Clinical trial NCT01646463: Pilot Trial of CenteringPregnancy With Mindfulness Skills
Official title: Integrative Stress Reduction for Maternal-Child Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Low Birth Weight
Postpartum Depression
Keywords: mindfulness
stress
coping
emotion
depression
group medical visits
prenatal healthcare
preterm birth
birth weight
postpartum depression
cortisol
neuroendocrine function
blood pressure
health disparities
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* age 18 and over
* enrolled to receive group-based prenatal healthcare from the San Francisco General Hospital (SFGH) Outpatient Midwifery Clinic CenteringPregnancy program

Exclusion Criteria:

* ineligible for CenteringPregnancy due to the need for individualized prenatal care
* Type 2 diabetes
* HIV
* 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

Primary outcomes:
measure: preterm birth
timeFrame: post-birth
measure: birth weight
timeFrame: post-birth
measure: postpartum depression
timeFrame: post-birth
Secondary outcomes:
measure: change in and level of perceived stress
timeFrame: second trimester, third trimester, post-birth
measure: change in and type(s) of coping
timeFrame: second trimester, third trimester, post-birth
measure: change in and level of mindfulness
timeFrame: second trimester, third trimester, post-birth
measure: change in and level of positive and negative emotion
timeFrame: second trimester, third trimester, post-birth
measure: change in and level of pregnancy-related anxiety
timeFrame: second trimester, third trimester
measure: change in and level of depressive mood
timeFrame: second trimester, third trimester
measure: change in and levels of salivary cortisol
timeFrame: second trimester, third trimester
measure: change in and level of adrenocorticotropic hormone (ACTH)
timeFrame: second trimester, third trimester
measure: change in and levels of corticotropin releasing hormone (CRH)
timeFrame: second trimester, third trimester
measure: change in and levels of blood pressure
timeFrame: second trimester, third trimester
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Larissa G Duncan, PhD
role: PRINCIPAL_INVESTIGATOR
References: