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NCT03433040 · ClinicalTrials.gov registry record · Phase 3
17OHP-C Dosing Among Obese Pregnant Women
A Phase 3 study of Premature Birth and Absorption; Chemicals, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 3
- Development phase
- 44
- Enrollment target
- 2
- Study locations
NCT03433040: Completed Phase 3 study of Premature Birth and Absorption; Chemicals, sponsored by University of South Florida.
NCT03433040 is a Phase 3 study of Premature Birth and Absorption; Chemicals that has completed, run by University of South Florida. The registered enrollment target is 44 participants, below the 393-participant average among 38 other Premature Birth trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03433040, a Phase 3 study of Premature Birth and Absorption; Chemicals, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 44 participants
- Enrollment target
- 2
- Study locations
Study Summary
Emergency data suggest 17OHP-C may be less efficacious in obese women. Since obesity is associated with lower levels of plasma 17OHP-C, the investigator hypothesize that higher doses of 17OHP-C may help to prevent spontaneous PTB among obese women. The study aims to compare the pharmacokinetics of 17 OHP-C in obese compared with non-obese women.
Primary Outcome
Blood levels
Conditions Studied
Interventions
- DRUG 17-Hydroxyprogesterone Capronate
Study Locations (2)
Florida
- University of South Florida - Tampa
Missouri
- Washington University in St Louis - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2017-08-23 |
| Est. Completion | 2021-07-14 |
| Phase | Phase 3 |
What the finished NCT03433040 record still lists
NCT03433040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 393-participant average among 38 other Premature Birth trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Premature Birth appearing as the primary indexed condition, and to 1 intervention - of which 17-Hydroxyprogesterone Capronate is the first listed.
NCT03433040 reports a single indexed study location in Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT03433040 about?
NCT03433040 is a clinical study titled "17OHP-C Dosing Among Obese Pregnant Women". Emergency data suggest 17OHP-C may be less efficacious in obese women. Since obesity is associated with lower levels of plasma 17OHP-C, the investigator hypothesize that higher doses of 17OHP-C may help to prevent spontaneous PTB among obese women. The study aims to compare the pharmacokinetics of 1...
What is the current status of trial NCT03433040?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 44 participants. The study started on 2017-08-23. Estimated completion is 2021-07-14.
What conditions does trial NCT03433040 study?
This clinical trial studies the following conditions: Premature Birth, Absorption; Chemicals.
What interventions are being tested in trial NCT03433040?
The interventions under investigation include: 17-Hydroxyprogesterone Capronate (DRUG).
Who is sponsoring clinical trial NCT03433040?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03433040 being conducted?
This trial has 2 study locations across Florida, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03433040's enrollment target sits among peer trials
44 33rd of 38 higher than 6 of 38 other Premature Birth trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Premature Birth 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.
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