PregnancyNCT06718907
Mitigating Response to Stressors in Pregnant Women
A study testing Simulated stimuli and Stress Management in people with Pregnancy, run by Nova Southeastern University at 1 site in United States.
Trial summary
Stress-induced pregnancy complications are significant contributors to preterm labor as well as maternal and perinatal morbidity and mortality. The goals of this study are two folds: first it aims to capture the pregnant woman's journey to seek and receive prenatal care. Read more about this study
- Who is it for?
- Ages 21 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Simulated stimuli and Stress Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2024to 31 Dec 2026
- Phase
- Interventional
- 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 21 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- between 21 and 37 years of age
Who cannot join
- in less than 24 weeks gestation
- high risk pregnancies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nova Southeastern University
Davie, Florida, 33314
Gesulla Cavanaugh, PhD, MPH, MS, 954-262-1980, gcavanaugh@nova.edu
About this study
Official title: Mitigating Response to Stressors in the Pregnant Woman
Stress-induced pregnancy complications are significant contributors to preterm labor as well as maternal and perinatal morbidity and mortality. The goals of this study are two folds: first it aims to capture the pregnant woman's journey to seek and receive prenatal care. Second, this study aims to develop models that 1) assess the adverse health and biological effects of social factors on pregnant women who experience repeated or chronic stress, 2) address how stress can be mitigated in pregnant women from different backgrounds who experience high stress.
Read the detailed description
Maternal stress-induced complications are correlated with gestational hypertension, infant low birth weight, and developmental disruption. Various social determinants of health are contributors to stress in pregnant women; factors such as socioeconomic status, education, access to prenatal care, and neighborhood conditions are some of the most identified psychosocial causes of prenatal stress. Further, chronic psychosocial stress is identified as a significant contributor to biophysiological damages such as accelerated telomere shortening in the mother as well as the offspring. Using a public health approach, this research study proposes to gather evidence to assess how response to stress is modulated and how it is captured in and affects pregnant women, with history of prolonged exposure to harmful stressors. More relevant to this study, individuals who have repeated exposure to stressors have poorly managed response to stress and display frequent elevated heart rates due to biological and physiological disruptions. Evidence from the literature suggests that having a support system and utilizing stress management techniques moderate and buffer the effects of stress on physiological measures while facilitating emotional recovery.
- Conditions
- Pregnancy
- Being tested
- Simulated stimuli, Stress Management
- Keywords
- stressors, chronic stress, pregnancy, stress regulation, stress management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated stimuliBehavioural
Participants will be exposed to a video stimuli in order to assess biophysiological and physiological responses to the stressor and relaxant.
Stress ManagementBehavioural
Participants will practice stress management and stress reduction at home, independently.
| Study group | Role | What they receive |
|---|---|---|
| Stress Exposure and Management | Experimental | All pregnant participants will be exposed to a 50 second-mild stressful stimulus and a 50 second- relaxant to record physiological responses. The participants will then independently practice easy stress management techniques at home, such as breathing and listening to music. They will do so for one week after the initial data collection. Receives: Behavioral: Simulated stimuli; Behavioral: Stress Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress level change
change in stress measures as assessed by salivary cortisol levels from collected saliva before and after practicing stress management techniques. Cortisol levels are measured in ug/dL.
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start20 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gesulla Cavanaugh, PhD, MPH, MS, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718907
- Sponsor's protocol ID
- NSU 2023-231
- Status last verified
- Feb 2026
- First submitted
- 2 Dec 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Working with vulnerable populations and possible individuals from clinics located in underserved communities.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Response to Stressors in the Pregnant Woman
- ClinicalTrials.gov ID
- NCT06718907
- Acronym / sponsor ID
- NSU 2023-231
- Conditions
- Pregnancy
- Keywords
- stressors, chronic stress, pregnancy, stress regulation, stress management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Dec 2024 (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.
Stress-induced pregnancy complications are significant contributors to preterm labor as well as maternal and perinatal morbidity and mortality. The goals of this study are two folds: first it aims to capture the pregnant woman's journey to seek and receive prenatal care. Second, this study aims to develop models that 1) assess the adverse health and biological effects of social factors on pregnant women who experience repeated or chronic stress, 2) address how stress can be mitigated in pregnant women from different backgrounds who experience high stress.
Detailed description
Maternal stress-induced complications are correlated with gestational hypertension, infant low birth weight, and developmental disruption. Various social determinants of health are contributors to stress in pregnant women; factors such as socioeconomic status, education, access to prenatal care, and neighborhood conditions are some of the most identified psychosocial causes of prenatal stress. Further, chronic psychosocial stress is identified as a significant contributor to biophysiological damages such as accelerated telomere shortening in the mother as well as the offspring. Using a public health approach, this research study proposes to gather evidence to assess how response to stress is modulated and how it is captured in and affects pregnant women, with history of prolonged exposure to harmful stressors. More relevant to this study, individuals who have repeated exposure to stressors have poorly managed response to stress and display frequent elevated heart rates due to biological and physiological disruptions. Evidence from the literature suggests that having a support system and utilizing stress management techniques moderate and buffer the effects of stress on physiological measures while facilitating emotional recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress Exposure and Management | Experimental | Behavioral: Simulated stimuli, Behavioral: Stress ManagementAll pregnant participants will be exposed to a 50 second-mild stressful stimulus and a 50 second- relaxant to record physiological responses. The participants will then independently practice easy stress management techniques at home, such as breathing and listening to music. They will do so for one week after the initial data collection. |
Who may qualify
- Ages
- 21 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- between 21 and 37 years of age
Key exclusion criteria (2 listed)
- in less than 24 weeks gestation
- high risk pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulated stimuliParticipants will be exposed to a video stimuli in order to assess biophysiological and physiological responses to the stressor and relaxant. | Behavioural | Stress Exposure and Management |
| Stress ManagementParticipants will practice stress management and stress reduction at home, independently. | Behavioural | Stress Exposure and Management |
Primary outcome
Stress level change
Time frame: 4-8 weeks
change in stress measures as assessed by salivary cortisol levels from collected saliva before and after practicing stress management techniques. Cortisol levels are measured in ug/dL.
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 25 Feb 2026.
- Individual participant dataSharing planned: No. Working with vulnerable populations and possible individuals from clinics located in underserved communities.
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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.
Gesulla Cavanaugh, PhD, MPH, MS principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulated stimuli and Stress Management in people with Pregnancy, run by Nova Southeastern University at 1 site 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 1 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 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Gesulla Cavanaugh, PhD, MS, MPH (9542621980, gcavanaugh@nova.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress level change (time frame: 4-8 weeks). 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 25 Feb 2026.