Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care

Study acronym: EleVATE GC
StatusCompleted
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial completed
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 8 of 16 entries
    • Site details revised at 1 of 4 sites
  2. Re-verified, no change to tracked fieldsv10
  3. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 390 to confirmed 416
    • Primary completion date changed from estimate of Jun 30, 2025 to Dec 3, 2025
    • Study completion date: Jun 30, 2025 to Jun 30, 2026
    v9
  4. 2 versions Re-verified since Nov 28, 2023, no change to tracked fieldsv7-v8
  5. Eligibility criteria expanded, about 12 wordsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Enrollment target: 330 to 390v5
  2. Start date: Jul 1, 2021 to May 21, 2021v4
  3. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Primary and study completion dates: Aug 2025 to Jun 30, 2025
    • Start date changed from estimate of May 2021 to Jul 1, 2021
    • Site contacts updated at 4 of 4 sites
    v3
  4. Secondary endpoints: details revised at 1 of 16 entriesv2
  1. Study First Submitted
  • 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 study will provide high-quality, representative data on the capacity of Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care (EleVATE GC) to reduce perinatal depression, preterm birth, and low birthweight in African-American women. If findings from this study indicate that EleVATE GC is feasible and effective, this model could be implemented nationwide to help achieve mental and obstetric health parity for low-income women of color in the United States.
Trial Details
NCT Number NCT04838210
Lead Sponsor Washington University School of Medicine
Conditions
(from sponsor)		 Pregnancy Related, Perinatal Depression
Enrollment 416 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov