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Pilot Trial of CenteringPregnancy With Mindfulness Skills

Primary Purpose

Premature Birth, Low Birth Weight, Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CenteringPregnancy
CenteringPregnancy with Mindfulness Skills
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Birth focused on measuring mindfulness, stress, coping, emotion, depression, group medical visits, prenatal healthcare, preterm birth, birth weight, postpartum depression, cortisol, neuroendocrine function, blood pressure, health disparities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CenteringPregnancy with Mindfulness Skills

CenteringPregnancy

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 18, 2012
Last Updated
February 13, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01646463
Brief Title
Pilot Trial of CenteringPregnancy With Mindfulness Skills
Official Title
Integrative Stress Reduction for Maternal-Child Health
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 3, 2017 (Actual)
Study Completion Date
May 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CenteringPregnancy with Mindfulness Skills
Arm Type
Experimental
Arm Description
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.
Arm Title
CenteringPregnancy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CenteringPregnancy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CenteringPregnancy with Mindfulness Skills
Intervention Description
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.
Primary Outcome Measure Information:
Title
preterm birth
Description
gestational age at birth and risk of preterm birth (<37 weeks)
Time Frame
post-birth
Title
birth weight
Description
birth weight in grams, birth weight to gestational age ratio, and risk of low birth weight (<2500 grams)
Time Frame
post-birth
Title
postpartum depression
Description
incidence of self-reported postpartum depression
Time Frame
post-birth
Secondary Outcome Measure Information:
Title
change in and level of perceived stress
Description
self-report of perceived life stress
Time Frame
second trimester, third trimester, post-birth
Title
change in and type(s) of coping
Description
self-report of coping with salient stressful aspects of pregnancy and parenting
Time Frame
second trimester, third trimester, post-birth
Title
change in and level of mindfulness
Description
self-report of mindfulness of daily experiences
Time Frame
second trimester, third trimester, post-birth
Title
change in and level of positive and negative emotion
Description
self-report of intensity and frequency of positive and negative affect
Time Frame
second trimester, third trimester, post-birth
Title
change in and level of pregnancy-related anxiety
Description
self-report of pregnancy-related anxiety
Time Frame
second trimester, third trimester
Title
change in and level of depressive mood
Description
self-report of depressive mood
Time Frame
second trimester, third trimester
Title
change in and levels of salivary cortisol
Description
waking, 30-minutes post-waking, and bed-time salivary cortisol
Time Frame
second trimester, third trimester
Title
change in and level of adrenocorticotropic hormone (ACTH)
Description
adrenocorticotropic hormone (ACTH) assayed from blood plasma
Time Frame
second trimester, third trimester
Title
change in and levels of corticotropin releasing hormone (CRH)
Description
corticotropin releasing hormone (CRH) assayed from blood plasma
Time Frame
second trimester, third trimester
Title
change in and levels of blood pressure
Description
diastolic and systolic blood pressure
Time Frame
second trimester, third trimester

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larissa G Duncan, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

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Pilot Trial of CenteringPregnancy With Mindfulness Skills

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