One Step Versus Two Step Approach for Gestational Diabetes Mellitus Screening

NCT ID: NCT03073330

Last Updated: 2017-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 284 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-06-30

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.

Conditions

Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

One Step

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

Group Type: EXPERIMENTAL

GDM screening with 75 g 2 hour GTT

Intervention Type: DIAGNOSTIC_TEST

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.

Two Step

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

Group Type: ACTIVE_COMPARATOR

GDM screening with two step approach

Intervention Type: DIAGNOSTIC_TEST

1 hour glucola with 50 g glucose load followed by 100 g glucose load if 1 hour glucola positive

Interventions

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.

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pregestational Diabetes Mellitus
• History of bariatric surgery

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

adeeb khalifeh

Physician Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adeeb Khalifeh

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Adeeb Khalifeh, MD

Role: CONTACT

adeeb.khalifeh@jefferson.edu

Facility Contacts

Adeeb Khalifeh, MD

Role: primary

adeeb.khalifeh@jefferson.edu

References

Southwick AM, Wang LX, Long SR, Lee YC. Activity of Sinorhizobium meliloti NodAB and NodH enzymes on thiochitooligosaccharides. J Bacteriol. 2002 Jul;184(14):4039-43. doi: 10.1128/JB.184.14.4039-4043.2002.

Reference Type: RESULT

PMID: 12081977 (View on PubMed)

Other Identifiers

8550

Identifier Type: -

Identifier Source: org_study_id