An RCT to Evaluate Incidence, Cost and Clinical Outcomes Using 75 vs 100g. Screening Methods for Gestational Diabetes
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Observational

Summary: 
      Diabetes in pregnancy or gestational diabetes (GDM) is a condition that, if left untreated,
      may lead to complications for the mother and her baby. It is still not known which is the
      best method to diagnosis GDM. The goal of this study is to compare three well-accepted
      methods for diagnosis of GDM (using either 75 g or 100 g in the glucose tolerance test) and
      determine which method is the easiest and least expensive to use in relation to the reference
      method used over the last 20 years. The goal is to see if they can equally predict the
      healthy outcome of the pregnant mother and her newborn.
    

Detailed description: 
      Title: What is the optimal method for screening and diagnosis of gestational diabetes? A
      randomised clinical trial to evaluate incidence of GDM, cost-effectiveness and clinical
      outcomes using three methods.

      Objectives: 1) To evaluate the incidence and cost-effectiveness of screening and diagnosis of
      GDM by comparing three different methods. 2) To evaluate the following by each method:
      population characteristics; gestational age at screening, diagnosis and initiation of
      treatment; and maternal and neonatal outcomes.

      Rationale: There is no consensus on the best method to identify cases of GDM, numerous
      screening and diagnostic procedures are employed worldwide. Recently the Canadian Guidelines
      recommended a new set of values based on normative data, yet these data have not been
      validated against a large population and compared with diagnostic rates and outcomes head to
      head against the long accepted values of O'Sullivan and Mahan. In addition, the question of
      cost in a Canadian healthcare setting has never been addressed yet it is a significant
      societal concern. The results of this study would help clarify these issues using
      evidence-based methodology.

      Outline: Pregnant women referred as outpatients for glucose testing for GDM will be given a
      study information sheet by obstetrics staff. At the time of booking the test they will be
      reminded of the study and to arrive fasting. On the day of glucose testing, the research
      assistant will invite patients to participate, obtain consent and perform randomisation into
      one three groups:

      (1) 50g screen ± 100g 3h GTT; (2) 50g screen ± 75g 2h GTT; or (3) 75g 2h GTT. During the
      glucose test, study participants will also be asked information on health and costs incurred
      for the process of glucose testing. If the screen or GTT needs to be repeated at some time
      during the pregnancy, patients will remain in the same study arm as originally assigned.
      Interpretation of results by patient's caregivers and referral to the diabetes clinic as
      needed will continue as usual. Data will be analysed using appropriate bivariate and
      multivariate methods for GDM incidence, direct and indirect costs of glucose testing, and
      maternal and infant outcomes.

      Significance to DM: This study will evaluate the diagnostic efficacy, cost-effectiveness and
      clinical outcomes of three methods. A one-step procedure may be better tolerated compared to
      a two-step approach with respect to number of visits, amount of drink and length of testing.
      Furthermore, diagnosis by a single test may avoid unnecessary delay in initiation of therapy
      and still identify those patients at risk for type 2 DM.
    

Time perspective: Other
Keywords: Gestational Diabetes; Screening; Cost-effectiveness; obstetrical outcomes