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NCT Number: NCT02705235

Stress, Coping and Health Behaviors in 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.

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Key information

Age range

19 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Nebraska Medicine

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

Stress, Coping and Health Behaviors During Pregnancy

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 10, 2016
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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