Gestational Diabetes
Conditions
Brief summary
Our study will assess if there is a difference in incidence of gestational diabetes using different screening approaches, either using a one-step approach with a 2 hour glucose tolerance test or using a two-step approach. Prior studies have proven similar incidences including a randomized controlled trial.
Detailed description
Gestational Diabetes is screened for in pregnancy by drinking a solution containing a certain amount of glucose and testing blood glucose level one hour after drinking it. If this value is above a certain cut-off (\>135mg/dl), the patient is subjected to another test involving drinking a solution containing a higher amount of glucose and checking blood glucose while fasting, 1 hour after drinking the solution and 2 hours after drinking the solution. (Two step approach). Cut off values will be: 3 hour\>180 mg/dl, 2 hour \> 155 mg/dl, 1hour \>140 mg/dl, fasting \>95mg/dl. Two abnormal values will meet the diagnosis of gestational diabetes. In other parts of the United States, and most of the rest of the word, screening for gestational diabetes uses a one-step approach by drinking a solution containing 75g of glucose (As recommended by the American Diabetic Society, the Endocrine Society, WHO and the International Association of Diabetes and Pregnancy Study groups1-3). Blood glucose values are checked at fasting, one hour and two hours after solution drinking. The diagnosis of gestational diabetes is based on one elevated values. (cut off: Fasting ≥92mg/dl, 1hour ≥180 mg/dl, 2 hours ≥153 mg/dl). Our study will assess if there is a difference in incidence of gestational diabetes using these different screening approaches. Prior studies have proven similar incidences including a randomized controlled trial.
Interventions
DIAGNOSTIC_TESTGDM screening with 75 g 2 hour GTT
Patients will be diagnosed with gestational diabetes if they have one abnormal value: Fasting ≥ 92; 2 hour ≥ 180 mg/dl;1 hour ≥ 153 mg/dl.
DIAGNOSTIC_TESTGDM screening with two step approach
1 hour glucola with 50 g glucose load followed by 100 g glucose load if 1 hour glucola positive
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 16-50 year of age * Pregnant women (limits the participants to female gender)
Exclusion criteria
* Pregestational Diabetes Mellitus * History of bariatric surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of gestational diabetes diagnosed on each screening test of each arm. | at the time of the screening | Gestational diabetes will be made based on one abnormal value. Fasting ≥126 mg/dl; 1 hour≥ 180 mg/dl and 2 hour ≥ 153 mg/dl |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mode of delivery | at time of delivery | incidence of cesarean delivery, spontaneous vaginal delivery, operative vaginal delivery, and induction of labor |
| gestational age at delivery | at time of delivery | gestational age at delivery |
| Anal sphincter injury | at time of delivery | Incidence of Anal sphincter injury |
| Shoulder dystocia | at time of delivery | incidence of shoulder dystocia, and birth trauma |
| neonatal hyperbilirubinemia | first 48 hours of life | incidence of neonatal hyperbilirubinemia |
| Hypertensive disorders in pregnancy | 6 months | includes gestational hypertension, preeclampsia |
| Fetal growth restriction, large for gestational age and polyhydramnios | 6 months | Incidence of Fetal growth restriction,large for gestational age and polyhydramnios |
| Birth weight | Time of delivery | Mean of birth weight and incidence of macrosomia |
| Apgar score | at 1, 5 and 10 minutes after birth | Apgar score |
| Neonatal complications | between birth and 28 days of age | includes necrotizing enterocolitis, respiratory distress syndrome, intraventricular hemorrhage, hypoglycemia, jaundice, hyperbilirubinemia, perinatal death, admission to neonatal intensive care unit |
Countries
United States
Contacts
Primary ContactAdeeb Khalifeh, MD
Outcome results
None listed