One Step Versus Two Step Approach for Gestational Diabetes Mellitus Screening (OTSAS)

One vs Two Step Approach for GDM Screening

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.

Study Overview

• Status: Unknown
• Conditions: Gestational Diabetes
• Intervention / Treatment: Diagnostic test: GDM screening with 75 g 2 hour GTT; Diagnostic test: GDM screening with two step approach

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 Type: Interventional
• Enrollment (Anticipated): 284
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adeeb Khalifeh, MD; Email: adeeb.khalifeh@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital
      • Contact: Adeeb Khalifeh, MD; Email: adeeb.khalifeh@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One Step; The intervention is gestational diabetes screening with 2 hour GTT 75 g load.	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.
Active Comparator: Two Step; 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; 1 hour glucola with 50 g glucose load followed by 100 g glucose load if 1 hour glucola positive

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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Adeeb Khalifeh, Thomas Jefferson University

Publications and helpful links

General Publications

• 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. doi: 10.1128/JB.184.14.4039-4043.2002.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational
• Other Study ID Numbers: 8550

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO