University of California, San Francisco
San Francisco, California, 94115, United States
NCT Number: NCT01646463
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
San Francisco, California, 94115, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CenteringPregnancy (CP) follows a standardized curriculum for group-based prenatal healthcare offered to groups of 10-12 women with similar due dates. In lieu of receiving a series of individually-delivered prenatal healthcare, participants meet 10 times over the course of pregnancy and early postpartum for 2 hour sessions, essentially pooling their minutes for each prenatal healthcare visit. The visit schedule adheres to the guidelines set forth by ACOG of monthly and then weekly visits close to birth. All sessions of CP include three core components of: (1) physical assessment (including blood pressure, weight, and fundal height assessment), (2) education and skills-building, and (3) support. Content topics for group discussion include nutrition, exercise, relaxation, understanding pregnancy problems, infant care and feeding, postpartum issues including contraception, comfort measures in pregnancy, sexuality and childbearing, abuse issues, parenting, and childbirth preparation.
CenteringPregnancy with Mindfulness Skills contains the CenteringPregnancy (CP) content combined with training in mindfulness meditation and mindful movement/yoga. The mind-body methods have been adapted from those taught in the Mindfulness-Based Childbirth and Parenting (MBCP) course, which is a tailored version of the Mindfulness-Based Stress Reduction program delivered to pregnant women during the perinatal period. These practices include mindfulness meditation of the breath, body, feelings, thoughts, and emotions; body scan meditation; yoga postures practiced with mindful awareness of the body and the physical changes associated with pregnancy; and loving-kindness meditation. In addition, MBCP includes specific exercises in coping with stress, pain, and fear associated with pregnancy, childbirth, and early parenting with a focus on shifting the way participants relate to negative thoughts and emotions and cope with stress.
Time frame: post-birth
gestational age at birth and risk of preterm birth (<37 weeks)
Time frame: post-birth
birth weight in grams, birth weight to gestational age ratio, and risk of low birth weight (<2500 grams)
Time frame: post-birth
incidence of self-reported postpartum depression
Time frame: second trimester, third trimester, post-birth
self-report of perceived life stress
Time frame: second trimester, third trimester, post-birth
self-report of coping with salient stressful aspects of pregnancy and parenting
Time frame: second trimester, third trimester, post-birth
self-report of mindfulness of daily experiences
Time frame: second trimester, third trimester, post-birth
self-report of intensity and frequency of positive and negative affect
Time frame: second trimester, third trimester
self-report of pregnancy-related anxiety
Time frame: second trimester, third trimester
self-report of depressive mood
Time frame: second trimester, third trimester
waking, 30-minutes post-waking, and bed-time salivary cortisol
Time frame: second trimester, third trimester
adrenocorticotropic hormone (ACTH) assayed from blood plasma
Time frame: second trimester, third trimester
corticotropin releasing hormone (CRH) assayed from blood plasma
Time frame: second trimester, third trimester
diastolic and systolic blood pressure
University of California, San Francisco
Other
Integrative Stress Reduction for Maternal-Child Health
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