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Midwest Birth Outcomes and Indigenous American Pregnancy

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary and study completion dates: Dec 31, 2025 to Dec 20, 2026
    • Site contacts updated at 2 of 2 sites
    v5
  2. Primary completion date: Jul 31, 2025 to Dec 31, 2025
    • Study completion date: Nov 30, 2025 to Dec 31, 2025
    • Site contacts updated at 2 of 2 sites
    v4
  3. Study sites: 1 to 2v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Eligibility criteria revised
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Indigenous American pregnancies in the Midwest have disproportionally high rates of adverse outcomes, however little research has been done on how historical trauma and stress may impact these adverse outcomes. This project gathers data from pregnant Indigenous American women on their experiences with historical trauma, stress, and birth outcomes, as well as physiological data of how they respond to stress, in order to better understand the associations between these factors and the biological mechanisms underlying them. Understanding the mechanisms by which both historical and proximal stress "get under the skin" and influence pregnancy health and perinatal outcomes, will afford new targets of intervention to help reduce these IA health disparities.
Trial Details
NCT Number NCT06008561
Lead Sponsor Sanford Health
Collaborators: National Institute of General Medical Sciences (NIGMS)
Conditions
(from sponsor)		 Pregnancy
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov