Guideline Summary NGC-9419

Guideline Title
Management of preterm labor.

Bibliographic Source(s)
American C ollege of Obstetricians and Gynecologists (AC OG). Management of preterm labor. Washington (DC ): American C ollege of Obstetricians and Gynecologists (AC OG);
2012 Jun. 10 p. (AC OG practice bulletin; no. 127). [86 references] PubMed

Guideline Status
This is the current release of the guideline.
This guideline updates a previous version: American C ollege of Obstetricians and Gynecologists (AC OG). Management of preterm labor. Washington (DC ): American C ollege of
Obstetricians and Gynecologists (AC OG); 2003 May. 9 p. (AC OG practice bulletin; no. 43). [74 references]

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.
July 9, 2015 - Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDS) : The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning
that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on FDAs comprehensive review of new safety
information, FDA is requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of overthe-counter (OTC ) non-aspirin NSAIDs already contain information on heart attack and stroke risk. FDA will also request updates to the OTC non-aspirin NSAID Drug
Facts labels.

Scope
Disease/Condition(s)
Preterm labor

Guideline Category
Evaluation
Management
Prevention

Clinical Specialty
Emergency Medicine
Obstetrics and Gynecology

Intended Users
Advanced Practice Nurses
Nurses
Physician Assistants
Physicians

Guideline Objective(s)
To present the various methods proposed to manage preterm labor and to review the evidence for the roles of these methods in clinical practice
Note: Identification and m anagem ent of risk factors for preterm labor are not addressed in this docum ent.

Target Population
Women in preterm labor

Interventions and Practices Considered

1.

Tocolytic therapy, including beta-adrenergic agonists; calcium channel blockers; non-steroidal anti-inflammatory drugs (NSAIDs)

2.

Fetal neuroprotection (magnesium sulfate)

3.

Antenatal corticosteroids (dexamethasone, betamethasone)

Note: Bed rest and hydration were considered but not routinely recom m ended. Repeated and m aintenance tocolytic therapies and antibiotics to prolong gestation were also
considered, but not recom m ended as a general practice.

Major Outcomes Considered

Predictive value of tests for risk of preterm birth
Neonatal morbidity and mortality

Maternal and fetal side effects associated with treatment

Effectiveness of tocolytics and antibiotics in prolonging pregnancy or improving neonatal outcomes

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 C ochrane Library, and the American C ollege of Obstetricians and Gynecologists' own internal resources and documents were used to conduct a
literature search to locate relevant articles published between: January 1990 - March 2012. 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 C ollege 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 obstetriciangynecologists 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

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 C onsensus

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 Level 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 C ollege of Obstetricians and Gynecologists (AC OG) Executive Board.

Recommendations
Major Recommendations
The grades of evidence (I-III) and levels of recommendations (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):
A single course of corticosteroids is recommended for pregnant women between 24 weeks of gestation and 34 weeks of gestation who are at risk of preterm delivery
within 7 days.

Accumulated available evidence suggests that magnesium sulfate reduces the severity and risk of cerebral palsy in surviving infants if administered when birth is
anticipated before 32 weeks of gestation. Hospitals that elect to use magnesium sulfate for fetal neuroprotection should develop uniform and specific guidelines for their
departments regarding inclusion criteria, treatment regimens, concurrent tocolysis, and monitoring in accordance with one of the larger trials.
The evidence supports the use of first-line tocolytic treatment with beta-adrenergic agonist therapy, calcium channel blockers, or non-steroidal anti-inflammatory drugs
(NSAIDs) for short-term prolongation of pregnancy (up to 48 hours) to allow for the administration of antenatal steroids.
Maintenance therapy with tocolytics is ineffective for preventing preterm birth and improving neonatal outcomes and is not recommended for this purpose.
Antibiotics should not be used to prolong gestation or improve neonatal outcomes in women with pre-term labor and intact membranes.
The following recommendations and conclusions are based on limited or inconsistent scientific evidence (Level B):
A single course of repeat antenatal corticosteroids should be considered in women whose prior course of antenatal corticosteroids was administered at least 7 days
previously and who remain at risk of preterm birth before 34 weeks of gestation.
Bed rest and hydration have not been shown to be effective for the prevention of preterm birth and should not be routinely recommended.
The positive predictive value of a positive fetal fibronectin test result or a short cervix alone is poor and should not be used exclusively to direct management in the
setting of acute symptoms.
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.

Clinical Algorithm(s)
None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations
The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits
Safe and effective management of women with preterm labor

Potential Harms
Common Tocolytic Agents
Calcium Channel Blockers
Maternal side effects: Dizziness, flushing, and hypotension; suppression of heart rate, contractility, and left ventricular systolic pressure when used with magnesium
sulfate; and elevation of hepatic transaminases
Fetal or newborn adverse effects: No known adverse effects
Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Maternal side effects: Nausea, esophageal reflux, gastritis, and emesis; platelet dysfunction is rarely of clinical significance in patients without underlying bleeding
disorder
Fetal or newborn adverse effects: In utero constriction of ductus arteriosus*, oligohydramnios*, necrotizing enterocolitis in preterm newborns, and patent ductus
arteriosus in newborn
*Greatest risk associated with use for longer than 48 hours
Data are conflicting regarding this association

Beta-adrenergic Receptor Agonists

Maternal side effects: Tachycardia, hypotension, tremor, palpitations, shortness of breath, chest discomfort, pulmonary edema, hypokalemia, and hyperglycemia
Fetal or newborn adverse effects: Fetal tachycardia
Magnesium Sulfate
Maternal side effects: C auses flushing, diaphoresis, nausea, loss of deep tendon reflexes, respiratory depression, and cardiac arrest; suppresses heart rate, contractility
and left ventricular systolic pressure when used with calcium channel blockers; and produces neuromuscular blockade when used with calcium-channel blockers.
Fetal or newborn adverse effects: Neonatal depression (The use of magnesium sulfate in doses and duration for fetal neuroprotection alone does not appear to be
associated with an increased risk of neonatal depression when correlated with cord blood magnesium levels.)

Contraindications
Contraindications
C alcium channel blockers - Hypotension and preload-dependent cardiac lesions, such as aortic insufficiency

Non-steroidal Anti-inflammatory Drugs (NSAIDs) - Platelet dysfunction or bleeding disorder, hepatic dysfunction, gastrointestinal ulcerative disease, renal dysfunction, and
asthma (in women with hypersensitivity to aspirin)
Beta-adrenergic receptor agonists - Tachycardia-sensitive maternal cardiac disease and poorly controlled diabetes mellitus
Magnesium sulfate - Myasthenia gravis
Tocolysis
Intrauterine fetal demise
Lethal fetal anomaly
Nonreassuring fetal status
Severe preeclampsia or eclampsia
Maternal bleeding with hemodynamic instability
C horioamnionitis
Preterm premature rupture of membranes*
Maternal contraindications to tocolysis (agent specific)
*In the absence of m aternal infection, tocolytics m ay be considered for the purposes of m aternal transport, steroid adm inistration, or both.

Qualifying Statements
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 C riteria/Indicators
C hart Documentation/C hecklists/Forms
Patient Resources
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

Identifying Information and Availability

Bibliographic Source(s)
American C ollege of Obstetricians and Gynecologists (AC OG). Management of preterm labor. Washington (DC ): American C ollege of Obstetricians and Gynecologists (AC OG);
2012 Jun. 10 p. (AC OG practice bulletin; no. 127). [86 references] PubMed

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

Date Released
2003 May (revised 2012 Jun)

Guideline Developer(s)
American C ollege of Obstetricians and Gynecologists - Medical Specialty Society

Source(s) of Funding
American C ollege of Obstetricians and Gynecologists (AC OG)

Guideline Committee
American C ollege of Obstetricians and Gynecologists (AC OG) C ommittee on Practice Bulletins Obstetrics

Composition of Group That Authored the Guideline

American C ollege of Obstetricians and Gynecologists (AC OG) 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.
This guideline updates a previous version: American C ollege of Obstetricians and Gynecologists (AC OG). Management of preterm labor. Washington (DC ): American C ollege of
Obstetricians and Gynecologists (AC OG); 2003 May. 9 p. (AC OG practice bulletin; no. 43). [74 references]

Guideline Availability
Electronic copies: None available
Print copies: Available for purchase from the American C ollege of Obstetricians and Gynecologists (AC OG) Distribution C enter, PO Box 933104, Atlanta, GA 31193-3104;
telephone, 800-762-2264, ext. 192; e-mail: sales@acog.org. The AC OG Bookstore is available online at the AC OG Web site .

Availability of Companion Documents

The following is available:
Magnesium sulfate before anticipated preterm birth for neuroprotection. Patient safety checklist. Atlanta (GA): American C ollege of Obstetricians and Gynecologists
(AC OG); 2012 Aug. 2 p. Electronic copies: Available in Portable Document Format (PDF) from the American C ollege of Obstetricians and Gynecologists (AC OG) Web site
.
In addition, a proposed performance measure is included in the original guideline document.

Patient Resources
The following is available:
Frequently asked questions: Preterm Labor Atlanta (GA): American C ollege of Obstetricians and Gynecologists (AC OG); 2011 May. 3 p. Electronic copies: Available in
Portable Document Format (PDF) from the American C ollege of Obstetricians and Gynecologists (AC OG) Web site .
Please note: This patient inform ation is intended to provide health professionals with inform ation to share with their patients to help them better understand their health and their
diagnosed disorders. By providing access to this patient inform ation, it is not the intention of NGC to provide specific m edical advice for particular patients. Rather we urge patients
and their representatives to review this m aterial and then to consult with a licensed health professional for evaluation of treatm ent options suitable for them as well as for diagnosis
and answers to their personal m edical questions. This patient inform ation has been derived and prepared from a guideline for health care professionals included on NGC by the
authors or publishers of that original guideline. The patient inform ation is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status
This summary was completed by EC RI on February 4, 2004. The information was verified by the guideline developer on July 26, 2004. The information was reaffirmed by the
guideline developer in 2008 and updated by EC RI Institute on February 9, 2010. This summary was updated by EC RI Institute on March 11, 2011 following the U.S. Food and
Drug Administration (FDA) advisory on Terbutaline. This NGC summary was updated by EC RI Institute on January 21, 2013. This summary was updated by EC RI Institute on July
12, 2013 following the U.S. Food and Drug Administration advisory on Magnesium Sulfate. This summary was updated by EC RI Institute on September 18, 2015 following the U.S.
Food and Drug Administration advisory on non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs).

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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