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Mitigating Response to Stressors in Pregnant Women

Mitigating Response to Stressors in the Pregnant Woman

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06718907
Enrollment
50
Registered
2024-12-05
Start date
2024-12-20
Completion date
2026-12-31
Last updated
2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

stressors, chronic stress, pregnancy, stress regulation, stress management

Brief 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. 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.

Interventions

BEHAVIORALSimulated stimuli

Participants will be exposed to a video stimuli in order to assess biophysiological and physiological responses to the stressor and relaxant.

BEHAVIORALStress Management

Participants will practice stress management and stress reduction at home, independently.

Sponsors

Nova Southeastern University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 37 Years
Healthy volunteers
Yes

Inclusion criteria

in 24 weeks gestation or more * between 21 and 37 years of age

Exclusion criteria

* in less than 24 weeks gestation * high risk pregnancies

Design outcomes

Primary

MeasureTime frameDescription
Stress level change4-8 weekschange 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.

Countries

United States

Contacts

CONTACTGesulla Cavanaugh, PhD, MS, MPH
gcavanaugh@nova.edu9542621980
PRINCIPAL_INVESTIGATORGesulla Cavanaugh, PhD, MPH, MS

Nova Southeastern University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026