PregnancyNCT06008561
Midwest Birth Outcomes and Indigenous American Pregnancy
An observational study of Pregnancy, run by Sanford Health at 2 sites in United States.
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.
United States2 sites, 2 recruiting
- 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
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.
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.
- First posted23 Aug 2023
- Study start31 Oct 2023
- Primary completion20 Dec 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Anna M Strahm, PhD, Principal investigator, Sanford Health
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midwest Birth Outcomes and American Indian Pregnancy: Associations With Historical Trauma and Psychosocial Stress
- ClinicalTrials.gov ID
- NCT06008561
- Acronym / sponsor ID
- SH MBOIAP23
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- At least 18 years old
- Less than 26 weeks
- Healthy single baby pregnancy
- Indigenous American
Key exclusion criteria (2 listed)
- Assistive reproductive technology (in-vitro fertilization)
- Have a history of cardiac and endocrine disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gestational Age in weeks
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna M Strahm, PhD principal investigator
Sanford Health
2 sites in 1 country: see every site and its status.
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.