Pilot Trial of CenteringPregnancy With Mindfulness Skills

Not Applicable

Completed

• Conditions: Low Birth Weight; Premature Birth; Postpartum Depression
• Interventions: Behavioral: CenteringPregnancy; Behavioral: CenteringPregnancy with Mindfulness Skills

• Registration Number: NCT01646463
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-07-18
• Study First Submitted QC: 2012-07-18
• Study First Posted: 2012-07-20
• Primary Completion: 2017-05-03
• Study Completion: 2017-05-03
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CenteringPregnancy with Mindfulness Skills	CenteringPregnancy	CenteringPregnancy with Mindfulness Skills is the standard CenteringPregnancy prenatal healthcare intervention combined with mindfulness meditation and mindful movement/yoga applied to pregnancy, childbirth, and parenting.
CenteringPregnancy with Mindfulness Skills	CenteringPregnancy with Mindfulness Skills	CenteringPregnancy with Mindfulness Skills is the standard CenteringPregnancy prenatal healthcare intervention combined with mindfulness meditation and mindful movement/yoga applied to pregnancy, childbirth, and parenting.
CenteringPregnancy	CenteringPregnancy	CenteringPregnancy is group-based prenatal healthcare delivered according to the guidelines of the American College of Obstetrics and Gynecology. It includes assessment, support, and health education delivered in a healthcare empowerment framework.

Primary Outcome Measures

Name	Time	Method
preterm birth	post-birth	gestational age at birth and risk of preterm birth (\<37 weeks)
birth weight	post-birth	birth weight in grams, birth weight to gestational age ratio, and risk of low birth weight (\<2500 grams)
postpartum depression	post-birth	incidence of self-reported postpartum depression

Secondary Outcome Measures

Name	Time	Method
change in and level of perceived stress	second trimester, third trimester, post-birth	self-report of perceived life stress
change in and type(s) of coping	second trimester, third trimester, post-birth	self-report of coping with salient stressful aspects of pregnancy and parenting
change in and level of mindfulness	second trimester, third trimester, post-birth	self-report of mindfulness of daily experiences
change in and level of positive and negative emotion	second trimester, third trimester, post-birth	self-report of intensity and frequency of positive and negative affect
change in and level of pregnancy-related anxiety	second trimester, third trimester	self-report of pregnancy-related anxiety
change in and level of depressive mood	second trimester, third trimester	self-report of depressive mood
change in and levels of salivary cortisol	second trimester, third trimester	waking, 30-minutes post-waking, and bed-time salivary cortisol
change in and level of adrenocorticotropic hormone (ACTH)	second trimester, third trimester	adrenocorticotropic hormone (ACTH) assayed from blood plasma
change in and levels of corticotropin releasing hormone (CRH)	second trimester, third trimester	corticotropin releasing hormone (CRH) assayed from blood plasma
change in and levels of blood pressure	second trimester, third trimester	diastolic and systolic blood pressure

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States