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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
284
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.
1 hour glucola with 50 g glucose load followed by 100 g glucose load if 1 hour glucola positive
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
RECRUITINGIncidence of gestational diabetes diagnosed on each screening test of each arm.
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
Time frame: at the time of the screening
neonatal hyperbilirubinemia
incidence of neonatal hyperbilirubinemia
Time frame: first 48 hours of life
mode of delivery
incidence of cesarean delivery, spontaneous vaginal delivery, operative vaginal delivery, and induction of labor
Time frame: at time of delivery
gestational age at delivery
gestational age at delivery
Time frame: at time of delivery
Anal sphincter injury
Incidence of Anal sphincter injury
Time frame: at time of delivery
Shoulder dystocia
incidence of shoulder dystocia, and birth trauma
Time frame: at time of delivery
Neonatal complications
includes necrotizing enterocolitis, respiratory distress syndrome, intraventricular hemorrhage, hypoglycemia, jaundice, hyperbilirubinemia, perinatal death, admission to neonatal intensive care unit
Time frame: between birth and 28 days of age
Hypertensive disorders in pregnancy
includes gestational hypertension, preeclampsia
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Time frame: 6 months
Fetal growth restriction, large for gestational age and polyhydramnios
Incidence of Fetal growth restriction,large for gestational age and polyhydramnios
Time frame: 6 months
Birth weight
Mean of birth weight and incidence of macrosomia
Time frame: Time of delivery
Apgar score
Apgar score
Time frame: at 1, 5 and 10 minutes after birth