PregnancyNCT02705235
Stress, Coping and Health Behaviors in Pregnancy
An observational study of Pregnancy and Stress, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women aged 19 to 45 years old.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stress, Coping and Health Behaviors During Pregnancy
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.
Read the 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.
- Conditions
- Pregnancy, Stress, Coping, Health Behaviors
- Medical subject headings
- Health Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 26 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Crystal Epstein, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705235
- Sponsor's protocol ID
- 0718-15-EP
- Status last verified
- Nov 2023
- First submitted
- 5 Mar 2016
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress, Coping and Health Behaviors During Pregnancy
- ClinicalTrials.gov ID
- NCT02705235
- Acronym / sponsor ID
- 0718-15-EP
- Conditions
- Pregnancy, Stress, Coping, Health Behaviors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women aged 19 to 45 years old.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cortisol Awakening Response
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 cortisol awakening response.
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.
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Crystal Epstein, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Stress, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortisol Awakening Response (time frame: 26 weeks gestation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.