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Gestational Diabetes Diagnostic Methods (GD2M)

Primary Purpose

Gestational Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary modification and medications
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gestational Diabetes focused on measuring Gestational Diabetes

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Singleton pregnancy
  • Plan to undergo gestational diabetes screening at 24-28 weeks' gestation.

Exclusion Criteria:

  • Existing Type 1 or Type 2 diabetes
  • Diabetes diagnosed early in pregnancy (less than 24 weeks gestation)
  • Multiple gestation (e.g. twins, triplets)
  • Chronic hypertension (requiring medications)
  • Oral, IM or IV corticosteroid use within the previous 30 days
  • Major congenital anomaly or anticipated preterm delivery before 28 weeks
  • Inability to complete 50 gram GCT before 28 completed weeks' gestation
  • Patients with known HIV, Hepatitis B or C virus.

Sites / Locations

  • Magee-Womens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

75 Gram OGTT

100 gram OGTT

Arm Description

The 2011 ADA criteria will be used to diagnose gestational diabetes in this study arm.

A 2 step approach to the diagnosis of gestational diabetes will be used in this arm. Patients who have a 50 gram, 1 hour glucose challenge test result greater than 135 mg/dL will be diagnosed with gestational diabetes if their 3 hour, 100 gram OGTT results exceed the diagnostic threshold recommended by Carpenter and Coustan.

Outcomes

Primary Outcome Measures

Macrosomia
Defined as birthweight >90th percentile for gestational age or birthweight >4000 grams
Cesarean delivery
Primary or repeat cesarean delivery
Diagnosis of gestational diabetes
Assess how frequently a diagnosis of gestational diabetes is made

Secondary Outcome Measures

Pre-eclampsia or gestational hypertension
New onset hypertension +/- proteinuria
Neonatal hypoglycemia
Defined as blood glucose less than 80 mg/dL from heel stick within 1 hour after delivery
Neonatal hyperbilirubinemia
Defined as bilirubin greater than 5 mg/dL over 24 hours from heel stick
Infant birth trauma
Defined as shoulder dystocia/brachial plexus injuries
Maternal birth trauma
3rd or 4th degree perineal laceration or postpartum hemorrhage

Full Information

First Posted
February 15, 2012
Last Updated
February 2, 2016
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT01540396
Brief Title
Gestational Diabetes Diagnostic Methods
Acronym
GD2M
Official Title
GD2M Study:Gestational Diabetes Diagnostic Methods
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a pilot feasibility study of 40 pregnant women to test the investigators' recruitment, enrollment and randomization procedures in preparation to conduct a larger randomized control trial to compare diagnostic methods for gestational diabetes. The two methods that are being compared are the 2 hour 75 gram OGGT (2011 ADA guidelines) versus a 1 hour 50 gram GCT + 3 hour 100 gram OGTT if the 1 hour result is abnormal (Carpenter and Coustan criteria).
Detailed Description
This is a pilot feasibility study of 40 pregnant women between 24-28 weeks gestation to test the investigators recruitment, enrollment and randomization procedures in preparation to conduct a larger randomized control trial to compare diagnostic methods for gestational diabetes. Forty women 18 years of age or older will be recruited at 20-24 weeks pregnancy from the ob/gyn outpatient practices at Magee-Women's hospital (MWH). Eligible women will return to MWH main lab between 24-28 weeks gestation for the routine 1 hour 50gm glucose challenge test. Women with blood glucose values less than 200 will be randomized to receive either the fasting 2 hour 75 gm oral glucose tolerance test (OGTT)or the 3 hour 100 gm OGGT within two weeks. Gestational diabetes will be determined for the 2 hour 75 gm OGGT arm based on the 2011 ADA guidelines and the 3 hour 100 gm OGGT arm based on the Carpenter and Coustan criteria. Patients and their providers will be informed of the diagnosis of gestational diabetes, but they will be blinded to the criteria used to make the diagnosis as well as the specific results of glucose tolerance testing. Chart reviews will be conducted to assess for perinatal maternal and infant health factors (e.g.pregnancy weight, gestational weight gain, co morbidities) as well as for data on perinatal outcomes related to GDM such as macrosomia, c-sections, and birth trauma. Two brief self-administered questionnaire will assess participants' views on screening for gestational diabetes and assess participants experience with and solicit feedback on the study procedures. At the end of this pilot study, the investigators will have experience with recruitment, retention, and randomization procedures and have made the necessary protocol revisions. If successful, this feasibility study will provide the preliminary data and feasibility justification needed to conduct a larger randomized control trial to compare the effectiveness of two diagnostic methods for gestational diabetes.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
75 Gram OGTT
Arm Type
Active Comparator
Arm Description
The 2011 ADA criteria will be used to diagnose gestational diabetes in this study arm.
Arm Title
100 gram OGTT
Arm Type
Active Comparator
Arm Description
A 2 step approach to the diagnosis of gestational diabetes will be used in this arm. Patients who have a 50 gram, 1 hour glucose challenge test result greater than 135 mg/dL will be diagnosed with gestational diabetes if their 3 hour, 100 gram OGTT results exceed the diagnostic threshold recommended by Carpenter and Coustan.
Intervention Type
Behavioral
Intervention Name(s)
Dietary modification and medications
Intervention Description
Patients diagnosed with gestational diabetes will receive dietary advice and instruction on blood glucose monitoring from their regular prenatal doctors, consistent with standard of care practices. Medications (glyburide, insulin) will be used as needed to assist with blood glucose control.
Primary Outcome Measure Information:
Title
Macrosomia
Description
Defined as birthweight >90th percentile for gestational age or birthweight >4000 grams
Time Frame
Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
Title
Cesarean delivery
Description
Primary or repeat cesarean delivery
Time Frame
Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
Title
Diagnosis of gestational diabetes
Description
Assess how frequently a diagnosis of gestational diabetes is made
Time Frame
Will be followed from study enrollment until delivery (approximately 40 weeks' gestation)
Secondary Outcome Measure Information:
Title
Pre-eclampsia or gestational hypertension
Description
New onset hypertension +/- proteinuria
Time Frame
Will be assessed from study enrollment until 30 days after delivery
Title
Neonatal hypoglycemia
Description
Defined as blood glucose less than 80 mg/dL from heel stick within 1 hour after delivery
Time Frame
First 24 hours of life
Title
Neonatal hyperbilirubinemia
Description
Defined as bilirubin greater than 5 mg/dL over 24 hours from heel stick
Time Frame
First 7 days of life
Title
Infant birth trauma
Description
Defined as shoulder dystocia/brachial plexus injuries
Time Frame
Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
Title
Maternal birth trauma
Description
3rd or 4th degree perineal laceration or postpartum hemorrhage
Time Frame
Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Singleton pregnancy Plan to undergo gestational diabetes screening at 24-28 weeks' gestation. Exclusion Criteria: Existing Type 1 or Type 2 diabetes Diabetes diagnosed early in pregnancy (less than 24 weeks gestation) Multiple gestation (e.g. twins, triplets) Chronic hypertension (requiring medications) Oral, IM or IV corticosteroid use within the previous 30 days Major congenital anomaly or anticipated preterm delivery before 28 weeks Inability to complete 50 gram GCT before 28 completed weeks' gestation Patients with known HIV, Hepatitis B or C virus.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina M Scifres, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Esa Davis, MD MPH
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Gestational Diabetes Diagnostic Methods

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