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NCT Number: NCT06718907

Mitigating Response to Stressors in Pregnant Women

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.

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Key information

Conditions

Age range

21 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nova Southeastern University

Davie, Florida, 33314, United States

Location status: Recruiting

Location contact

Gesulla Cavanaugh, PhD, MPH, MS

CONTACT

[email protected]

954-262-1980

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simulated stimuli

Behavioral

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

Stress Management

Behavioral

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gesulla Cavanaugh, PhD, MS, MPH

CONTACT

[email protected]

9542621980

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Registry information

Official study title

Mitigating Response to Stressors in the Pregnant Woman

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2024
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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