologists (ACOG). Cervical insufficiency. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2003 Nov. 9 p. (ACOG practice bulletin; no. 48). [56 references] |
Adaptation
Not applicable: The guideline was not adapted from another source.
Date Released
2003 Nov (reaffirmed 2008)
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.
The American College of Obstetricians and Gynecologists (ACOG) reaffirmed the currency of the guideline in 2008.
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
NGC Status
This NGC summary was completed by ECRI Institute on October 12, 2007. The information was verified by the guideline developer on December 3, 2007. The information was reaffirmed by the guideline developer in 2008 and updated by ECRI Institute on February 9, 2010. This summary was updated by ECRI Institute on March 11, 2011 following the U.S. Food and Drug Administration (FDA) advisory on Terbutaline.
Copyright Statement
This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.
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