Mitigating Response to Stressors in Pregnant Women

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Behavioral: Simulated stimuli; Behavioral: Stress Management

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gesulla Cavanaugh, PhD, MS, MPH; Phone Number: 9542621980; Email: gcavanaugh@nova.edu

Study Locations

• United States
  • Florida
    • Davie, Florida, United States, 33314
      • Recruiting
      • Nova Southeastern University
      • Contact: Gesulla Cavanaugh, PhD, MPH, MS; Phone Number: 954-262-1980; Email: gcavanaugh@nova.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stress Exposure and Management; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4-8 weeks

Collaborators and Investigators

• Sponsor: Nova Southeastern University
• Investigators: Principal Investigator: Gesulla Cavanaugh, PhD, MPH, MS, Nova Southeastern University

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: stressors, chronic stress, pregnancy, stress regulation, stress management
• Other Study ID Numbers: NSU 2023-231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Working with vulnerable populations and possible individuals from clinics located in underserved communities.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No