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NCT06419777 · ClinicalTrials.gov registry record · NA
Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes
A NA study of Pregnancy Related and Gestational Diabetes, sponsored by Thomas Jefferson University.
- Recruiting
- Registry status
- NA
- Development phase
- 430
- Enrollment target
- 2
- Study locations
NCT06419777: Recruiting NA study of Pregnancy Related and Gestational Diabetes, sponsored by Thomas Jefferson University.
NCT06419777 is a NA study of Pregnancy Related and Gestational Diabetes that is actively recruiting participants, run by Thomas Jefferson University. The registered enrollment target is 430 participants, below the 1,959-participant average among 99 other Pregnancy Related trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06419777, a NA study of Pregnancy Related and Gestational Diabetes, is actively recruiting participants, sponsored by Thomas Jefferson University.
- RECRUITING
- Registry status
- NA
- Development phase
- 430 participants
- Enrollment target
- 2
- Study locations
Study Summary
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).
Primary Outcome
neonatal composite including the following measures: large for gestational age (LGA) of neonate defined as birth weight \>90th percentile for gestational age using the Fenton growth chart, hypoglycemia o defined as glucose \<40 mg/dL \<48 hours after birth or glucose, hyperbilirubinemia, stillbirth or neonatal death, birth trauma
Conditions Studied
Interventions
- DRUG Insulin
Study Locations (2)
New York
- University of Rochester Medical Center - Rochester
Pennsylvania
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430 participants |
| Start Date | 2024-09-01 |
| Est. Completion | 2026-05 |
| Phase | NA |
What NCT06419777 shows while recruiting
NCT06419777 is an interventional study that assigns participants to a tested intervention. The registered 430 participants enrollment target is mid-sized for trials with a published cap, below the 1,959-participant average among 99 other Pregnancy Related trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Pregnancy Related appearing as the primary indexed condition, and to 1 intervention - of which Insulin is the first listed.
NCT06419777 reports a single indexed study location in New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06419777 about?
NCT06419777 is a clinical study titled "Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes". 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 ov...
What is the current status of trial NCT06419777?
This trial is currently recruiting. It is a NA study. The enrollment target is 430 participants. The study started on 2024-09-01. Estimated completion is 2026-05.
What conditions does trial NCT06419777 study?
This clinical trial studies the following conditions: Pregnancy Related, Gestational Diabetes.
What interventions are being tested in trial NCT06419777?
The interventions under investigation include: Insulin (DRUG).
Who is sponsoring clinical trial NCT06419777?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06419777 being conducted?
This trial has 2 study locations across New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy Related
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06419777's enrollment target sits among peer trials
430 31st of 99 higher than 68 of 99 other Pregnancy Related trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy Related trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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