Integrative Stress Reduction for Maternal-Child Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- preterm birth
研究概览
简要总结
In the U.S., rates of preterm birth and low birth weight have increased over the past 30 years. Poor birth outcomes are especially high among racial/ethnic minority populations. Maternal stress is an important factor that can lead to negative birth outcomes. Thus, programs that reduce stress during pregnancy could improve birth outcomes. Initial pilot work tested a mindfulness-based approach to stress reduction during pregnancy. Women in the pilot study had lower stress and improved coping after the program. For the current study, mindfulness is added to an existing prenatal healthcare program called CenteringPregnancy (CP). CP provides prenatal care through 10 group sessions. This study compares CP with a version of CP infused with mindfulness skills training. Effects of the two versions of CP on psychological stress and coping, stress hormones, and birth outcomes will be tested. Data will be collected from participants three times: twice during pregnancy and once after birth. Medical records will provide data on birth outcomes and other health factors. The study will provide initial information about a mind-body program to reduce stress and improve birth outcomes. Data from the study will inform the development of an R01 proposal for a larger study. The study will also help advance the long term goal of reducing health disparities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 18 and over
- •enrolled to receive group-based prenatal healthcare from the San Francisco General Hospital (SFGH) Outpatient Midwifery Clinic CenteringPregnancy program
排除标准
- •ineligible for CenteringPregnancy due to the need for individualized prenatal care
- •Type 2 diabetes
- •seizure disorder
- •serious mental health disorder
- •substance abuse or medical condition that would lead to inability to adhere to intervention guidelines
- •not fluent in English or Spanish
- •previous formal training in meditation, yoga, or other mind-body practice
- •previous participation in CenteringPregnancy
结局指标
主要结局
preterm birth
时间窗: post-birth
gestational age at birth and risk of preterm birth (\<37 weeks)
birth weight
时间窗: post-birth
birth weight in grams, birth weight to gestational age ratio, and risk of low birth weight (\<2500 grams)
postpartum depression
时间窗: post-birth
incidence of self-reported postpartum depression
次要结局
- change in and level of perceived stress(second trimester, third trimester, post-birth)
- change in and type(s) of coping(second trimester, third trimester, post-birth)
- change in and level of mindfulness(second trimester, third trimester, post-birth)
- change in and level of positive and negative emotion(second trimester, third trimester, post-birth)
- change in and level of pregnancy-related anxiety(second trimester, third trimester)
- change in and level of depressive mood(second trimester, third trimester)
- change in and levels of salivary cortisol(second trimester, third trimester)
- change in and level of adrenocorticotropic hormone (ACTH)(second trimester, third trimester)
- change in and levels of corticotropin releasing hormone (CRH)(second trimester, third trimester)
- change in and levels of blood pressure(second trimester, third trimester)