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The National Institute of Child Health and Human Development Maternal-Fetal Medicine Unit Network Randomized Clinical Trial in P ORIGINAL ARTICLE The National Institute of Child Health and Human Development Maternal-Fetal Medicine Unit Network Randomized Clinical Trial in Progress Standard therapy versus no therapy for mild gestational diabetes 1 5 MARK B. LANDON, MD GARLAND ANDERSON, MD stillbirth rate for GDM pregnancies that 2 ELIZABETH THOM, PHD FOR THE MATERNAL-FETAL MEDICINE would qualify as preexisting diabetes ac- 3 CATHERINE Y. SPONG, MD UNITS NETWORK,THE NATIONAL 4 cording to World Health Organization MARSHALL CARPENTER, MD INSTITUTE OF CHILD HEALTH AND 2 criteria (6–9). Below this threshold, the LISA MELE, MS UMAN EVELOPMENT ETHESDA 1 H D ,B , extent to which untreated GDM is accom- FRANCEE JOHNSON, RN ARYLAND 4 M * panied by excess perinatal mortality is un- JOANN TILLINGHAST, RN certain. GDM, if untreated or not recognized, may also be associated with an increased t is recognized that women with gesta- apy and insulin as required versus those risk of several morbidities such as macro- tional diabetes mellitus (GDM) who randomized to no specific treatment. somia, birth trauma, neonatal hypoglyce- I have significantly elevated fasting This study aims to clarify whether there mia, hyperbilirubinemia, hypocalcemia, blood glucose levels are at increased is utility in identifying and treating polycythemia, and respiratory distress risk for fetal macrosomia and perinatal women with a normal fasting glucose syndrome (7). The association of GDM morbidity if treatment is not provided level who meet standard criteria for with accelerated fetal growth resulting in (1,2). The association of milder forms of GDM. We plan to compare perinatal large infants at risk for birth trauma and GDM with perinatal morbidity and outcomes in women who have been ran- long-term metabolic effects of obesity has mortality remains unclear, primarily domized to diet and/or insulin therapy received the most clinical attention. How- because the condition is often con- with women who have been random- ever, the attributable risk of GDM for ex- founded with other risk factors such as ized to no specific treatment. A random- maternal obesity, age, and parity. ized treatment trial of mild GDM will cessive fetal growth is not entirely clear Screening for GDM is recommended for clarify whether identification and treat- (10–12). Race, parity, BMI, and maternal most pregnant women, yet it is un- ment of mild GDM reduce perinatal weight gain have all been associated with known whether there is a benefit to the morbidity. This information will assist an increased risk of macrosomia (13). identification and treatment of mild car- in determining appropriate thresholds Sacks et al. (13) reported that only a weak bohydrate intolerance during preg- for the treatment of GDM. relationship exists between maternal glu- nancy (3,4). The present report is an cose levels and birth weight centiles, after update of our previous description of a BACKGROUND AND STUDY controlling for confounding variables. current ongoing randomized treatment RATIONALE — Overall, with broader Similarly, Casey et al. (12) found that only trial for mild GDM (5). A randomized identification and aggressive treatment, 12% of the excess risk for macrosomia in clinical trial of women with mild GDM perinatal mortality rates associated with their GDM population could be attrib- (fasting glucose Ͻ95 mg/dl) is being GDM appear to be similar to the nondia- uted to maternal carbohydrate intoler- undertaken that compares perinatal betic population (1). Several analyses of ance. The relationship between other outcomes in those receiving diet ther- 20 years ago did document an increased morbidities such as neonatal hypoglyce- mia and hyperbilirubinemia with mater- ●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●●● nal glucose levels in GDM has not been From the 1Departments of Obstetrics and Gynecology, Ohio State University, Columbus, Ohio; the 2George well characterized. Retrospective studies Washington Biostatistics Center, Washington, DC; the 3National Institute of Child Health and Human suggest that intensive treatment of GDM 4 5 Development, Bethesda, Maryland; Brown University, Providence, Rhode Island; and the University of may reduce these morbidities (3). Texas at Galveston, Galveston, Texas. *Other members of the National Institute of Child Health and Human Development MFMU Network are As women with GDM represent a listed in the APPENDIX. metabolically heterogeneous group, this Address correspondence and reprint requests to Mark B. Landon, MD, The Ohio State University, College likely translates into a broad range of peri- of Medicine, Means Hall, 5th Floor, 1654 Upham Dr., Columbus, OH 43210-1228. E-mail: natal risk. This contributes to the contro- [email protected]. Received for publication 28 March 2006 and accepted in revised form 5 June 2006. versy surrounding whether a treatment This article is based on a presentation at a symposium. The symposium and the publication of this article benefit exists for pregnancies complicated were made possible by an unrestricted educational grant from LifeScan, Inc., a Johnson & Johnson company. by this disorder. Despite longstanding Abbreviations: GDM, gestational diabetes mellitus; MFMU, Maternal-Fetal Medicine Unit. recognition of this problem, little A table elsewhere in this issue shows conventional and Syste`me International (SI) units and conversion factors for many substances. progress has been made in developing ev- DOI: 10.2337/dc07-s215 idence-based guidelines for screening and © 2007 by the American Diabetes Association. treatment (4). Nearly 15 years ago, an in- S194 DIABETES CARE, VOLUME 30, SUPPLEMENT 2, JULY 2007 Landon and Associates Figure 1—Reprinted with permission from Landon et al. (5). ternational consensus conference on the and the National Institute of Diabetes and treat gestational diabetes mellitus in order adverse effects of gestational diabetes co- Digestive and Kidney Disease concluded to prevent adverse perinatal effects cannot sponsored by the National Institute of that “the sensitivity, specificity, and cost- be resolved without additional carefully Child Health and Human Development effectiveness of efforts to diagnosis and designed studies” (14). Similar conclu- DIABETES CARE, VOLUME 30, SUPPLEMENT 2, JULY 2007 S195 MFMU Network randomized clinical trial sions have been reached by the Canadian failed to blind practitioners to the diagno- ordinating Center of George Washington Task Force on periodic health examina- sis, which can affect obstetric decision University. Four groups of women are be- tion and by the U.S. Preventive Services making. Thus, a trial blinding the control ing enrolled. Women with mild GDM are Task Force (15). Most women in the U.S. group and practitioners to the oral glu- centrally randomized to one of two are subjected to glucose screening during cose tolerance test results was critical to groups (denoted groups I and IIA, respec- pregnancy followed by formal diagnostic our study design. In selecting criteria for tively): Group 1: Formal nutritional testing in ϳ15–20% of the population. inclusion, it was apparent that practitio- counseling and diet therapy, along with GDM is being diagnosed with increasing ners and institutional review boards insulin if required; Group IIA: No specific frequency based on the less stringent re- would not accept blinding of test results treatment. vised criteria proposed by the Fourth In- in women with fasting hyperglycemia. In addition, women with a positive ternational Workshop-Conference. Most Moreover, many women with fasting hy- 50-g glucose challenge test, but with a of these additional cases represent mild perglycemia might have underlying overt normal subsequent oral glucose tolerance GDM, which undergo a variety of obstet- diabetes with associated increased perina- test, will be enrolled centrally in an obser- rical and medical interventions through- tal risk. However, a prospective clinical vational cohort (denoted group IIB) out the remainder of their pregnancy. trial involving women with milder forms matched by race and BMI (Ͻ27 kg/m2, Such interventions for GDM are currently of hyperglycemia was acceptable to both Ն27 kg/m2) to the women randomized to without much scientific justification and, the Steering Committee of the MFMU “no treatment.” Participating centers will in fact, may present risk to the patient so Network and Advisory Board based on be notified that a patient has been en- diagnosed. Studies have demonstrated a the lack of current evidence supporting rolled in group II and will thus be un- consistently higher rate of cesarean sec- treatment of this group of women. aware of whether the individual is a mild tion for those women designated as hav- GDM subject. ing GDM (16). STUDY DESIGN — We have previ- A group of nondiabetic control sub- The Maternal-Fetal Medicine Unit ously reported the design of this clinical jects with a negative 50-g glucose toler- (MFMU) Network of the National Insti- trial (5). The study aims to address the ance test (value Ͻ120 mg/dl) will also be tute of Child Health and Human Devel- primary research question, “Do women enrolled by the clinical centers. Recruit- opment conducts multicenter clinical with a singleton pregnancy diagnosed ment will be controlled by the Biostatisti- studies that address important issues in with mild gestational diabetes between 24 cal Coordinating Center for nondiabetic maternal-fetal medicine and obstetrics. and 29 weeks of gestation receiving diet patients in each race/BMI category. The Over a decade ago, the MFMU Network
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