Stress, Coping and Health Behaviors in Pregnancy

NCT02705235 | Completed

• 1 other identifier: 0718-15-EP
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Stress is an important determinant of pregnancy health behaviors, maternal physiology and maternal-infant health outcomes. The purpose of this study is to explain the relationship between dimensions of lifetime stress and the stress hormone cortisol in pregnant women. Additionally, the study will examine how coping styles help pregnant women to better manage stress and improve their health behaviors to achieve the goal of having a healthy baby.

Conditions

Pregnancy; Stress; Coping; Health Behaviors

Outcome Measures

Primary Outcomes (4)

• Cortisol Awakening Response

  Participants will collect saliva samples at home by chewing a cotton swab for 1 to 2 minutes. Samples will be collected five times a day for three days. The swab is then placed in a labeled plastic container and stored the container in a home refrigerator. Once returned to the lab, the samples are processed for cortisol awakening response.

  26 weeks gestation

• Diurnal Slope

  Participants will collect saliva samples at home by chewing a cotton swab for 1 to 2 minutes. Samples will be collected five times a day for three days. The swab is then placed in a labeled plastic container and stored the container in a home refrigerator. Once returned to the lab, the samples are processed for diurnal slope.

  26 weeks gestation

• Area Under the Curve (AUC)-Increase

  Participants will collect saliva samples at home by chewing a cotton swab for 1 to 2 minutes. Samples will be collected five times a day for three days. The swab is then placed in a labeled plastic container and stored the container in a home refrigerator. Once returned to the lab, the samples are processed for index of the sensitivity of the cortisol response to a stressor (AUC-Increase).

  26 weeks gestation

• Area Under the Curve (AUC)-Ground

  Participants will collect saliva samples at home by chewing a cotton swab for 1 to 2 minutes. Samples will be collectd five times a day for three days. The swab is then placed in a labeled plastic container and stored the container in a home refrigerator. Once returned to the lab, the samples are processed for total systemic "output" throughout all salivary cortisol measures (AUC-Ground).

  26 weeks gestation

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women aged 19 to 45 years old.

You may qualify if:

• Single intrauterine pregnancy at least 20 weeks gestation
• Aged 19 to 45
• Ability to read and speak English
• Able to be reached by telephone or text most days of the week

You may not qualify if:

• Receiving or referred for care in the high-risk prenatal clinic
• Have any of the following pregnancy complications or medical issues existing prior to recruitment:
• Cervical or uterine abnormalities, renal, hepatic or cardiac disorders, insulin-dependent diabetes, preeclampsia, regular oral steroid use in the month prior to data collection, congenital fetal abnormalities, active placenta previa, blood group isoimmunization, or other disorders/medication use that could affect cortisol levels
• Regular night-shift work or reversed sleep schedule

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Nebraska Medicine

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Crystal Epstein, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2016
• First Posted: March 10, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

US (1)