- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02705235
Stress, Coping and Health Behaviors in Pregnancy
Stress, Coping and Health Behaviors During Pregnancy
Study Overview
Status
Conditions
Detailed Description
Health behaviors are important modifiable factors for promoting maternal-infant health during pregnancy, and include behaviors such as diet, exercise, and avoidance of harmful substances. During pregnancy, women are often motivated to improve their lifestyle to achieve positive pregnancy outcomes; however, they may struggle to do so because certain behaviors such as excessive eating, smoking and drinking have become a means for coping with stress. Stress prior to and during pregnancy negatively impacts birth outcomes via complex behavioral and physiologic pathways. From a behavioral perspective, stress diminishes women's engagement in positive health behaviors during pregnancy. From a physiologic perspective, stress affects the regulation of cortisol, a hormone involved in fetal development and timing of delivery. Women use various coping styles to manage stress. It is unknown, however, whether certain coping styles attenuate the negative behavioral and physiologic effects of stress on birth outcomes. Therefore, the purpose of this descriptive, cross-sectional study is to examine the influence of coping styles on stress, physiologic cortisol regulation and health behaviors in a diverse sample of pregnant women (N=55) during 24-28 weeks gestation.
A quantitative design with a qualitative arm will be used to:
- explain the relationship between cortisol regulation and lifetime stress,
- determine whether coping styles (active vs. disengaged) moderate the effect of stress on cortisol, health behaviors, and birth outcomes, and
- describe women's qualitative experience of stress and coping and determine the extent to which the qualitative findings converge with the quantitative findings.
Data will be collected over three prenatal visits during the second half of pregnancy, and will include self-report questionnaires, multiple salivary cortisol sampling, medical record data, a structured stress interview and a semi-structured qualitative interview in a subset of participants (n=12). This study will use an interview-based stress assessment in tandem with physiologic (i.e. cortisol) stress measures in pregnancy. Additionally, the qualitative data will provide a contextual understanding of pregnant women's stress and coping experiences. The research findings will inform the future development and testing of a psychosocial, coping-based intervention to promote positive health behaviors in pregnancy and birth outcomes. Furthermore, this training will provide a solid scientific foundation for the applicant to develop a career as an independent nurse-scientist in maternal-infant health promotion research, under the guidance of an experienced interdisciplinary team of mentors with complementary expertise in stress, coping health behavior, and pregnancy related research. The proposal is consistent with the National Institute of Nursing Research's (NINR) mission to support research that promotes health and prevents disease across the lifespan, builds the scientific foundation for clinical practice, and invests in the training of the next generation of nurse-scientists.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68198
- Nebraska Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cortisol Awakening Response
Time Frame: 26 weeks gestation
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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
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Diurnal Slope
Time Frame: 26 weeks gestation
|
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
Time Frame: 26 weeks gestation
|
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
Time Frame: 26 weeks gestation
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Crystal Epstein, PhD, University of Nebraska
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0718-15-EP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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