Trials
Search / Trial NCT06419777

Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes

Launched by THOMAS JEFFERSON UNIVERSITY · May 14, 2024

Trial Information

Current as of February 12, 2025

Recruiting

Keywords

Gestational Diabetes Pregnancy Insulin Initiation Of Medication

ClinConnect Summary

This clinical trial is studying how different ways of deciding when to start medication for gestational diabetes (GDM) affect the health of mothers and their newborns. The researchers want to compare two approaches: a strict method that requires more abnormal test results before starting treatment, and a more flexible method that allows treatment based on fewer abnormal results. By understanding how these different thresholds impact outcomes, the goal is to find the best way to manage GDM during pregnancy.

To participate in this study, you need to be a woman with a live, healthy pregnancy and able to read in English, Spanish, Mandarin, or Arabic. You must also be willing to give your consent and understand the study's purpose. If you are under 18, have diabetes before the pregnancy, are carrying more than one baby, or have certain other health issues, you may not be eligible. Participants will be closely monitored during the study, and your experiences will help improve care for future mothers with gestational diabetes.

Gender

FEMALE

Eligibility 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

About Thomas Jefferson University

Thomas Jefferson University is a distinguished academic institution located in Philadelphia, Pennsylvania, renowned for its commitment to advancing healthcare through research and education. As a clinical trial sponsor, the university leverages its extensive resources and interdisciplinary expertise to conduct innovative research aimed at improving patient outcomes. With a focus on translational medicine, Thomas Jefferson University collaborates with various stakeholders, including healthcare professionals, industry partners, and regulatory agencies, to ensure the highest standards of scientific rigor and ethical conduct in its clinical trials. The institution is dedicated to fostering a culture of excellence in research, ultimately contributing to the advancement of medical knowledge and the development of novel therapeutic interventions.

Locations

Rochester, New York, United States

Philadelphia, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0