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

Primary Purpose

Gestational Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GDM screening with 75 g 2 hour GTT
GDM screening with two step approach
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gestational Diabetes

Eligibility Criteria

16 Years - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregestational Diabetes Mellitus
  • History of bariatric surgery

Sites / Locations

  • Thomas Jefferson University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

One Step

Two Step

Arm Description

The intervention is gestational diabetes screening with 2 hour GTT 75 g load.

There is no intervention is this arm as patients will subjected to routine gestational diabetes screening with one hour glucola, 50 g load.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

neonatal hyperbilirubinemia
incidence of neonatal hyperbilirubinemia
mode of delivery
incidence of cesarean delivery, spontaneous vaginal delivery, operative vaginal delivery, and induction of labor
gestational age at delivery
gestational age at delivery
Anal sphincter injury
Incidence of Anal sphincter injury
Shoulder dystocia
incidence of shoulder dystocia, and birth trauma
Neonatal complications
includes necrotizing enterocolitis, respiratory distress syndrome, intraventricular hemorrhage, hypoglycemia, jaundice, hyperbilirubinemia, perinatal death, admission to neonatal intensive care unit
Hypertensive disorders in pregnancy
includes gestational hypertension, preeclampsia
Fetal growth restriction, large for gestational age and polyhydramnios
Incidence of Fetal growth restriction,large for gestational age and polyhydramnios
Birth weight
Mean of birth weight and incidence of macrosomia
Apgar score
Apgar score

Full Information

First Posted
August 11, 2016
Last Updated
March 2, 2017
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT03073330
Brief Title
One Step Versus Two Step Approach for Gestational Diabetes Mellitus Screening
Acronym
OTSAS
Official Title
One vs Two Step Approach for GDM Screening
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
284 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One Step
Arm Type
Experimental
Arm Description
The intervention is gestational diabetes screening with 2 hour GTT 75 g load.
Arm Title
Two Step
Arm Type
Active Comparator
Arm Description
There is no intervention is this arm as patients will subjected to routine gestational diabetes screening with one hour glucola, 50 g load.
Intervention Type
Diagnostic Test
Intervention Name(s)
GDM screening with 75 g 2 hour GTT
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
GDM screening with two step approach
Intervention Description
1 hour glucola with 50 g glucose load followed by 100 g glucose load if 1 hour glucola positive
Primary Outcome Measure Information:
Title
Incidence of gestational diabetes diagnosed on each screening test of each arm.
Description
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
Secondary Outcome Measure Information:
Title
neonatal hyperbilirubinemia
Description
incidence of neonatal hyperbilirubinemia
Time Frame
first 48 hours of life
Title
mode of delivery
Description
incidence of cesarean delivery, spontaneous vaginal delivery, operative vaginal delivery, and induction of labor
Time Frame
at time of delivery
Title
gestational age at delivery
Description
gestational age at delivery
Time Frame
at time of delivery
Title
Anal sphincter injury
Description
Incidence of Anal sphincter injury
Time Frame
at time of delivery
Title
Shoulder dystocia
Description
incidence of shoulder dystocia, and birth trauma
Time Frame
at time of delivery
Title
Neonatal complications
Description
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
Title
Hypertensive disorders in pregnancy
Description
includes gestational hypertension, preeclampsia
Time Frame
6 months
Title
Fetal growth restriction, large for gestational age and polyhydramnios
Description
Incidence of Fetal growth restriction,large for gestational age and polyhydramnios
Time Frame
6 months
Title
Birth weight
Description
Mean of birth weight and incidence of macrosomia
Time Frame
Time of delivery
Title
Apgar score
Description
Apgar score
Time Frame
at 1, 5 and 10 minutes after birth

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women (limits the participants to female gender)
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adeeb Khalifeh, MD
Email
adeeb.khalifeh@jefferson.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeeb Khalifeh
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adeeb Khalifeh, MD
Email
adeeb.khalifeh@jefferson.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12081977
Citation
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.
Results Reference
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One Step Versus Two Step Approach for Gestational Diabetes Mellitus Screening

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