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PregnancyNCT06008561

Midwest Birth Outcomes and Indigenous American Pregnancy

An observational study of Pregnancy, run by Sanford Health at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
How many people
80 participants
Where
2 sitesUnited States
Study dates
31 Oct 2023to 20 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Grace Biermann, MPH contact

6053126457

strahmlab@sanfordhealth.org

United States2 sites, 2 recruiting
  • Sanford Health

    Fargo, North Dakota, 58104

    Grace Biermann, MPH, 605-312-6457, grace.biermann@sanfordhealth.org

    Anna M Strahm

    Recruiting
  • Sanford Health

    Sioux Falls, South Dakota, 57104

    Grace Biermann, MPH, 605-312-6457, grace.biermann@sanfordhealth.org

    Anna M Strahm, PhD

    Recruiting

Other trials in United States

About this study

Official title: Midwest Birth Outcomes and American Indian Pregnancy: Associations With Historical Trauma and Psychosocial Stress

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.

Read the detailed description

As the U.S. Healthy People 2030 Objectives include reducing rates of infant mortality from 5.4 to 5.0 live births per 1000, and preterm births from 10.1% to 9.6%, Indigenous American (IA) women in the Midwest continue to experience disproportionately high rates of infant mortality (8.8 per 1000 live births) and preterm birth (12.8%). Identified risk factors, such as diet and access to healthcare, do not fully explain these persistent perinatal-health disparities. Therefore, studies have begun to focus on culturally-relevant psychosocial stressors such as historical trauma to try to understand he occurrence of adverse pregnancy outcomes. Although a history of deculturation, devalued status, and reduced resources may have long reaching impact, affecting new generations of IA women and their pregnancies, there is a paucity of psychosocial research on IA perinatal health. It is imperative that associations among IA historical trauma, proximal stressors, and physiological stress responses during pregnancy are better understood to develop more effective interventions that can improve IA perinatal health. Historical trauma may contribute to IA perinatal health disparities by increasing the frequency and intensity of proximal stressors, including experiences of racism and socioenvironmental stress in general, and by influencing psychophysiological responses to stress. The investigators hypothesize that interactions among historical trauma, proximal stress and physiological responses to acute stress will predict length of gestation and birth weight for IA women. This project will: 1) determine if historical trauma is associated with IA women's psychophysiological responses to acute stress during pregnancy; 2) identify the degree to which historical trauma is associated with increased risks of adverse pregnancy health and perinatal outcomes in IA pregnancies; and 3) examine how historical trauma, psychophysiological responses to stress, and proximal maternal stress may interact to predict adverse perinatal outcomes in IA pregnancies. To examine these interactions, the investigators will recruit 100 pregnant IA women from Sanford Health prenatal care providers to complete a lab visit between 23-28 weeks of pregnancy. While at the lab they will 1) participate in a standardized laboratory psychophysiological challenge task while blood pressure and heart rate are recorded and saliva is collected to assess cortisol, immunoglobulin A, and c-reactive protein responses; 2) complete standardized surveys on historical trauma, and proximal stress, mental and general health, and wellness behaviors; and 3) provide consent to access medical records pertaining to prior and current pregnancy health and perinatal outcomes. 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gestational Age in weeks

    Measured: Through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study start31 Oct 2023
  3. Primary completion20 Dec 2027 (estimated)
  4. Study completion20 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06008561
Sponsor's protocol ID
SH MBOIAP23
Other IDs
5P20GM121341-05
Status last verified
Mar 2026
First submitted
11 Aug 2023
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy, run by Sanford Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Grace Biermann, MPH (6053126457, strahmlab@sanfordhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gestational Age in weeks (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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