Guideline:
Bibliographic Source(s)
- American College of Obstetricians and Gynecologists (ACOG). Premature rupture of membranes. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2007 Apr. 13 p. (ACOG practice bulletin; no. 80). [103 references]
Guideline Status
This is the current release of the guideline.
This guideline updates a previous version: American College of Obstetricians and Gynecologists (ACOG). Premature rupture of membranes. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 1998 Jun. 10 p. (ACOG practice bulletin; no. 1).
Guideline Category
Diagnosis
Evaluation
Management
Prevention
Intended Users
Physicians
Guideline Objective(s)
- To aid practitioners in making decisions about appropriate obstetric and gynecologic care
- To review the current understanding of premature rupture of membranes (PROM) and to provide management guidelines that have been validated by appropriately conducted outcome-based research
Target Population
Pregnant women with suspected premature rupture of membranes
Interventions and Practices Considered
Diagnosis/Evaluation
- History and physical examination including sterile speculum examination and visualization of fluid passing from the cervical canal
- Ultrasound examination of amniotic fluid volume
- Ultrasound-guided transabdominal instillation of indigo carmine dye followed by observation for passage of blue fluid from the vagina
- Assessment of fetal presentation gestational age and well-being
- Fetal heart rate monitoring and uterine activity monitoring to assess fetal status
Management
- Oxytocin for induction of labor (32 to 36 weeks of gestation)
- Expectant management (stable condition and less than 30 to 32 weeks of gestation)
- Ultrasound assessments of amniotic fluid volume and cervical length (not recommended in isolation from other management methods)
- Tocolysis
- Prophylactic or therapeutic antibiotics:
- Intravenous ampicillin and erythromycin followed by oral amoxicillin and erythromycin
- Oral erythromycin and amoxicillin-clavulanic acid (not recommended)
- Antenatal corticosteroids
- Home care
- Cervical cerclage treatment
- Treatment for patients with herpes simplex virus infection
Major Outcomes Considered
- Risk factors associated with premature rupture of membranes (PROM)
- Rate of maternal and fetal complications associated with PROM
- Infant survival rates in pregnancies complicated by PROM
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 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 November 2006. 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 recommendations (A-C) are defined at the end of "Major Recommendations" field.
The following recommendations and conclusions are based on good and consistent scientific evidence (Level A):
- For women with premature rupture of membranes (PROM) at term labor should be induced at the time of presentation generally with oxytocin infusion to reduce the risk of chorioamnionitis.
- Patients with PROM before 32 weeks of gestation should be cared for expectantly until 33 completed weeks of gestation if no maternal or fetal contraindications exist.
- A 48-hour course of intravenous ampicillin and erythromycin followed by 5 days of amoxicillin and erythromycin is recommended during expectant management of preterm PROM remote from term to prolong pregnancy and to reduce infectious and gestational age-dependent neonatal morbidity.
- All women with PROM and a viable fetus including those known to be carriers of group B streptococci and those who give birth before carrier status can be delineated should receive intrapartum chemoprophylaxis to prevent vertical transmission of group B streptococci regardless of earlier treatments.
- A single course of antenatal corticosteroids should be administered to women with PROM before 32 weeks of gestation to reduce the risks of respiratory distress syndrome (RDS) perinatal mortality and other morbidities.
The following recommendations and conclusions are based on limited and inconsistent scientific evidence (Level B):
- Delivery is recommended when PROM occurs at or beyond 34 weeks of gestation.
- With PROM at 32 to 33 completed weeks of gestation labor induction may be considered if fetal pulmonary maturity has been documented.
- Digital cervical examinations should be avoided in patients with PROM unless they are in active labor or imminent delivery is anticipated.
The following recommendations and conclusions are based primarily on consensus and expert opinion (Level C):
- A specific recommendation for or against tocolysis administration cannot be made.
- The efficacy of corticosteroid use at 32–33 completed weeks is unclear based on available evidence but treatment may be beneficial particularly if pulmonary immaturity is documented.
- For a woman with preterm PROM and a viable fetus the safety of expectant management at home has not been established.
Table: Management of Premature Rupture of Membranes Chronologically
| Gestational Age | Management |
|---|---|
| Term (37 weeks or more) |
|
| Near term (34 weeks to 36 completed) |
|
| Preterm (32 weeks to 33 completed weeks) |
|
| Preterm (24 weeks to 31 completed weeks) |
|
| Less than 24 weeks* |
|
*The combination of birthweight gestational age and sex provide the best estimate of chances of survival and should be considered in individual cases.
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 could also 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.
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
Overall Benefits
Improved understanding and management of premature rupture of membranes (PROM)
Potential Harms
Amoxicillin–clavulanic acid should be avoided because of the increased risk of neonatal necrotizing enterocolitis.
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.
Implementation Tools
Audit Criteria/Indicators
For information about availability see the "Availability of Companion Documents" and "Patient Resources" fields below.
IOM Care Need
Getting Better
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness
Timeliness
Bibliographic Source(s)
- American College of Obstetricians and Gynecologists (ACOG). Premature rupture of membranes. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2007 Apr. 13 p. (ACOG practice bulletin; no. 80). [103 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.
This guideline updates a previous version: American College of Obstetricians and Gynecologists (ACOG). Premature rupture of membranes. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 1998 Jun. 10 p. (ACOG practice bulletin; no. 1).
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
Proposed performance measures are included in the original guideline document.
Patient Resources
None available
NGC STATUS
This NGC summary was completed by ECRI on January 14 2005. This NGC summary was updated by ECRI Institute on October 4 2007. The updated information was verified by the guideline developer on December 3 2007.
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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