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Therapeutic Management, Delivery, and Postpartum Risk Assessment and Screening in Gestational Diabetes

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Therapeutic Management, Delivery, and Postpartum Risk Assessment and Screening in Gestational Diabetes Evidence Report/Technology Assessment Number 162 Therapeutic Management, Delivery, and Postpartum Risk Assessment and Screening in Gestational Diabetes Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Contract No. 290-02-0018 Prepared by: The Johns Hopkins University Evidence-based Practice Center, Baltimore, MD Investigators Wanda K. Nicholson, M.D., M.P.H., M.B.A. Lisa M. Wilson, Sc.M. Catherine Takacs Witkop, M.D., M.P.H. Kesha Baptiste-Roberts, Ph.D., M.P.H. Wendy L. Bennett, M.D., M.P.H. Shari Bolen, M.D., M.P.H. Bethany B. Barone, Sc.M. Sherita Hill Golden, M.D., M.H.S. Tiffany L. Gary, Ph.D. Donna M. Neale, M.D. Eric B. Bass, M.D., M.P.H. AHRQ Publication No. 08-E004 March 2008 This report is based on research conducted by the Johns Hopkins University Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0018). 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 may not be stated or implied. This document is in the public domain and may be used and reprinted without permission except those copyrighted materials noted for which further reproduction is prohibited without the specific permission of copyright holders. Suggested Citation: Nicholson WK, Wilson LM, Witkop CT, Baptiste-Roberts K, Bennett WL, Bolen S, Barone BB, Golden SH, Gary TL, Neale DM, Bass EB. Therapeutic Management, Delivery, and Postpartum Risk Assessment and Screening in Gestational Diabetes. Evidence Report/Technology Assessment No. 162 (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No. 290-02-0018.) AHRQ Publication No. 08-E004. Rockville, MD: Agency for Healthcare Research and Quality. March 2008. No investigators have any affiliations or financial involvement (e.g., employment, consultancies, honoraria, stock options, expert testimony, grants or patents received or pending, or royalties) that conflict with material presented in this report. ii Preface The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-Based Practice Centers (EPCs), sponsors the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. The reports and assessments provide organizations with comprehensive, science-based information on common, costly medical conditions and new health care technologies. The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments. To bring the broadest range of experts into the development of evidence reports and health technology assessments, AHRQ encourages the EPCs to form partnerships and enter into collaborations with other medical and research organizations. The EPCs work with these partner organizations to ensure that the evidence reports and technology assessments they produce will become building blocks for health care quality improvement projects throughout the Nation. The reports undergo peer review prior to their release. AHRQ expects that the EPC evidence reports and technology assessments will inform individual health plans, providers, and purchasers as well as the health care system as a whole by providing important information to help improve health care quality. We welcome comments on this evidence report. They may be sent by mail to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850, or by e-mail to [email protected]. Carolyn M. Clancy, M.D. Jean Slutsky, P.A., M.S.P.H. Director Director, Center for Outcomes and Evidence Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality Beth A. Collins Sharp, R.N., Ph.D. Shilpa H. Amin, M.D., M.Bsc. Director, EPC Program EPC Program Task Order Officer Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality iii Acknowledgments The Evidence-based Practice Center thanks Gabriel Lai and Haeseong Park for their assistance with article reviewing and data entry; Karen Robinson for her guidance on the search strategy; Allison Jonas for her assistance with final preparations of the report; Deborah McClellan for copy editing; and Renee Wilson and Michael Oladubu for their assistance with the study. We would also like to acknowledge our technical expert panel: E. Albert Reece, M.D., Ph.D., M.B.A. Troy Flint Porter, M.D. Dean & Vice President for Medical Affairs University of Utah School of Medicine and University of Maryland School of Medicine Intermountain Health Care Baltimore, MD Salt Lake City, UT Richard Hellman, M.D. Jean M. Lawrence, Sc.D., M.P.H. Clinical Professor of Medicine Research Scientist II/Epidemiologist University of Missouri – Kansas City School Research and Evaluation of Medicine Kaiser Permanente Southern California Kansas City, MO Pasadena, CA iv Structured Abstract Objectives: We focused on four questions: (1) What are the risks and benefits of an oral diabetes agent (i.e., glyburide), as compared to all types of insulin, for gestational diabetes? (2) What is the evidence that elective labor induction, cesarean delivery, or timing of induction is associated with benefits or harm to the mother and neonate? (3) What risk factors are associated with the development of type 2 diabetes after gestational diabetes? (4) What are the performance characteristics of diagnostic tests for type 2 diabetes in women with gestational diabetes? Data Sources: We searched electronic databases for studies published through January 2007. Additional articles were identified by searching the table of contents of 13 journals for relevant citations from August 2006 to January 2007 and reviewing the references in eligible articles and selected review articles. Review Methods: Paired investigators reviewed abstracts and full articles. We included studies that were written in English, reported on human subjects, contained original data, and evaluated women with appropriately diagnosed gestational diabetes. Paired reviewers performed serial abstraction of data from each eligible study. Study quality was assessed independently by each reviewer. Main Results: The search identified 45 relevant articles. The evidence indicated that (1) maternal glucose levels do not differ substantially in those treated with insulin versus insulin analogues or oral agents; (2) average infant birth weight may be lower in mothers treated with insulin than with glyburide; (3) induction at 38 weeks may reduce the macrosomia rate, with no increase in cesarean delivery rates; (4) anthropometric measures, fasting blood glucose (FBG), and 2-hour glucose value are the strongest risk factors associated with development of type 2 diabetes; (5) FBG had high specificity, but variable sensitivity, when compared to the 75-gm oral glucose tolerance test (OGTT) in the diagnosis of type 2 diabetes after delivery. Conclusions: The evidence suggests that benefits and a low likelihood of harm are associated with the treatment of gestational diabetes with an oral diabetes agent or insulin. The effect of induction or elective cesarean on outcomes is unclear. The evidence is consistent that anthropometry identifies women at risk of developing subsequent type 2 diabetes; however, no evidence suggested the FBG out-performs the 75-gm OGTT in diagnosing type 2 diabetes after delivery. v Contents Executive Summary.........................................................................................................................1 Evidence Report...........................................................................................................................13 Chapter 1. Introduction ..................................................................................................................15 Conceptual Framework and Key Questions ............................................................................17 Chapter 2. Methods........................................................................................................................23 Topic Development..................................................................................................................23 Search Strategy ........................................................................................................................23 Study Selection ........................................................................................................................24 Data Abstraction ......................................................................................................................26
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