Early Screen and Treatment for Gestational Diabetes

University of South Florida1,020 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

1,020

Conditions

Gestational Diabetes

Interventions

Early glucose screen groupOTHER

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 groupOTHER

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

USF Health South Tampa Center for Advanced Healthcare

Tampa, Florida, United States

TGH Health Park Genesis Clinic

Tampa, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: up to 28 days after birth

Secondary Outcomes

Maternal weight gain

Time frame: up to delivery

Data from ClinicalTrials.gov

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