ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Screen and Treatment for Gestational Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02377531
Recruitment Status : Recruiting
First Posted : March 3, 2015
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
In the current study we aim to determine if early glucose screening and treatment among women at high risk for GDM improves perinatal outcome and decreases gestational weight gain. Half of the participant will be assigned to an early glucose screen group (12-18 weeks) and treatment if necessary and the other half to a standard 24-28 weeks glucose screen.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Other: Early glucose screen group Other: Standard glucose screen group Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Gestational Diabetes Mellitus: Does Early Screening and Treatment for Patients at Increased Risk for Gestational Diabetes Impact Perinatal Outcomes? A Randomized Controlled Trial
Study Start Date : March 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Early glucose screen group
Participants with high risk factors for gestational diabetes, will be randomly assigned to an early glucose screen group: it consists of an oral load of 50 grams of glucose followed by a measurement of serum glucose 1 hour later, and if abnormal (higher than 130mg/dl), will undergo a 100 gram oral load of glucose followed by serum glucose levels drawn 1,2 and 3 hours after the load. If abnormal according to Carpenter-Cousant criteria, the participant will undergo standard of care for Gestational Diabetes.
Other: Early glucose screen group
Main intervention is randomization: half of the participants will be randomized to undergo a 50 gram oral glucose load with a 1 hour serum glucose measurement as a screen for Gestational Diabetes mellitus at 12 to 18 weeks of pregnancy instead of standard 24 to 28 weeks of pregnancy

Standard glucose screen group
The participants in this group will be randomized to undergo the testing process previously described at 24 to 28 weeks.
Other: Standard glucose screen group
Main intervention is randomization: half of the participants will be randomized to undergo a 50 gram oral glucose load with a 1 hour serum glucose measurement as a screen for Gestational Diabetes mellitus at 24 to 28 weeks of pregnancy




Primary Outcome Measures :
  1. Composite Perinatal morbidity [ Time Frame: up to 28 days after birth ]
    The primary study outcome is a composite of perinatal morbidities including perinatal mortality (stillbirth or neonatal death), neonatal hypoglycemia, hyperbilirubinemia, and birth trauma. Transcutaneous bilirubin is routinely measured at Tampa General Hospital (TGH) on all babies at least once. A value greater than the 95th percentile for or need for phototherapy at any given point after birth will be considered an elevated level. Birth trauma is defined as brachial plexus palsy or clavicular, humeral, or skull fracture.


Secondary Outcome Measures :
  1. Maternal weight gain [ Time Frame: up to delivery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Pregnant subjects 18-45 y/o and Any of the following:

Obesity defined as having a BMI>30 kg/m2 History of pregnancy complicated with GDM History of pregnancy complicated with macrosomia First degree relative with diabetes Multiple gestation

Exclusion Criteria:

  • Incomplete Data: if any data is missing (i.e Delivery data) , analysis cannot be completed.

Pregnancy complicated with fetal malformations or aneuploidy: It affects prenatal care, mode of delivery as well as perinatal outcome.

Pregestational or Overt Diabetes: Patients with Diabetes cannot be diagnosed with GDM.

Chronic medical conditions such as hypertension, renal disease, autoimmune conditions: Those conditions may affect prenatal care, perinatal morbidity.

Early diabetes screen performed prior to enrollment in study: Participant cannot be randomized, and probably have been treated.

Medical contraindication to glucose tolerance test (bariatric surgery): patients with h/o gastric bypass frequently cannot tolerate oral glucose load, therefore cannot be screened for GDM in the traditional way.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377531


Contacts
Contact: Alejandro R Rodriguez, MD 813-259-0828 arodri24@health.usf.edu

Locations
United States, Florida
USF Health South Tampa Center for Advanced Healthcare Recruiting
Tampa, Florida, United States, 33606
TGH Health Park Genesis Clinic Recruiting
Tampa, Florida, United States, 33610
Contact: Alejandro Rodriguez, MD       arodri24@health.usf.edu   
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Alejandro Rodriguez, MD University of South Florida
Study Chair: Judette Louis, MD, MPH University of South Florida
Study Director: Linda Odibo University of South Florida

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02377531     History of Changes
Other Study ID Numbers: Pro00020026
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017

Keywords provided by University of South Florida:
early glucose screen, perinatal outcome

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications