Gestational Diabetes Diagnostic Methods

NCT01540396 | Completed DMC

• 1 other identifier: PRO11080682
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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).

Conditions

Gestational Diabetes

Keywords

Gestational Diabetes

Outcome Measures

Primary Outcomes (3)

• Macrosomia

  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

  Primary or repeat cesarean delivery

  Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)

• Diagnosis of gestational diabetes

  Assess how frequently a diagnosis of gestational diabetes is made

  Will be followed from study enrollment until delivery (approximately 40 weeks' gestation)

Secondary Outcomes (5)

• Pre-eclampsia or gestational hypertension

  Will be assessed from study enrollment until 30 days after delivery

• Neonatal hypoglycemia

  First 24 hours of life

• Neonatal hyperbilirubinemia

  First 7 days of life

• Infant birth trauma

  Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)

• Maternal birth trauma

  Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)

Study Arms (2)

75 Gram OGTT

ACTIVE COMPARATOR

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

Behavioral: Dietary modification and medications

100 gram OGTT

ACTIVE COMPARATOR

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

Interventions

Dietary modification and medications BEHAVIORAL

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.

100 gram OGTT; 75 Gram OGTT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Diet Therapy; Dosage Forms

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Christina M Scifres, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Esa Davis, MD MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: February 28, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: December 1, 2014
• Last Updated: February 4, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)