Gestational Diabetes Diagnostic Methods

Gestational Diabetes Clinical Trial

— GD2M  

Official title:

GD2M Study:Gestational Diabetes Diagnostic Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540396
• Other study ID #: PRO11080682
• Status: Completed
• Phase: N/A
• First received: February 15, 2012
• Last updated: February 2, 2016
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Magee-Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	Cesarean delivery	Primary or repeat cesarean delivery	Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)	No
Primary	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)	No
Secondary	Pre-eclampsia or gestational hypertension	New onset hypertension +/- proteinuria	Will be assessed from study enrollment until 30 days after delivery	No
Secondary	Neonatal hypoglycemia	Defined as blood glucose less than 80 mg/dL from heel stick within 1 hour after delivery	First 24 hours of life	No
Secondary	Neonatal hyperbilirubinemia	Defined as bilirubin greater than 5 mg/dL over 24 hours from heel stick	First 7 days of life	No
Secondary	Infant birth trauma	Defined as shoulder dystocia/brachial plexus injuries	Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)	No
Secondary	Maternal birth trauma	3rd or 4th degree perineal laceration or postpartum hemorrhage	Will be assessed from study enrollment until delivery (approximtaly 40 weeks' gestation)	No