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Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes

Thomas Jefferson University · with University of Rochester · NCT06419777

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
430
US sites recruiting
1
Study start
September 1, 2024
Record last updated
November 21, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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).

Being studied: Insulin

Conditions: Gestational Diabetes; Pregnancy Related

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Thomas Jefferson University

    Philadelphia, PA 19107

    Site contact: Kavisha Khanuja, MD

Study contacts (from the official record)

  • Kavisha Khanuja, MD · 215-955-5000 · kxk334@jefferson.edu
  • Rodney McLaren Jr, MD · 215-955-5000 · rodney.mclaren@jefferson.edu
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