Writing to Reduce Stress in Expectant Moms: The RESet Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Percent Participation in Writing Activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants will have identical journals regardless of the intervention or control group status, and providers will be blinded to the writing prompts that participants are given. Women who are randomized to 'no writing' will be provided a blank journal without any instruction. this will be considered a 'gift' for study participation
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women will be prospectively recruited.
- •Gestational age: All women presenting for prenatal care at 8.0 to 19.9 weeks' gestation through the UNC-Hospitals High Risk obstetrics clinic will be screened for high risk of an adverse pregnancy outcome (ex: preterm birth or pre-eclampsia) through review of their medical record.
- •Singleton viable intrauterine pregnancy, with dating confirmed by ultrasound or plans for ultrasound to confirm dating prior to study enrollment
- •No structural abnormalities or aneuploidy
- •Ability to communicate in and provide consent in English
- •Women with at least ONE of the following high risk criteria:
- •a. Short cervix by endovaginal ultrasound, measuring <25mm b. Prior spontaneous preterm birth 16.0 - 33.9 weeks' gestation i. Documentation of the prior spontaneous preterm birth in the patient's medical records is desirable but is not required for eligibility.
- •ii. The previous preterm delivery cannot be an antepartum stillbirth but an intrapartum stillbirth (due to extreme prematurity) is allowable.
- •c. Chronic hypertension on medications d. History of pre-eclampsia requiring delivery <37 weeks' gestation, or history of severe pre-eclampsia delivering at any gestational age
- •Women with at least TWO of the following moderate risk criteria:
- •Prior preterm birth 34.0-36.9 weeks
- •Chronic hypertension not requiring medications
- •History of term pre-eclampsia
- •Type II diabetes on insulin
- •Obesity with a BMI >30
- •Smoking during pregnancy
- •Maternal age <18 years old or >40 years old
- •Nulliparous
- •Uninsured, or medicaid insurance
- •Women who meet at least one major or 2 minor inclusion criteria along with the other criteria above will then be screened for high levels of acute and chronic stress and trauma using the Perceived Stress questionnaire to determine final eligibility for the study
排除标准
- •Persistent Illicit drug or alcohol abuse during current pregnancy >12 weeks. Use of tobacco and/or marijuana is not an exclusion. Methadone or suboxone use in an approved treatment program is not an exclusion.
- •Prior preterm birth or preeclampsia was in a pregnancy complicated by fetal aneuploidy or major congenital fetal anomalies in the absence of another pregnancy meeting above inclusion criteria
- •Major congenital anomaly such as major structural deficit of the heart, lungs, or brain or aneuploidy
- •Mild renal abnormalities, clubfoot, isolated cleft lip/palate, etc. in the fetus are not a reason for exclusion
- •For a detailed list of major anomalies, see Table 3 - Major Fetal Anomalies / Congenital Malformations, below. Two or more minor anomalies observed together (see Table 2 - Minor Fetal Anomalies / Congenital Malformations) count as a "major" anomaly
- •Isolated 'soft markers' for aneuploidy (such as choroid plexus cysts, echogenic bowel, etc.) are not a reason for exclusion
- •If aneuploidy screening is performed, any aneuploidy screen positive test with a risk for aneuploidy greater than 1 in 25 without negative confirmatory definitive aneuploidy testing is reason for exclusion
- •Spanish speaking women
- •Women participating in other intervention-based studies
结局指标
主要结局
Percent Participation in Writing Activity
时间窗: through study completion, an average of 7 months per participant and 2 years for entire study
The percentage of women who respond that they completed their assigned writing activity will be measured.
Statistically significant improvement (reduction) in the Perceived Stress Scale Score
时间窗: through study completion, an average of 7 months per participant and 2 years for entire study
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.
Change in stress-related gene expression in maternal blood by randomization group
时间窗: through study completion, an average of 7 months per participant and 2 years for entire study
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
Change in pro-inflammatory biomarkers in maternal blood by outcome
时间窗: through study completion, an average of 7 months per participant and 2 years for entire study
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
Proportion of women with adverse perinatal outcomes
时间窗: outcome will be ascertained at delivery
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
Change in pro-inflammatory biomarkers in maternal blood by randomization group
时间窗: through study completion, an average of 7 months per participant and 2 years for entire study
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
Change in stress-related gene expression in maternal blood by outcome
时间窗: through study completion, an average of 7 months per participant and 2 years for entire study
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
次要结局
- Rate of diagnosis of placental abruption by randomization group(through study completion, an average of 7 months per participant and 2 years for entire study)
- Rate of diagnosis of preeclampsia by randomization group(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(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(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(through study completion, an average of 7 months per participant and 2 years for entire study)
- Utilization of professional psychiatric care(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(through study completion, an average of 7 months per participant and 2 years for entire study)