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Rhode Island - Statewide Postpartum Hypertension Remote Surveillance

Study acronym: RI-SPHERES
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date: Apr 14, 2025 to Apr 15, 2025
    • Site details revised at 1 of 5 sites
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2025 to Apr 14, 2025
    • Site details revised at 5 of 5 sites
    v3
  3. Primary completion date: May 1, 2028 to Mar 1, 2029
    • Study completion date: May 1, 2029 to Mar 1, 2029
    • Start date: May 1, 2025 to Apr 1, 2025
    • Secondary endpoints revised (14)
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a hybrid type 1 non-inferiority implementation effectiveness trial among postpartum patients with hypertension (N=1536) that will test the hypothesis that RI-SPHERES (a technologically enabled collaborative care model) is non-inferior to a standard self-measured blood pressure program in terms of persistent hypertension at six weeks postpartum and preventive care receipt within one year of delivery.
Trial Details
NCT Number NCT06842875
Lead Sponsor Women and Infants Hospital of Rhode Island
Collaborators: Brown University, Kent Hospital, Rhode Island
Conditions
(from sponsor)		 Hypertension in Pregnancy, Postpartum Preeclampsia, Postpartum Complication
Related terms Hypertension, Pregnancy-Induced
Enrollment 1,536 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov