NCT03073330

One Step Versus Two Step Approach for Gestational Diabetes Mellitus Screening

One vs Two Step Approach for GDM Screening

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 284 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 16 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Our study will assess if there is a difference in incidence of gestational diabetes using different screening approaches, either using a one-step approach with a 2 hour glucose tolerance test or using a two-step approach. Prior studies have proven similar incidences including a randomized controlled trial.

Detailed description

Gestational Diabetes is screened for in pregnancy by drinking a solution containing a certain amount of glucose and testing blood glucose level one hour after drinking it. If this value is above a certain cut-off (\>135mg/dl), the patient is subjected to another test involving drinking a solution containing a higher amount of glucose and checking blood glucose while fasting, 1 hour after drinking the solution and 2 hours after drinking the solution. (Two step approach). Cut off values will be: 3 hour\>180 mg/dl, 2 hour \> 155 mg/dl, 1hour \>140 mg/dl, fasting \>95mg/dl. Two abnormal values will meet the diagnosis of gestational diabetes. In other parts of the United States, and most of the rest of the word, screening for gestational diabetes uses a one-step approach by drinking a solution containing 75g of glucose (As recommended by the American Diabetic Society, the Endocrine Society, WHO and the International Association of Diabetes and Pregnancy Study groups1-3). Blood glucose values are checked at fasting, one hour and two hours after solution drinking. The diagnosis of gestational diabetes is based on one elevated values. (cut off: Fasting ≥92mg/dl, 1hour ≥180 mg/dl, 2 hours ≥153 mg/dl). Our study will assess if there is a difference in incidence of gestational diabetes using these different screening approaches. Prior studies have proven similar incidences including a randomized controlled trial.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	GDM screening with 75 g 2 hour GTT	Patients will be diagnosed with gestational diabetes if they have one abnormal value: Fasting ≥ 92; 2 hour ≥ 180 mg/dl;1 hour ≥ 153 mg/dl.
DIAGNOSTIC_TEST	GDM screening with two step approach	1 hour glucola with 50 g glucose load followed by 100 g glucose load if 1 hour glucola positive

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-03-01
• Completion: 2017-06-01
• First posted: 2017-03-08
• Last updated: 2017-03-08

Locations

1 site across 1 country: United States