Status:
WITHDRAWN
Early Intervention for Gestational Diabetes
Lead Sponsor:
Intermountain Health Care, Inc.
Conditions:
Gestational Diabetes Mellitus
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Gestational diabetes (GDM) represents a significant and growing source nationwide of morbidity and mortality for both mothers and infants. Between 5 and 10% of pregnancies are complicated by GDM. Infa...
Eligibility Criteria
Inclusion
- Women delivered \>37 weeks gestation in the Intermountain Healthcare Urban Central Region within the last 18 months to ascertain those at risk for GDM in their next pregnancy because of:
- A history of gestational diabetes in their immediately prior pregnancy
- A family history (i.e. type 2 diabetes in a first or second degree relative) of type 2 diabetes
- Delivery of an infant \> 4000 gms.
- B.M.I. \> 30 six months postpartum
- Hemoglobin A1C \> 6.1% six months postpartum
Exclusion
- Pre-conception exclusion criteria will include any of the following:
- History of \>1 miscarriage or fetal demise
- No contraindication to metformin (prior metformin intolerance, metabolic acidosis, GI disease)
- Hypertension (BP \>135/85)
- No other endocrine, metabolic, renal, or autommune medical disorders
- Prior preterm birth
- Prior delivery complicated by shoulder dystocia
- Prior delivery complicated by neonatal palsy
- Multifetal pregnancy, including first-trimester embryonic demise of one or more
- Uterine malformations
- Illicit drug or alcohol abuse during current pregnancy
- Intent to deliver elsewhere
- Non-availability for prospective specimen/data collection
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01171456
Start Date
April 1 2010
End Date
July 1 2010
Last Update
January 16 2013
Active Locations (1)
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1
Intermountain Medical Center
Murray, Utah, United States, 84107