One Step Versus Two Step Approach for Gestational Diabetes Mellitus Screening (OTSAS)

Thomas Jefferson University

Status: Unknown

Conditions: Gestational Diabetes

Treatments: Diagnostic Test: GDM screening with 75 g 2 hour GTT; Diagnostic Test: GDM screening with two step approach

Study type: Interventional

Funder types: Other

Identifiers

NCT03073330

8550

Details and patient eligibility

About

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.

Full 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.

Enrollment: 284 estimated patients

Sex: Female

Ages: 16 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 16-50 year of age
• Pregnant women (limits the participants to female gender)

Exclusion criteria

• Pregestational Diabetes Mellitus
• History of bariatric surgery

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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284 participants in 2 patient groups

One Step

Experimental group

Description:

The intervention is gestational diabetes screening with 2 hour GTT 75 g load.

Treatment:

Diagnostic Test: GDM screening with 75 g 2 hour GTT

Two Step

Active Comparator group

Description:

There is no intervention is this arm as patients will subjected to routine gestational diabetes screening with one hour glucola, 50 g load.

Treatment:

Diagnostic Test: GDM screening with two step approach