Gestational Diabetes Diagnostic Methods (GD2M)

February 2, 2016 updated by: University of Pittsburgh

GD2M Study:Gestational Diabetes Diagnostic Methods

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Womens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 75 Gram OGTT
The 2011 ADA criteria will be used to diagnose gestational diabetes in this study arm.
Behavioral: Dietary modification and medications
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.
Active Comparator: 100 gram OGTT
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.
Behavioral: Dietary modification and medications
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Macrosomia
Time Frame: Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
Defined as birthweight >90th percentile for gestational age or birthweight >4000 grams
Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
Cesarean delivery
Time Frame: Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
Primary or repeat cesarean delivery
Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
Diagnosis of gestational diabetes
Time Frame: Will be followed from study enrollment until delivery (approximately 40 weeks' gestation)
Assess how frequently a diagnosis of gestational diabetes is made
Will be followed from study enrollment until delivery (approximately 40 weeks' gestation)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pre-eclampsia or gestational hypertension
Time Frame: Will be assessed from study enrollment until 30 days after delivery
New onset hypertension +/- proteinuria
Will be assessed from study enrollment until 30 days after delivery
Neonatal hypoglycemia
Time Frame: First 24 hours of life
Defined as blood glucose less than 80 mg/dL from heel stick within 1 hour after delivery
First 24 hours of life
Neonatal hyperbilirubinemia
Time Frame: First 7 days of life
Defined as bilirubin greater than 5 mg/dL over 24 hours from heel stick
First 7 days of life
Infant birth trauma
Time Frame: Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
Defined as shoulder dystocia/brachial plexus injuries
Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
Maternal birth trauma
Time Frame: Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)
3rd or 4th degree perineal laceration or postpartum hemorrhage
Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christina M Scifres, MD, University of Pittsburgh
  • Principal Investigator: Esa Davis, MD MPH, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO11080682

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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