One Step Versus Two Step Approach for Gestational Diabetes Mellitus Screening

Not Applicable

• Conditions: Gestational Diabetes
• Interventions: Diagnostic Test: GDM screening with 75 g 2 hour GTT; Diagnostic Test: GDM screening with two step approach

• Registration Number: NCT03073330
• Lead Sponsor: Thomas Jefferson University

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-08-11
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study First Submitted QC: 2017-03-02
• Last Update Submitted: 2017-03-02
• Study First Posted: 2017-03-08
• Last Update Posted: 2017-03-08
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 284

Inclusion Criteria

• 16-50 year of age
• Pregnant women (limits the participants to female gender)

Exclusion Criteria

• Pregestational Diabetes Mellitus
• History of bariatric surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One Step	GDM screening with 75 g 2 hour GTT	The intervention is gestational diabetes screening with 2 hour GTT 75 g load.
Two Step	GDM screening with two step approach	There is no intervention is this arm as patients will subjected to routine gestational diabetes screening with one hour glucola, 50 g load.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States