Early Screen and Treatment for Gestational Diabetes

NCT02377531 | Unknown

• 1 other identifier: Pro00020026
• Study Type: interventional
• Target: 1,020
• Locations: 1 country
• Sites: 2

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.

Conditions

Gestational Diabetes

Keywords

early glucose screen, perinatal outcome

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 28 days after birth

Secondary Outcomes (1)

• Maternal weight gain

  up to delivery

Study Arms (2)

Early glucose screen group

OTHER

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

Standard glucose screen group

OTHER

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

Interventions

Early glucose screen group OTHER

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

Early glucose screen group

Standard glucose screen group OTHER

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

Standard glucose screen group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (2)

USF Health South Tampa Center for Advanced Healthcare

Tampa, Florida, 33606, United States

Location

TGH Health Park Genesis Clinic

Tampa, Florida, 33610, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alejandro Rodriguez, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

• Judette Louis, MD, MPH

  University of South Florida

  STUDY CHAIR

• Linda Odibo

  University of South Florida

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 3, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

US (2)