- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06008561
Midwest Birth Outcomes and Indigenous American Pregnancy
January 22, 2024 updated by: Sanford Health
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Valentina Ayala Catalan
- Phone Number: 6053126406
- Email: strahmlab@sanfordhealth.org
Study Locations
-
-
North Dakota
-
Fargo, North Dakota, United States, 58104
- Recruiting
- Sanford Health
-
Contact:
- Valentina Ayala Catalan
- Phone Number: 605-312-6406
- Email: valentina.ayalacatalan@sanfordhealth.org
-
Principal Investigator:
- Anna M Strahm
-
-
South Dakota
-
Sioux Falls, South Dakota, United States, 57104
- Recruiting
- Sanford Health
-
Contact:
- Valentina Ayala Catalan
- Phone Number: 605-312-6406
- Email: valentina.ayalacatalan@sanfordhealth.org
-
Principal Investigator:
- Anna M Strahm, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gestational Age in weeks
Time Frame: Through study completion, an average of 2 years
|
Through study completion, an average of 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Anna M Strahm, PhD, Sanford Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 31, 2023
Primary Completion (Estimated)
July 31, 2025
Study Completion (Estimated)
November 30, 2025
Study Registration Dates
First Submitted
August 11, 2023
First Submitted That Met QC Criteria
August 22, 2023
First Posted (Actual)
August 23, 2023
Study Record Updates
Last Update Posted (Actual)
January 23, 2024
Last Update Submitted That Met QC Criteria
January 22, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- SH MBOIAP23
- 5P20GM121341-05 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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