Actively Recruiting
Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes
Led by Thomas Jefferson University · Updated on 2024-11-21
430
Participants Needed
2
Research Sites
86 weeks
Total Duration
On this page
Sponsors
T
Thomas Jefferson University
Lead Sponsor
U
University of Rochester
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a strict and permissive threshold. The strict threshold is defined as two abnormal values or more over a one-week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated), whereas the permissive threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values).
CONDITIONS
Official Title
Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Live, non-anomalous fetus
- Literacy in English, Spanish, Mandarin, or Arabic
- Willingness to provide consent, understand the study purpose, and follow the study protocol
You will not qualify if you...
- Under 18 years old at estimated due date
- Pre-existing diabetes or gestational diabetes diagnosed before 24 weeks
- Multiple pregnancies (twins or more)
- Known major fetal anomaly
- Known allergy to insulin
- Chronic use of corticosteroids by the mother
- Gestational diabetes diagnosed only by finger stick tests
- Contraindication to oral glucose tolerance test
- Primary language other than English, Spanish, Mandarin, or Arabic
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Rochester Medical Center
Rochester, New York, United States, 14642
Not Yet Recruiting
2
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
K
Kavisha Khanuja, MD
CONTACT
R
Rodney McLaren Jr, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here