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Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational Diabetes
NCT04542148 · View on ClinicalTrials.gov ↗
Study Summary
There is a fundamental gap in understanding the maternal and neonatal effects of antenatal corticosteroid (ACS) administration in women with threatened preterm birth (PTB) who have diabetes. Since the initial discovery of ACS for neonatal benefit in 1972, more than 40 randomized controlled trials have been performed evaluating its efficacy. However, none of these trials have included women with T2DM, and there is limited data among women with gestational diabetes. While ACS have been shown to reduce neonatal morbidity associated with PTB in non-diabetic women, the side effects of ACS (maternal hyperglycemia and fetal hyperinsulinemia) may mitigate the neonatal benefit of ACS in women with diabetes. Before neonatal benefit of ACS can be evaluated in this population, the first step is to optimize maternal glycemic control after ACS. Previous studies evaluating maternal hyperglycemia after ACS have been limited by small sample size, retrospective study design, or insufficient glucose data. Use of continuous glucose monitoring (CGM) in a randomized clinical trial provides a unique opportunity to overcome these challenges. Our long-term goal is to improve maternal and child health among women with diabetes as an independently funded clinical researcher. The research objectives of this proposal are to test the efficacy of three treatment strategies at achieving maternal glycemic control after ACS and evaluate the association between maternal glycemic control and neonatal outcomes. Our central hypothesis is that treatment with a continuous insulin infusion will improve maternal glycemic control, which is key to improving neonatal outcomes, but at the cost of less patient satisfaction and more health resource utilization. This hypothesis will be tested by pursuing the following specific aims: 1) Test the efficacy of three treatment strategies (addition of sliding scale insulin, up-titration of home insulin, and continuous insulin infusion) at achieving maternal glycemic con
Conditions Studied
Interventions
- DRUG Sliding Scale Insulin
- DRUG Up-Titration of Home Insulin
- DRUG Continuous Insulin Infusion
- DEVICE Dexcom G6 Professional Continuous Glucose Monitor
Study Locations (4)
Alabama
- University of Alabama at Birmingham — Birmingham
Oregon
- Oregon Health and Science University — Portland
South Carolina
- University of South Carolina Greenville / Prisma Health-Upstate — Greenville
Texas
- University of Texas Health Science Center at Houston — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-02-10 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04542148
The ClinicalTrials.gov registry entry for NCT04542148 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 4 interventions — of which Sliding Scale Insulin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04542148 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Alabama, Oregon, South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04542148 about?
NCT04542148 is a clinical study titled "Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational Diabetes". There is a fundamental gap in understanding the maternal and neonatal effects of antenatal corticosteroid (ACS) administration in women with threatened preterm birth (PTB) who have diabetes. Since the initial discovery of ACS for neonatal benefit in 1972, more than 40 randomized controlled trials ha...
What is the current status of trial NCT04542148?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2022-02-10. Estimated completion is 2026-05-31.
What conditions does trial NCT04542148 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Preterm Birth, Pregnancy, High Risk, Diabetes, Gestational. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04542148?
The interventions under investigation include: Sliding Scale Insulin (DRUG), Up-Titration of Home Insulin (DRUG), Continuous Insulin Infusion (DRUG), Dexcom G6 Professional Continuous Glucose Monitor (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04542148?
This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04542148 being conducted?
This trial has 4 study locations across Alabama, Oregon, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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