One Step Versus Two Step Approach for Gestational Diabetes Mellitus Screening

Study Overview
=================
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.

Official Title
-----------------
One vs Two Step Approach for GDM Screening

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Diagnostic Test: GDM screening with 75 g 2 hour GTT
* Diagnostic Test: GDM screening with two step approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 16-50 year of age Pregnant women (limits the participants to female gender) Exclusion Criteria: Pregestational Diabetes Mellitus History of bariatric surgery

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One Step<br>The intervention is gestational diabetes screening with 2 hour GTT 75 g load. | Diagnostic Test: GDM screening with 75 g 2 hour GTT<br>* 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.<br>|
| Active Comparator: Two Step<br>There is no intervention is this arm as patients will subjected to routine gestational diabetes screening with one hour glucola, 50 g load. | Diagnostic Test: GDM screening with two step approach<br>* 1 hour glucola with 50 g glucose load followed by 100 g glucose load if 1 hour glucola positive<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence 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 | at the time of the screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neonatal hyperbilirubinemia | incidence of neonatal hyperbilirubinemia | first 48 hours of life | 
| mode of delivery | incidence of cesarean delivery, spontaneous vaginal delivery, operative vaginal delivery, and induction of labor | at time of delivery | 
| gestational age at delivery | gestational age at delivery | at time of delivery | 
| Anal sphincter injury | Incidence of Anal sphincter injury | at time of delivery | 
| Shoulder dystocia | incidence of shoulder dystocia, and birth trauma | 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 | between birth and 28 days of age | 
| Hypertensive disorders in pregnancy | includes gestational hypertension, preeclampsia | 6 months | 
| Fetal growth restriction, large for gestational age and polyhydramnios | Incidence of Fetal growth restriction,large for gestational age and polyhydramnios | 6 months | 
| Birth weight | Mean of birth weight and incidence of macrosomia | Time of delivery | 
| Apgar score | Apgar score | at 1, 5 and 10 minutes after birth |