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NCT06126328 · ClinicalTrials.gov registry record · Phase 2
Materna Prep Study Phase II
A Phase 2 study, sponsored by Materna Medical.
- Completed
- Registry status
- Phase 2
- Development phase
- 214
- Enrollment target
NCT06126328: Completed Phase 2 study, sponsored by Materna Medical.
NCT06126328 is a Phase 2 study that has completed, run by Materna Medical. The registered enrollment target is 214 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06126328, a Phase 2 study, has completed, sponsored by Materna Medical.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 214 participants
- Enrollment target
Study Summary
This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery. Subjects are randomized to Materna Prep Device or Standard of Care without use of the Materna Prep Device Intervention with the Materna Prep Device is expected to be a one-time use of approximately 30-90 minutes during the 1st stage of labor. Subject participation in the study is targeted to be 3 months from the time of the use of the device during delivery with optional long-term follow-up.
Primary Outcome
Use transperineal ultrasound to identify levator ani muscle detachment
Interventions
- DEVICE Materna Prep Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2021-09-08 |
| Est. Completion | 2023-10-12 |
| Phase | Phase 2 |
What the finished NCT06126328 record still lists
NCT06126328 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% higher).
The record links to 0 conditions, and to 1 intervention - of which Materna Prep Device is the first listed.
NCT06126328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06126328 about?
NCT06126328 is a clinical study titled "Materna Prep Study Phase II". This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery. Subjects are randomized to Materna Prep Device or Standard of Care without use of the Materna Prep Device Intervention with the Materna Prep Device...
What is the current status of trial NCT06126328?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 214 participants. The study started on 2021-09-08. Estimated completion is 2023-10-12.
What interventions are being tested in trial NCT06126328?
The interventions under investigation include: Materna Prep Device (DEVICE).
Who is sponsoring clinical trial NCT06126328?
This trial is sponsored by Materna Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06126328's enrollment target sits among peer trials
214 290th of 2000 higher than 1,711 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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