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# Management of Preterm Labor

*Evidence Reports/Technology Assessments, No. 18*

Investigators: Nancy D Berkman, PhD, Principal Investigator, John M Thorp, Jr, MD, Katherine E Hartmann, MD, PhD, Kathleen N Lohr, PhD, Anjolie E Idicula, BA, Melissa McPheeters, MPH, Norma I Gavin, PhD, Timothy S Carey, MD, Sue Tolleson-Rinehart, PhD, Anne M Jackman, MSW, Victor Hasselblad, PhD, and Emily C Puckett, BA.

Agency for Healthcare Research and Quality (US)2000 Dec

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## Structured Abstract

#### Objectives:

Preterm labor is often a prelude to early births and the                significant attendant burden of infant morbidity and mortality. To address the                question of how best to manage women in preterm labor, the Research Triangle                Institute-University of North Carolina Evidence-based Practice Center undertook a                rigorous review of the scientific literature on: (1) appropriate criteria for                diagnosing preterm labor and use of three biologic markers, fetal fibronectin (fFN),                endovaginal ultrasound (EVUSD), and salivary estriol; (2) efficacy and effectiveness                of tocolytics-pharmaceutical agents including beta-mimetics, calcium channel                blockers, magnesium sulfate, nonsteroidal antiinflammatory disease drugs (NSAIDs),                and ethanol that arrest preterm labor symptoms); (3) efficacy and effectiveness of                antibiotics for treating covert infections that might have prompted preterm labor;                and (4) efficacy of home uterine activity monitoring.

#### Search Strategy:

We conducted a detailed search of the relevant                literature using MEDLINE; EMBASE; the Cochrane Collaboration and its related York                Database, International Pharmaceutical Abstracts; the Health Economic Evaluations                Database; Genderwatch; and the Population Index. The Medical Subject Headings                included premature labor, diagnosis, epidemiologic study characteristics, terms for                specific therapies (biologic markers, antibiotics, and tocolytic agents) and costs,                cost analysis, and cost-benefit analysis. We conducted an extensive search of the                gray literature, chiefly government documents, with a focus on tocolytics and                biologic markers.

#### Selection Criteria:

Our inclusion criteria were randomized controlled                trials (RCTs) and cohort or case-control studies on biologic markers, tocolytics,                and antibiotics that met the following specifications: published from 1966 to 1999                in English, French, or German; including pregnant females of any age with signs and                symptoms of preterm labor; involving inpatient and outpatient settings; and                measuring delivery, maternal morbidities, and infant health outcomes. Home uterine                activity monitoring was further restricted to RCTs published in English since                1980.

#### Data Collection and Analysis:

We conducted dual and blinded reviews of                abstracts of articles and pulled full articles. Those articles meeting inclusion                criteria were given a detailed dual review and abstraction onto four                (topic-specific) data extraction forms. We judged the quality of the individual                articles (on internal validity, statistical considerations, clinical relevance of                findings, an external validity) and the strength of the evidence overall in each                topic area (considering consistency of findings over all studies, quality rating of                each study, magnitude of important outcomes, and meta-analysis results). In addition                to the systematic reviews of the literature, we conducted meta-analyses of treatment                effects from first-line and maintenance tocolytics, antibiotics, and home uterine                activity monitoring.

#### Main Results:

The quality of this literature is questionable in many                respects, including the definition of preterm labor, the size of the trials,                confounding of results because of use of cointerventions, reliance on bivariate                analyses without including stratified analyses such as would be available through                survival analysis, and failure to separately analyze women who have conditions that                culminate in medically indicated preterm births.

Both fFN and EVUSD present strong evidence of effectiveness from cohort studies as                diagnostic tools for assessing the risk of preterm birth in women with preterm                labor, mainly in terms of their negative predictive value. Both can identify women                who are not likely to experience a preterm birth and thus help clinicians avoid                unneeded therapy. The efficacy of these findings from RCTs is not yet available.

First-line treatment with certain tocolytics offers small improvements in pregnancy                prolongation. Whether this prolongation is beneficial in improving neonatal outcomes                has not been established. Tocolytics other than beta-mimetics offer greater efficacy                at less risk; the benefits of beta-mimetics never exceeded other options, and their                harms were potentially more severe than for other options. Ethanol is less                efficacious than other tocolytic options and is an inappropriate treatment for women                with preterm labor symptoms. In terms of gestational age at birth, prolongation of                pregnancy, or birth weight, maintenance treatment with tocolytics conferred no                benefits. Evidence of harms was high for beta-mimetics in relation to the                probability of maternal risk (serious cardiovascular harms, minor cardiovascular                harms, metabolic harms, and psychologic harms); harms for other tocolytics were                regarded as low for maternal risk. All classes of tocolytics posed low short-term                risk for fetal or neonatal outcomes. Long-term risk to the infant was not                evaluated.

Therapy with antibiotics for occult in utero infections believed to be associated                with preterm labor had mixed results, but meta-analysis indicated marginally                significant improvements in two maternal outcomes (length of pregnancy and                gestational age). Significant increases in birth weight were not found.

No RCT of home uterine activity monitoring that controlled for the cointervention of                nursing support found a significant effect from use of this device. Meta-analysis                confirmed this "no- effect" conclusion in relation to gestational age at birth and                birth weight.

#### Conclusions:

Based on the literature reviewed, two biologic markers                (fFN and EVUSD) are found to be quite useful in identifying women in preterm labor                who are at low risk of experiencing a preterm birth. Although the evidence remains                mixed, certain tocolytics-beta- mimetics, calcium channel blockers, magnesium                sulfate, and NSAIDs-appear effective in prolonging pregnancy when used as first-line                agents in arresting preterm labor, but beta- mimetics in comparison with other                tocolytics seem to present a higher risk of maternal harms. Ethanol is not found to                be an appropriate tocolytic agent. Tocolytics are not useful as maintenance                interventions. Antibiotics for suspected genital tract infections may be useful.                Home uterine activity monitoring was found to confer no maternal or fetal/neonatal                benefits.

The literature concerning the management of preterm labor is flawed in several ways                relating largely to definitions of preterm labor, appropriate measures of outcomes,                and use of survival analysis. Epidemiologic research as well as additional efficacy                and effectiveness studies of the two biologic markers, selected tocolytics, and                antibiotics are warranted. 

## Contents

                          - Expand All
                          - Collapse All

                        - Preface
                        - Summary
                        - 1. Introduction                           - Primary Objectives and Scope
                          - Key Clinical Questions
                          - Technical Expert Advisory Group
                          - Background and Significance
                          - Clinical Management of Preterm Labor
                          - Organization of this Report
                        - 2. Methodology                           - Key Questions and Causal Pathways
                          - Literature Search
                          - Literature Retrieval Process
                          - Data Abstraction Process
                          - Quality Control, Adjudication, and Reliability
                          - Quality Rating Development and Analysis
                          - Development of the Evidence Tables
                          - Peer Review Process
                          - Supplemental Analysis
                        - 3. Results                           - Introduction
                          - Issues and Limitations in the Literature
                          - Biologic Markers
                          - Tocolytics
                          - Antibiotics
                          - Home Uterine Activity Monitoring
                        - 4. Meta-Analyses                           - Introduction
                          - Methods
                          - Results
                          - Summary and Conclusions
                        - 5. Conclusions                           - Introduction
                          - Grading the Evidence
                          - Biologic Markers
                          - Tocolytics
                          - Antibiotics
                          - Home Uterine Activity Monitoring
                        - 6. Recommendations for Future Research                           - Definitional and Methods Issues
                          - A Future Research Agenda
                        - Appendixes                           - Appendix A. Acknowledgments
                          - Appendix B. Extraction Forms
                          - Appendix C. Acronyms and Abbreviations
                        - Evidence Tables
                        - References
                        - Bibliography

                          - Expand All
                          - Collapse All

Prepared for: Agency for Healthcare Research and Quality, U.S. Department                of Health and Human Services.1                 Contract No. 290-97-0011.                Prepared by: Research Triangle                    Institute, Research Triangle Park, NC.

#### Suggested citation:

Berkman, ND, Thorp, JM Jr, Hartmann, KE, et al.                    Management of preterm labor. Evidence Report/Technology Assessment No. 18                    (Prepared by Research Triangle Institute under Contract No. 290-97-0011). AHRQ                    Publication No. 01-E021. Rockville (MD) Agency for Healthcare Research and                    Quality. December 2000.

On December 6, 1999, under Public Law 106-129, the Agency for Health Care Policy and                Research (AHCPR) was reauthorized and renamed the Agency for Healthcare Research and                Quality (AHRQ). The law authorizes AHRQ to continue its research on the cost,                quality, and outcomes of health care, and expands its role to improve patient safety                and address medical errors. 

This report may be used, in whole or in part, as the basis for development of                clinical practice guidelines and other quality enhancement tools, or a basis for                reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human                Services endorsement of such derivative products may not be stated or implied.

The authors of this report are responsible for its content. Statements in the report                should not be construed as endorsement by the Agency for Healthcare Research and                Quality or the U.S. Department of Health and Human Services of a particular drug,                device, test, treatment, or other clinical service.

                        - 1
                        - 
2101 East Jefferson Street, Rockville, MD 20852. www​.ahrq.gov

Copyright Notice

Bookshelf ID: NBK33232

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                    - Cite this Page Berkman ND, Thorp JM Jr, Hartmann KE, et al. Management of Preterm Labor. Rockville (MD): Agency for Healthcare Research and Quality (US); 2000 Dec. (Evidence Reports/Technology Assessments, No. 18.)

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