Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThomas Jefferson University

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

<18 years at EDD

pre-existing diabetes or diagnosis of GDM before 24 weeks

multi-fetal gestation

known major fetal anomaly

Trial design

Treatments tested in this trial

  • Insulin

Treatment groups

430 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Thomas Jefferson University

Lead sponsor

University of Rochester

Collaborator