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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 is a Phase 2 study that has completed, run by Materna Medical. The registered enrollment target is 214 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06126328
The ClinicalTrials.gov registry entry for NCT06126328 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 214 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Materna Medical, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Materna Prep Device is the first listed.
NCT06126328 reports 0 study locations.
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.
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