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NCT03527537 · ClinicalTrials.gov registry record · Phase 4
Gestational Diabetes and Pharmacotherapy (GAP)
A Phase 4 study of Gestational Diabetes, sponsored by Medical College of Wisconsin.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 416
- Enrollment target
- 1
- Study location
NCT03527537: Recruiting Phase 4 study of Gestational Diabetes, sponsored by Medical College of Wisconsin.
NCT03527537 is a Phase 4 study of Gestational Diabetes that is actively recruiting participants, run by Medical College of Wisconsin. The registered enrollment target is 416 participants, above the 312-participant average among 41 other Gestational Diabetes trials with a reported enrollment target (33% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03527537, a Phase 4 study of Gestational Diabetes, is actively recruiting participants, sponsored by Medical College of Wisconsin.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 416 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to compare two different thresholds for initiation of medical treatment for GDM. Pregnant women diagnosed with GDM will be randomized to either start pharmacotherapy when they have reached at least 20% or at least 40% of capillary blood glucose (CBG) values above the target goal. The investigators hypothesize that a lower threshold of 20% elevated CBG levels, compared to 40%, will lead to lower rates of obstetric and medical complications.
Primary Outcome
Our primary outcome will be a composite adverse neonatal outcome associated with gestational diabetes: large-for-gestational age macrosomia birth trauma preterm birth neonatal hypoglycemia hyperbilirubinemia
Conditions Studied
Interventions
- DRUG Insulin
Study Locations (1)
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 416 participants |
| Start Date | 2021-05-04 |
| Est. Completion | 2026-10-01 |
| Phase | Phase 4 |
What NCT03527537 shows while recruiting
NCT03527537 is an interventional study that assigns participants to a tested intervention. The registered 416 participants enrollment target is mid-sized for trials with a published cap, above the 312-participant average among 41 other Gestational Diabetes trials with a reported enrollment target (33% higher).
The record links to 1 condition, with Gestational Diabetes appearing as the primary indexed condition, and to 1 intervention - of which Insulin is the first listed.
NCT03527537 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03527537 about?
NCT03527537 is a clinical study titled "Gestational Diabetes and Pharmacotherapy (GAP)". The goal of this study is to compare two different thresholds for initiation of medical treatment for GDM. Pregnant women diagnosed with GDM will be randomized to either start pharmacotherapy when they have reached at least 20% or at least 40% of capillary blood glucose (CBG) values above the target...
What is the current status of trial NCT03527537?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 416 participants. The study started on 2021-05-04. Estimated completion is 2026-10-01.
What conditions does trial NCT03527537 study?
This clinical trial studies the following conditions: Gestational Diabetes.
What interventions are being tested in trial NCT03527537?
The interventions under investigation include: Insulin (DRUG).
Who is sponsoring clinical trial NCT03527537?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03527537 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gestational Diabetes
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 NCT03527537's enrollment target sits among peer trials
416 9th of 41 higher than 33 of 41 other Gestational Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gestational Diabetes 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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