Recruiting

Observational Study

Sponsor:

Sanford Health

Code:

NCT06008561

Conditions

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Pregnancy

Study ID

NCT06008561

Start date

Oct 31, 2023

Status verified date

Mar, 2026

Completion date

Dec 20, 2026

Anticipated

Primary completion date

Dec 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • At least 18 years old
  • Less than 26 weeks
  • Healthy single baby pregnancy
  • Indigenous American

Exclusion Criteria:

  • Assistive reproductive technology (in-vitro fertilization)
  • Have a history of cardiac and endocrine disease

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Gestational Age in weeks [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Locations

Sanford Health

Recruiting

Fargo, North Dakota, United States, 58104

Contacts

Principal Investigator:

Anna M Strahm

Sanford Health

Recruiting

Sioux Falls, South Dakota, United States, 57104

Contacts

Principal Investigator:

Anna M Strahm, PhD

More Information

Sponsor

Sanford Health

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sanford Health on 2026-03-20.