One vs Two Step Approach for GDM Screening
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Thomas Jefferson University
- Enrollment
- 284
- Locations
- 2
- Primary Endpoint
- Incidence of gestational diabetes diagnosed on each screening test of each arm.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 50 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •16-50 year of age
- •Pregnant women (limits the participants to female gender)
Exclusion Criteria
- •Pregestational Diabetes Mellitus
- •History of bariatric surgery
Outcomes
Primary Outcomes
Incidence of gestational diabetes diagnosed on each screening test of each arm.
Time Frame: at the time of the screening
Gestational diabetes will be made based on one abnormal value. Fasting ≥126 mg/dl; 1 hour≥ 180 mg/dl and 2 hour ≥ 153 mg/dl
Secondary Outcomes
- neonatal hyperbilirubinemia(first 48 hours of life)
- Birth weight(Time of delivery)
- Hypertensive disorders in pregnancy(6 months)
- mode of delivery(at time of delivery)
- Neonatal complications(between birth and 28 days of age)
- Fetal growth restriction, large for gestational age and polyhydramnios(6 months)
- Anal sphincter injury(at time of delivery)
- gestational age at delivery(at time of delivery)
- Shoulder dystocia(at time of delivery)
- Apgar score(at 1, 5 and 10 minutes after birth)
Investigators
adeeb khalifeh
Physician Fellow
Thomas Jefferson University
