Mitigating Response to Stressors in Pregnant Women

NCT06718907 | Recruiting

• 1 other identifier: NSU 2023-231
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Behavioral: Simulated stimuli; Behavioral: Stress Management

Interventions

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 Exposure and Management

Stress Management BEHAVIORAL

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

Stress Exposure and Management

Eligibility Criteria

• Age: 21 Years - 37 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• between 21 and 37 years of age

You may not qualify if:

• in less than 24 weeks gestation
• high risk pregnancies

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

Nova Southeastern University

Davie, Florida, 33314, United States

RECRUITING

Study Officials

• Gesulla Cavanaugh, PhD, MPH, MS

  Nova Southeastern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gesulla Cavanaugh, PhD, MS, MPH

CONTACT

9542621980; gcavanaugh@nova.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)