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Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage

Study acronym: NOVIC
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 21, 2023 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2023 to Oct 23, 2023
    • Site details revised at 2 of 2 sites
    v4
  2. Notable Start date: Sep 1, 2022 to Aug 1, 2023v3
  3. Minor Secondary endpoints revised (13)
    • Study title shortened, about 4 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This will be the first, definitive, randomized control trial (N=424) to test the hypothesis that the Jada® System is effective, safe and cost-effective in treating PPH, compared to standard care.
Trial Details
NCT Number NCT05382403
Lead Sponsor Women and Infants Hospital of Rhode Island
Collaborators: Washington University School of Medicine, University of Ghana, Kwame Nkrumah University of Science and Technology
Conditions
(from sponsor)
Postpartum Hemorrhage, Maternal Death
Related terms Maternal Death, Postpartum Hemorrhage
Enrollment 424 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov