NCT06008561

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Oct 2023Dec 2026

First Submitted

Initial submission to the registry

August 11, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 31, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2026

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

August 11, 2023

Last Update Submit

March 19, 2026

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Gestational Age in weeks

    Through study completion, an average of 2 years

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We will recruit 100 pregnant women prior to their 29th week of gestation from Sanford Health prenatal care providers in the Fargo, North Dakota, and Sioux Falls, South Dakota greater metropolitan areas.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sanford Health

Fargo, North Dakota, 58104, United States

RECRUITING

Sanford Health

Sioux Falls, South Dakota, 57104, United States

RECRUITING

Study Officials

  • Anna M Strahm, PhD

    Sanford Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace Biermann, MPH

CONTACT

6053126457strahmlab@sanfordhealth.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2023

First Posted

August 23, 2023

Study Start

October 31, 2023

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

December 20, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)