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Clinical Trials/NCT03073330
NCT03073330UnknownNot Applicable

One vs Two Step Approach for GDM Screening

Thomas Jefferson University2 sites in 1 country284 target enrollmentStarted: June 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

adeeb khalifeh

Physician Fellow

Thomas Jefferson University

Study Sites (2)

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