One Step Versus Two Step Approach for Gestational Diabetes Mellitus Screening

Gestational Diabetes Clinical Trial

— OTSAS  

Official title:

One vs Two Step Approach for GDM Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03073330
• Other study ID #: 8550
• Status: Recruiting
• Phase: N/A
• First received: August 11, 2016
• Last updated: March 2, 2017
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: March 2017
• Source: Thomas Jefferson University
• Contact: Adeeb Khalifeh, MD
• Email: adeeb.khalifeh[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 284
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

• 16-50 year of age

• Pregnant women (limits the participants to female gender)

Exclusion Criteria:

• Pregestational Diabetes Mellitus

• History of bariatric surgery

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Diagnostic Test:
• GDM 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.
• GDM screening with two step approach
1 hour glucola with 50 g glucose load followed by 100 g glucose load if 1 hour glucola positive

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Southwick AM, Wang LX, Long SR, Lee YC. Activity of Sinorhizobium meliloti NodAB and NodH enzymes on thiochitooligosaccharides. J Bacteriol. 2002 Jul;184(14):4039-43. — View Citation

Outcome

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