Gestational Diabetes Mellitus: Does Early Screening and Treatment for Patients at Increased Risk for Gestational Diabetes Impact Perinatal Outcomes? A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gestational Diabetes
- Sponsor
- University of South Florida
- Enrollment
- 1020
- Locations
- 2
- Primary Endpoint
- Composite Perinatal morbidity
- Last Updated
- 4 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
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 Outcomes
- Maternal weight gain(up to delivery)