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Terbutaline Pump for the Prevention of Preterm Birth
Comparative Effectiveness Reviews, No. 35
Investigators: Laura Gaudet, MD, Kavita Singh, MPH, Laura Weeks, PhD, Becky Skidmore, MLS, Sophia Tsouros, BH Kin, Alexander Tsertsvadze, MD, MSc, Raymond Daniel, BA, Steve Doucette, MSc, Mark Walker, MD, and Mohammed Ansari, MBBS, MMedSc, MPhil.
Author Information and AffiliationsStructured Abstract
Background:
Tocolytic agents inhibit contractions during the labor process. Subcutaneous terbutaline (SQ terbutaline) infusion by pump is used as a prolonged (beyond 48–72 hours) maintenance tocolytic following acute treatment of preterm contractions. The effectiveness and safety of this maintenance tocolysis have not been clearly established.
Objectives:
To compare the benefits and harms of the SQ terbutaline pump with other tocolytics, conservative management, or placebo in specific populations of women with arrested preterm labor, and to explore confounding by level of maternal activity and care.
Data Sources:
MEDLINE (1950 to April 1, 2011); Embase (1980 to April 1, 2011); CINAHL (1985 to December 7, 2009), the Cochrane Library (April 1, 2011), and the Centre for Reviews and Dissemination databases (January 2, 2010). We also reviewed grey literature.
Review Methods:
We followed a prior systematic review protocol. Two reviewers independently included reports that investigated SQ terbutaline pump therapy in women between 24–36 weeks' gestation following arrest of preterm labor. We included noncomparative studies only for pump-related harms. Non-English records without an English abstract were excluded. We also excluded case reports but sought Food and Drug Administration (FDA) summaries of postmarketing surveillance data. One reviewer extracted data into a standardized electronic form and assessed study risk of bias and applicability. A second reviewer verified data.
Results:
Two randomized trials, one nonrandomized trial, and 11 observational studies met inclusion criteria. In women with recurrent preterm labor (RPTL) and singleton gestation, the strength of evidence favoring the SQ terbutaline pump over oral tocolytics or no treatment is low for the outcomes of incidence of delivery at <32 weeks and <37 weeks, and mean days of pregnancy prolongation. In women with RPTL and twin gestation, the strength of evidence favoring the pump over oral tocolytics is low for neonatal death, incidence of delivery at <32 weeks, and mean days of pregnancy prolongation. Strength of evidence is insufficient for bronchopulmonary dysplasia, incidence of delivery <28 weeks and <34 weeks, and withdrawals due to adverse events. Observational studies of medium to high risk of bias showed the benefit of the SQ terbutaline pump for other surrogate outcomes, such as birth weight and neonatal intensive care unit (NICU) admission. Absent or inconclusive evidence addressed all other neonatal health outcomes, neonatal harms, maternal harms, and pump-related outcomes. An assessment of confounding by maternal activity and maternal care was not possible due to sparse data. Until 2009, several cases of maternal deaths and maternal cardiovascular events in association with terbutaline tocolysis have been reported to the FDA.
Conclusions:
The evidence base consists of a small number of biased studies. A substantial body of evidence originated from one proprietary database. Although evidence suggests that pump therapy is beneficial as maintenance tocolysis, our confidence in its validity and reproducibility is low. While postmarketing surveillance has detected cases of serious harms, safety of the therapy remains unclear.
Contents
EPC Director: David Moher, PhD
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. HHSA 290 2007 10059 I. Prepared by: University of Ottawa Evidence-based Practice Center, Ottawa, Ontario, Canada
Suggested citation:
Gaudet L, Singh K, Weeks L, Skidmore B, Tsouros S, Tsertsvadze A, Daniel R, Doucette S, Walker M, Ansari MT. Terbutaline Pump for the Prevention of Preterm Birth. Comparative Effectiveness Review No. 35. (Prepared by the University of Ottawa Evidence-based Practice Center under Contract No. HHSA290-2007-10059-I.) AHRQ Publication No. 11-EHC068-EF. Rockville, MD: Agency for Healthcare Research and Quality. September 2011. Available at: www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the University of Ottawa Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10059-I). The findings and conclusions in this document are those of the author(s), who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This report is intended as a reference and not as a substitute for clinical judgment.
This report may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products or actions may not be stated or implied.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
- 1
540 Gaither Road, Rockville, MD 20850; www
.ahrq.gov
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