Purpose: The investigators hypothesize that exposure to chronic environmental stress is a risk factor for adverse pregnancy outcomes related to preterm birth and preeclampsia among high-risk pregnant women. Additionally, the investigators hypothesize that women can be screened for high levels of environmental stress through the perceived stress scale, and therapeutic writing can be used as a low-resource intervention to help decrease maternal perceived stress and inflammation - measured through analysis of maternal serum and placental samples. Participants: Pregnant women at high risk for adverse pregnancy outcomes, including pre-eclampsia and preterm birth, enrolled in prenatal care at UNC will be recruited for participation Procedures: Using results from the perceived stress scale, the investigators will identify women who screen positive for high environmental stress. Women meeting inclusion criteria will be contacted for possible participation at regularly scheduled prenatal visits. Women who are enrolled will be randomized to generalized writing prompts, therapeutic writing prompts, or no writing during their pregnancy to be administered at each prenatal visit. Maternal blood sample for biochemical markers of stress and gene expression will be obtained at the initial visit; a followup blood sample will be obtained later in pregnancy, and a small portion of the placenta saved at delivery. Delivery outcomes will be obtained through medical record review.
During pregnancy, women regularly interact with healthcare professionals, an often untapped resource and opportune time to optimize mental health, positively impacting outcomes. Cumulative psychosocial stress is a risk factor for several adverse obstetric outcomes including preterm birth (PTB), preeclampsia, fetal growth restriction, and postpartum depression. The overarching hypothesis of this study is that pregnant women with high levels of stress can be identified through easily-implemented screening tools; importantly, the investigators propose that these women can be engaged in care via a cost-effective therapeutic writing intervention combined with the availability of expert pastoral and perinatal psychiatry resources. Women will be enrolled early in pregnancy and followed prospectively. Some women (if randomized to a writing group) will complete a standardized writing prompt at several time points during gestation. The investigators will follow their outcomes prospectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
15
Participants will be given journals with writing prompts to be completed throughout their pregnancy.
University of North Carolina Women's Hospital
Chapel Hill, North Carolina, United States
Percent Participation in Writing Activity
The percentage of women who respond that they completed their assigned writing activity will be measured.
Time frame: through study completion, an average of 7 months per participant and 2 years for entire study
Statistically significant improvement (reduction) in the Perceived Stress Scale Score
Psychological instrument used to measure one's perception of stress (score range 0-40) will be assessed before and after the assigned writing activity. Higher scores on the scale indicate a higher vulnerability for those with a high levels of perceived stress in their life. Prior studies have noted the average score for a female age 30-44 is approximately 14.
Time frame: through study completion, an average of 7 months per participant and 2 years for entire study
Proportion of women with adverse perinatal outcomes
We will define adverse pregnancy outcomes as a composite of preterm birth \<37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups
Time frame: outcome will be ascertained at delivery
Change in pro-inflammatory biomarkers in maternal blood by randomization group
All women participating in the study will have a blood draw. Levels of stress biomarkers (e.g., interleukin-6) will be compared by randomization group
Time frame: through study completion, an average of 7 months per participant and 2 years for entire study
Change in pro-inflammatory biomarkers in maternal blood by outcome
All women participating in the study will have a blood draw. Levels of stress biomarkers (e.g., interleukin-6) will be compared between women who develop the adverse perinatal outcome and those who do not
Time frame: through study completion, an average of 7 months per participant and 2 years for entire study
Change in stress-related gene expression in maternal blood by randomization group
All women participating in the study will have a blood draw. We will evaluate gene expression of the CTRA gene panel (conserved transcriptional response to adversity gene panel) by randomization group
Time frame: through study completion, an average of 7 months per participant and 2 years for entire study
Change in stress-related gene expression in maternal blood by outcome
All women participating in the study will have a blood draw. We will evaluate gene expression of the CTRA gene panel (conserved transcriptional response to adversity gene panel) by whether or not the patient developed the adverse perinatal outcome
Time frame: through study completion, an average of 7 months per participant and 2 years for entire study
Utilization of professional psychiatric care
proportion of women who initiate or continue therapy with professional psychiatric care provider
Time frame: through study completion, an average of 7 months per participant and 2 years for entire study
Stress related pathways gene expression - placental tissue - by randomization group
After delivery, we will evaluate whether there are differences in the conserved transcriptional response to adversity gene panel (CTRA gene panel) by randomization groups
Time frame: through study completion, an average of 7 months per participant and 2 years for entire study
Stress related pathways gene expression - placental tissue - by diagnosis of adverse perinatal outcome
After delivery, we will evaluate whether there are differences in the conserved transcriptional response to adversity gene panel (CTRA gene panel) by whether or not the patient developed the adverse perinatal outcome
Time frame: through study completion, an average of 7 months per participant and 2 years for entire study
Rate of preterm birth less than 37 weeks' gestation by randomization group
we will individually evaluate the outcomes of preterm birth \<37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups
Time frame: through study completion, an average of 7 months per participant and 2 years for entire study
Rate of diagnosis of intrauterine growth restriction, using sex-specific curves, by randomization group
we will individually evaluate the outcomes of preterm birth \<37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups
Time frame: through study completion, an average of 7 months per participant and 2 years for entire study
Rate of diagnosis of preeclampsia by randomization group
we will individually evaluate the outcomes of preterm birth \<37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups
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Time frame: through study completion, an average of 7 months per participant and 2 years for entire study
Rate of diagnosis of placental abruption by randomization group
we will individually evaluate the outcomes of preterm birth \<37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups
Time frame: through study completion, an average of 7 months per participant and 2 years for entire study