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Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes

RecruitingNAAges 18 Years - anyFemaleThomas Jefferson University
NCT06419777 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
Inclusion Criteria: * Live, non-anomalous fetus * Literacy in English, Spanish, Mandarin, or Arabic * Patients are also required to provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol. Exclusion Criteria: * \<18 years at EDD * pre-existing diabetes or diagnosis of GDM before 24 weeks * multi-fetal gestation * known major fetal anomaly * known allergy to insulin * chronic maternal corticosteroid use * diagnosis of GDM based on finger sticks alone * patients who have contraindication to oral glucose tolerance test * a primary language other than English, Spanish, Mandarin, or Arabic
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What it tests

  • Insulin
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Where

2 sites
University of Rochester Medical Center
Rochester, United States
Thomas Jefferson University
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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