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Comparison of Two Screening Strategies for Gestational Diabetes (GDM2) Trial: Design and rationale.

ABSTRACT: Gestational diabetes mellitus (GDM) affects approximately 5 to 7% of pregnancies and is associated with increased risk for fetal overgrowth, cesarean delivery, birth trauma, and pre-eclampsia. GDM is commonly diagnosed in the US using a two-step screening and confirmatory approach, whereas a one-step approach is commonly used outside the US. Recent guidelines have suggested that the one-step approach should be used to diagnose GDM, although concern that this may increase the prevalence of GDM to approximately 18%-as well as the lack of clinical trials-based evidence regarding the difference in perinatal outcomes-has led to skepticism about adopting the one-step approach. The Comparison of Two Screening Strategies for Gestational Diabetes (GDM2) Trial is a single-center, parallel-arm, comparative effectiveness trial of one-step versus two-step GDM screening strategies on the rate of adverse perinatal outcomes including: large-for-gestational age (LGA) deliveries (primary outcome), small-for-gestational age (SGA), macrosomia, cesarean delivery, fetal growth and body composition, and maternal and neonatal composite outcomes. This paper describes the design and analysis plan of the GDM2 Trial as well as overall challenges in assessing the impact of screening and diagnosis strategy on adverse pregnancy outcomes. We will also assess whether the additional women diagnosed with the one-step approach benefit from treatment as assessed by metabolic profiles at one year postpartum. Ultimately, this study will provide the necessary evidence for establishing universal guidelines for GDM diagnosis and implementation into clinical care.

SUBMITTER: Abebe KZ

PROVIDER: S-EPMC5641255 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Comparison of Two Screening Strategies for Gestational Diabetes (GDM<sup>2</sup>) Trial: Design and rationale.

Abebe Kaleab Z KZ Scifres Christina C Simhan Hyagriv N HN Day Nancy N Catalano Patrick P Bodnar Lisa M LM Costacou Tina T Matthew Deanna D Illes Alexandra A Orris Steven S Duell Jessica J Ly Kathleen K Davis Esa M EM

Contemporary clinical trials 20170818

Gestational diabetes mellitus (GDM) affects approximately 5 to 7% of pregnancies and is associated with increased risk for fetal overgrowth, cesarean delivery, birth trauma, and pre-eclampsia. GDM is commonly diagnosed in the US using a two-step screening and confirmatory approach, whereas a one-step approach is commonly used outside the US. Recent guidelines have suggested that the one-step approach should be used to diagnose GDM, although concern that this may increase the prevalence of GDM to ...[more]

PMID: 28823926

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Project description:ObjectiveTo evaluate differences in short-term perinatal outcomes between the two prominent screening strategies for gestational diabetes mellitus, the International Association of Diabetes and Pregnancy Study Groups (IADPSG) and Carpenter-Coustan.MethodsIn this single-site, blinded, randomized, comparative effectiveness trial, participants received a nonfasting 50-g oral glucose tolerance test and, if less than 200 mg/dL (less than 11.1 mmol/L), were randomized to further screening with either IADPSG or Carpenter-Coustan criteria. Gestational diabetes treatment occurred per routine clinical care. The primary outcome was incidence of large-for-gestational-age (LGA) neonates. Prespecified secondary outcomes included small-for-gestational-age (SGA) neonates, cesarean birth, and neonatal and maternal composites of adverse perinatal outcomes. Assuming a 15% incidence of LGA neonates in the Carpenter-Coustan group, 782 participants provided more than 80% power to detect a 7% absolute risk reduction with the use of IADPSG; planned recruitment was 920 for anticipated attrition.ResultsFrom June 2015 to February 2019, 1,016 participants were enrolled and 921 were randomized to IADPSG (n=461) or Carpenter-Coustan (n=460) groups. Gestational diabetes incidence (14.4% vs 4.5%, P<.001) and diabetes medication use (9.3% vs 2.4%; P<.001) were more common in the IADPSG group; there were no differences in LGA neonates, either overall (risk reduction 0.90, 97.5% CI 0.53-1.52) or among women without gestational diabetes (risk reduction 0.85, 97.5% CI 0.49-1.48). Those screened with IADPSG had higher rates of neonatal morbidity but fewer study-related adverse events. Rates of SGA neonates, cesarean birth, and maternal morbidity composite did not differ significantly between study groups.ConclusionsThe IADPSG screening criteria resulted in more women diagnosed and treated for gestational diabetes than Carpenter-Coustan without reducing the incidence of LGA birth weight or maternal or neonatal morbidity.Clinical trial registrationClinicalTrials.gov, NCT02309138.

Project description:BackgroundWomen with gestational diabetes (GDM) are at high risk of developing diabetes later in life. After a GDM diagnosis, women receive prenatal care to control their blood glucose levels via diet, physical activity and medications. Continuing such lifestyle skills into early motherhood may reduce the risk of diabetes in this high risk population. In the Gestational Diabetes' Effects on Moms (GEM) study, we are evaluating the comparative effectiveness of diabetes prevention strategies for weight management designed for pregnant/postpartum women with GDM and delivered at the health system level.Methods/designThe GEM study is a pragmatic cluster randomized clinical trial of 44 medical facilities at Kaiser Permanente Northern California randomly assigned to either the intervention or usual care conditions, that includes 2,320 women with a GDM diagnosis between March 27, 2011 and March 30, 2012. A Diabetes Prevention Program-derived print/telephone lifestyle intervention of 13 telephonic sessions tailored to pregnant/postpartum women was developed. The effectiveness of this intervention added to usual care is to be compared to usual care practices alone, which includes two pages of printed lifestyle recommendations sent to postpartum women via mail. Primary outcomes include the proportion of women who reach a postpartum weight goal and total weight change. Secondary outcomes include postpartum glycemia, blood pressure, depression, percent of calories from fat, total caloric intake and physical activity levels. Data were collected through electronic medical records and surveys at baseline (soon after GDM diagnosis), 6 weeks (range 2 to 11 weeks), 6 months (range 12 to 34 weeks) and 12 months postpartum (range 35 to 64 weeks).DiscussionThere is a need for evidence regarding the effectiveness of lifestyle modification for the prevention of diabetes in women with GDM, as well as confirmation that a diabetes prevention program delivered at the health system level is able to successfully reach this population. Given the use of a telephonic case management model, our Diabetes Prevention Program-derived print/telephone intervention has the potential to be adopted in other settings and to inform policies to promote the prevention of diabetes among women with GDM.

Project description:Background:There is lack of ideal and comprehensive economic evaluations of various GDM strategies. The aim of this study is to the compare efficacy and cost-effectiveness of five different methods of screening for gestational diabetes mellitus (GDM). Methods:This study is a randomized community non-inferiority trial among 30,000 pregnant women in five different geographic regions of Iran, who were randomly assigned to one of the five GDM screening methods. All first trimester pregnant women, seeking prenatal care in governmental health care systems, who met our eligibility criteria were enrolled. The criteria suggested by the International-Association-of-Diabetes-in-Pregnancy-Study-Group, the most intensive approach, were used as reference. We used the non-inferiority approach to compare less intensive strategies to the reference one. Along with routine prenatal standard care, all participants were scheduled to have two phases of GDM screening in first and second-trimester of pregnancy, based on five different pre-specified protocols. The screening protocol included fasting plasma glucose in the first trimester and either a one step or a two-step screening method in the second trimester of pregnancy. Pregnant women were classified in three groups based on the results: diagnosed with preexisting pre-gestational overt diabetes; gestational diabetes and non-GDM women. Each group received packages for standard-care and all participants were followed till delivery; pregnancy outcomes, quality of life and cost of health care were recorded in detail using specific standardized questionnaires. Primary outcomes were defined as % birth-weight?>?90th percentile and primary cesarean section. In addition, we assessed the direct health care direct and indirect costs. Results:This study will enable us to compare the cost effectiveness of different GDM screening protocols and intervention intensity (low versus high). Conclusion:Results which if needed, will also enable policy makers to optimize the national GMD strategy as a resource for enhancing GDM guidelines.Trial registration Name of the registry: Iranian Registry of Clinical Trials. Trial registration number: IRCT138707081281N1. Date of registration: 2017-02-15. URL of trial registry record: https://www.irct.ir/trial/518.

Project description:BackgroundAlthough in 2013 the American College of Obstetricians and Gynecologists recommended early screening for gestational diabetes in obese women, no studies demonstrate an improvement in perinatal outcomes with this strategy.ObjectiveWe sought to determine whether early screening for gestational diabetes improves perinatal outcomes in obese women.Materials and methodsRandomized controlled trial comparing early gestational diabetes screening (14-20 weeks) to routine screening (24-28 weeks) in obese women (body mass index ≥30 kg/m2) at 2 tertiary care centers in the United States. Screening was performed using a 50-g, 1-hour glucose challenge test followed by a 100-g, 3-hour glucose tolerance test if the initial screen was ≥135 mg/dL. Gestational diabetes was diagnosed using Carpenter-Coustan criteria. Women not diagnosed at 14 to 20 weeks were rescreened at 24 to 28 weeks. Exclusion criteria were pre-existing diabetes, major medical illness, bariatric surgery, and prior cesarean delivery. The primary outcome was a composite of macrosomia (>4000 g), primary cesarean delivery, hypertensive disease of pregnancy, shoulder dystocia, neonatal hyperbilirubinemia, and neonatal hypoglycemia (assessed within 48 hours of birth).ResultsA total of 962 women were randomized, and outcomes were available for 922. Of these 922 women, 459 (49.8%) were assigned to early screen and 463 (50.2%) to routine screen. Baseline characteristics were balanced between groups. In the early screening group, 69 (15.0%; 95% confidence interval, 11.9-18.6%) were diagnosed with gestational diabetes: 29 (6.3%; 95% confidence interval, 4.3-8.9%) at <20 weeks and 40 (8.7%; 95% confidence interval, 6.3-11.7%) at >24 weeks. Of those randomized to routine screening, 56 (12.1%; 95% confidence interval, 9.3-15.4%) had gestational diabetes. Early screening did not reduce the incidence of the primary outcome (56.9% in the early screen versus 50.8% in the routine screen, P = .07; relative risk, 1.12; 95% confidence interval, 0.99-1.26).ConclusionEarly screening for gestational diabetes in obese women did not reduce the composite perinatal outcome.

Project description:BACKGROUND:Early diagnosis of gestational diabetes mellitus (GDM) is crucial to prevent short term delivery risks and long term effects such as cardiovascular and metabolic diseases in the mother and infant. Diagnosing GDM in Sub-Saharan Africa (SSA) however, remains sub-optimal due to associated logistical and cost barriers for resource-constrained populations. A cost-effective strategy to screen for GDM in such settings are therefore urgently required. We conducted this study to determine the prevalence of gestational diabetes mellitus (GDM) and assess utility of various GDM point of care (POC) screening strategies in a resource-constrained setting. METHODS:Eligible women aged ?18 years, and between 24 and 32 weeks of a singleton pregnancy, prospectively underwent testing over two days. On day 1, a POC 1-h 50 g glucose challenge test (GCT) and a POC glycated hemoglobin (HbA1c) was assessed. On day 2, fasting blood glucose, 1-h and 2-h 75 g oral glucose tolerance test (OGTT) were determined using both venous and POC tests, along with a venous HbA1c. The International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria was used to diagnose GDM. GDM prevalence was reported with 95% confidence interval (CI). Specificity, sensitivity, positive predictive value, and negative predictive value of the various POC testing strategies were determined using IADPSG testing as the standard reference. RESULTS:Six hundred-sixteen eligible women completed testing procedures. GDM was diagnosed in 18 women, a prevalence of 2.9% (95% CI, 1.57% - 4.23%). Compared to IADPSG testing, POC IADPSG had a sensitivity and specificity of 55.6% and 90.6% respectively while that of POC 1-h 50 g GCT (using a diagnostic cut-off of ?7.2 mmol/L [129.6 mg/dL]) was 55.6% and 63.9%. All other POC tests assessed showed poor sensitivity. CONCLUSIONS:POC screening strategies though feasible, showed poor sensitivity for GDM detection in our resource-constrained population of low GDM prevalence. Studies to identify sensitive and specific POC GDM screening strategies using adverse pregnancy outcomes as end points are required. TRIALS REGISTRATION:Clinical trials.gov : NCT02978807 , Registered 29 November 2016.

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Comparison of Two Screening Strategies for Gestational Diabetes (GDM2) Trial: Design and rationale.

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Comparison of Two Screening Strategies for Gestational Diabetes (GDM<sup>2</sup>) Trial: Design and rationale.

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