Early Screen and Treatment for Gestational Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Gestational Diabetes Mellitus: Does Early Screening and Treatment for Patients at Increased Risk for Gestational Diabetes Impact Perinatal Outcomes? A Randomized Controlled Trial

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Other: Early glucose screen group
* Other: Standard glucose screen group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Early glucose screen group<br>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<br>* 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<br>|
| Other: Standard glucose screen group<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal weight gain |  | up to delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early glucose screen, perinatal outcome