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Recruiting NCT06718907

Mitigating Response to Stressors in Pregnant Women

No phase Interventional Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Simulated stimuli, Stress Management.
Who it may be relevant to
Registry conditions: Pregnancy. Basic parameters: 21 years — 37 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Mitigating Response to Stressors in the Pregnant Woman

Overview

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

  • Behavioral Simulated stimuli
    Participants will be exposed to a video stimuli in order to assess biophysiological and physiological responses to the stressor and relaxant.
  • Behavioral Stress Management
    Participants will practice stress management and stress reduction at home, independently.

Primary outcome measures

  • Stress level change [Time frame: 4-8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Nova Southeastern University — Davie

Identifiers

NCT: NCT06718907 · NSU 2023-231

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗