Recruiting

One Step vs. Two Step

Sponsor:

Thomas Jefferson University

Code:

NCT03073330

Conditions

Gestational Diabetes

Eligibility Criteria

Sex: Female

Age: 16 - 50

Healthy Volunteers: Accepted

Interventions

GDM screening with 75 g 2 hour GTT

GDM screening with two step approach

Study Details

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.

Conditions

Gestational Diabetes

Study ID

NCT03073330

Start date

Jun, 2016

Status verified date

Mar, 2017

Completion date

Jun, 2017

Anticipated

Primary completion date

Mar, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregestational Diabetes Mellitus
  • History of bariatric surgery

Study Design

Enrollment

284 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: One Step

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

active comparator: 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.

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.

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

Primary outcome measure

  • Incidence of gestational diabetes diagnosed on each screening test of each arm. [ Time Frame: at the time of the screening ]

Central Contacts and Locations

Central contacts

Adeeb Khalifeh, MD

adeeb.khalifeh@jefferson.edu

Locations

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Adeeb Khalifeh, MD

adeeb.khalifeh@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Mar 8, 2017

Last verified

Mar, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2017-03-08.