Trial record 2 of 283 for:    gestational diabetes

Gestational Diabetes Diagnostic Methods (GD2M)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Christina Scifres, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01540396
First received: February 15, 2012
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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).


Condition Intervention
Gestational Diabetes
Behavioral: Dietary modification and medications

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Diagnostic
Official Title: GD2M Study:Gestational Diabetes Diagnostic Methods

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Macrosomia [ Time Frame: Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation) ] [ Designated as safety issue: No ]
    Defined as birthweight >90th percentile for gestational age or birthweight >4000 grams

  • Cesarean delivery [ Time Frame: Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation) ] [ Designated as safety issue: No ]
    Primary or repeat cesarean delivery

  • Diagnosis of gestational diabetes [ Time Frame: Will be followed from study enrollment until delivery (approximately 40 weeks' gestation) ] [ Designated as safety issue: No ]
    Assess how frequently a diagnosis of gestational diabetes is made


Secondary Outcome Measures:
  • Pre-eclampsia or gestational hypertension [ Time Frame: Will be assessed from study enrollment until 30 days after delivery ] [ Designated as safety issue: No ]
    New onset hypertension +/- proteinuria

  • Neonatal hypoglycemia [ Time Frame: First 24 hours of life ] [ Designated as safety issue: No ]
    Defined as blood glucose less than 80 mg/dL from heel stick within 1 hour after delivery

  • Neonatal hyperbilirubinemia [ Time Frame: First 7 days of life ] [ Designated as safety issue: No ]
    Defined as bilirubin greater than 5 mg/dL over 24 hours from heel stick

  • Infant birth trauma [ Time Frame: Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation) ] [ Designated as safety issue: No ]
    Defined as shoulder dystocia/brachial plexus injuries

  • Maternal birth trauma [ Time Frame: Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation) ] [ Designated as safety issue: No ]
    3rd or 4th degree perineal laceration or postpartum hemorrhage


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540396

Locations
United States, Pennsylvania
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Christina M Scifres, MD University of Pittsburgh
Principal Investigator: Esa Davis, MD MPH University of Pittsburgh
  More Information

No publications provided

Responsible Party: Christina Scifres, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01540396     History of Changes
Other Study ID Numbers: PRO11080682
Study First Received: February 15, 2012
Last Updated: June 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Gestational Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on April 15, 2014