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Early Screen and Treatment for Gestational Diabetes

Primary Purpose

Gestational Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early glucose screen group
Standard glucose screen group
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gestational Diabetes focused on measuring early glucose screen, perinatal outcome

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • USF Health South Tampa Center for Advanced Healthcare
  • TGH Health Park Genesis Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Early glucose screen group

Standard glucose screen group

Arm Description

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.

The participants in this group will be randomized to undergo the testing process previously described at 24 to 28 weeks.

Outcomes

Primary Outcome Measures

Composite Perinatal morbidity
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

Maternal weight gain

Full Information

First Posted
February 25, 2015
Last Updated
May 27, 2021
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02377531
Brief Title
Early Screen and Treatment for Gestational Diabetes
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 Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
early glucose screen, perinatal outcome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1020 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early glucose screen group
Arm Type
Other
Arm Description
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.
Arm Title
Standard glucose screen group
Arm Type
Other
Arm Description
The participants in this group will be randomized to undergo the testing process previously described at 24 to 28 weeks.
Intervention Type
Other
Intervention Name(s)
Early glucose screen group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard glucose screen group
Intervention Description
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 Measure Information:
Title
Composite Perinatal morbidity
Description
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.
Time Frame
up to 28 days after birth
Secondary Outcome Measure Information:
Title
Maternal weight gain
Time Frame
up to delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Rodriguez, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Judette Louis, MD, MPH
Organizational Affiliation
University of South Florida
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Linda Odibo
Organizational Affiliation
University of South Florida
Official's Role
Study Director
Facility Information:
Facility Name
USF Health South Tampa Center for Advanced Healthcare
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
TGH Health Park Genesis Clinic
City
Tampa
State/Province
Florida
ZIP/Postal Code
33610
Country
United States

12. IPD Sharing Statement

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Early Screen and Treatment for Gestational Diabetes

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