Clinical trial NCT02309138: Comparison of Two Screening Strategies for Gestational Diabetes (GDM2)
Official title: Comparison of Two Screening Strategies for Gestational Diabetes (GDM2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Pregnancy
Glucose Intolerance
Keywords: gestational diabetes screening
Carpenter Coustan Criteria
IADPSG criteria
Large for gestational age birth weight
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-12-05
Enrollment: 921
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This is a single site blinded RCT of 920 pregnant women with singleton gestation designed to compare the Carpenter-Coustan and IADPSG criteria for diagnosing gestational diabetes. Maternal metabolic profiles and infant growth will be assessed at randomization and at one year postpartum.

Detailed description: Impaired glucose metabolism (gestational diabetes (GDM) and mild hyperglycemia) that occurs during pregnancy is associated with an increased risk for pregnancy complications and is also an early indication of long-term metabolic dysfunction leading to diabetes and cardiovascular disease. In the US, GDM is diagnosed using a two-step screening and diagnostic approach. The International Association of Diabetes and Pregnancy Study Group (IADPSG) proposed a one-step diagnostic approach that broadens the definition of GDM by lowering the cutoff values to include women with milder forms of hyperglycemia, who would have screened normal under the current two-step approach. The goal of these recommendations is better identification of women at risk for pregnancy complications and long-term metabolic dysfunction, but it results in a significant increase in the prevalence of GDM. The NIH GDM Consensus Development Conference committee does not recommend changing from the current two-step screening/diagnostic approach to the IADPSG one-step diagnostic approach without trials demonstrating that increasing the number of women diagnosed as having GDM results in better outcomes. We aim to 1) conduct a "real world" randomized controlled trial (RCT) to determine differences in short-term perinatal health outcomes between the two predominant GDM screening approaches, and 2) prospectively follow the mothers to examine their metabolic risk profiles and the growth of their infants at 1 year postpartum. Based on a pilot study, we propose a single site blinded RCT of 920 pregnant women ages 18-45 years without a diagnosis of diabetes, with a singleton pregnancy (18-24 wks gestation). Participants will have a non-fasting 1 hour 50 gm glucose challenge test (GCT) performed between 24-28 weeks' gestation. Women with 50 gm GCT results \< 200 mg/dL will be randomized to receive either a fasting 2 hour 75 gm oral glucose tolerance test (OGTT) or a 3 hour 100 gm OGTT. GDM will be diagnosed using the IADPSG criteria for women receiving the 75 gm OGTT and Carpenter-Coustan criteria for women receiving the 100 gm. Participants and their physicians will be informed of the diagnosis of GDM, but blinded to the specific test results and diagnostic criteria. Participants with GDM will receive treatment from their primary provider. Questionnaires will be used to assess participants' and physicians' views on GDM testing. Metabolic profiles will be assessed at randomization and at a year postpartum. The primary outcome measure is large-for-gestational age fetal growth. The rationale for this RCT is that this is a unique opportunity to compare the two methods. At the end of the study, we will know whether women diagnosed at lower glucose levels with the IADPSG criteria are more likely to have adverse perinatal outcomes. We hypothesize that using IADPSG diagnostic criteria will result in greater detection of women with impaired glucose metabolism and treating these women will reduce adverse perinatal outcomes and prevent long-term metabolic dysfunction. This study will provide level A data for endorsing universal screening guidelines for GDM by major organizations and implementation into clinical care.

Eligibility criteria: Inclusion Criteria:

* Pregnancy between 18-24 weeks of gestation
* Singleton gestation
* Planning to deliver at Magee-Womens Hospital, Pittsburgh, Pennsylvania

Exclusion Criteria:

* Preexisting type 1 or 2 diabetes
* Diabetes diagnosed at less than 24 weeks gestational age (GA)
* Multiple gestations ( e.g. twins or triplets)
* Hypertension requiring medications
* Corticosteroid (IM, oral or IV) use in the 30 days prior to enrollment
* Major congenital anomaly with anticipated preterm delivery due to maternal or fetal indications \< 28 wks GA
* Inability to complete the glucose testing before 30 completed weeks GA
* Advanced HIV( on medications that cause hyperglycemia), severe liver disease, gastric bypass surgery or other illness/surgeries that preclude them from drinking the glucola solution.

Primary outcomes:
measure: Large for Gestational Age (LGA) Infant
timeFrame: at time of delivery
Secondary outcomes:
measure: Cesarean Delivery
timeFrame: at delivery (approximately 40 weeks' gestation)
measure: Maternal Composite Morbidity
timeFrame: at delivery (approximately 40 weeks' gestation)
measure: Neonatal Composite Morbidity
timeFrame: 7 days after birth
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC- Magee Womens Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Esa M Davis, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abebe KZ, Scifres C, Simhan HN, Day N, Catalano P, Bodnar LM, Costacou T, Matthew D, Illes A, Orris S, Duell J, Ly K, Davis EM. Comparison of Two Screening Strategies for Gestational Diabetes (GDM2) Trial: Design and rationale. Contemp Clin Trials. 2017 Nov;62:43-49. doi: 10.1016/j.cct.2017.08.012. Epub 2017 Aug 18.
citation: Davis EM, Abebe KZ, Simhan HN, Catalano P, Costacou T, Comer D, Orris S, Ly K, Decker A, Mendez D, Day N, Scifres CM. Perinatal Outcomes of Two Screening Strategies for Gestational Diabetes Mellitus: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jul 1;138(1):6-15. doi: 10.1097/AOG.0000000000004431.