Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT01171456
Eligibility Criteria:
Inclusion Criteria:
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 Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01171456
Study Brief:
Protocol Section:
NCT01171456