deltatrials
Active Not Recruiting NA INTERVENTIONAL 2-arm NCT03973281

EASE: The Materna Prep Pivotal Study

A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the Materna Prep Device to Pre-stretch the Vaginal Canal and Pelvic Floor Tissues in Preparation for Vaginal Delivery

Sponsor: Materna Medical

Conditions Pelvic Organ Prolapse Vaginal Delivery
Interventions Materna Prep Device Standard of Care (SOC)
Updated 19 times since 2019 Last updated: Sep 16, 2025 Started: Dec 11, 2019 Primary completion: Jul 30, 2026 Completion: Aug 30, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Pelvic Organ Prolapse and Vaginal Delivery and is currently ongoing. Materna Medical leads this study, which shows 19 recorded versions since 2019 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Jan 2020 · 5 months · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Sep 2021 · 6 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Apr 2022 · 6 months · monthly snapshot~Apr 2022 – ~Sep 2022 · 5 months · monthly snapshot~Sep 2022 – ~Apr 2023 · 7 months · monthly snapshot~Apr 2023 – ~Jul 2023 · 3 months · monthly snapshot~Jul 2023 – ~Sep 2023 · 2 months · monthly snapshot~Sep 2023 – ~Nov 2023 · 2 months · monthly snapshot~Nov 2023 – ~Jul 2024 · 8 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Aug 2025 · 11 months · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – present · 9 months · monthly snapshot

Change History

19 versions recorded

  1. Oct 2025 — Present [monthly]

    Active Not Recruiting NA

  2. Sep 2025 — Oct 2025 [monthly]

    Active Not Recruiting NA

    Status: Recruiting → Active Not Recruiting

  3. Aug 2025 — Sep 2025 [monthly]

    Recruiting NA

  4. Sep 2024 — Aug 2025 [monthly]

    Recruiting NA

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting NA

▶ Show 14 earlier versions

  1. Nov 2023 — Jul 2024 [monthly]

    Recruiting NA

  2. Sep 2023 — Nov 2023 [monthly]

    Recruiting NA

  3. Jul 2023 — Sep 2023 [monthly]

    Recruiting NA

  4. Apr 2023 — Jul 2023 [monthly]

    Recruiting NA

  5. Sep 2022 — Apr 2023 [monthly]

    Recruiting NA

  6. Apr 2022 — Sep 2022 [monthly]

    Recruiting NA

  7. Oct 2021 — Apr 2022 [monthly]

    Recruiting NA

  8. Sep 2021 — Oct 2021 [monthly]

    Recruiting NA

    Phase: PHASE2 → NA

  9. Mar 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

  10. Jan 2021 — Mar 2021 [monthly]

    Recruiting PHASE2

  11. Feb 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  12. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  13. Aug 2019 — Jan 2020 [monthly]

    Not Yet Recruiting PHASE2

    Phase: NA → PHASE2

  14. Jul 2019 — Aug 2019 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Materna Medical
  • University of Michigan
Data source: Materna Medical

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Birmingham, United States , Camden, United States , Cleveland, United States , Columbus, United States , Flushing, United States , Greenbrae, United States , Houston, United States , Idaho Falls, United States , League City, United States , Los Angeles, United States and 10 more locations