- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01646463
Pilot Trial of CenteringPregnancy With Mindfulness Skills
February 13, 2020 updated by: University of California, San Francisco
Integrative Stress Reduction for Maternal-Child Health
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94115
- University of California, San Francisco
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 (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.
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
preterm birth
Time Frame: post-birth
|
gestational age at birth and risk of preterm birth (<37 weeks)
|
post-birth
|
birth weight
Time Frame: post-birth
|
birth weight in grams, birth weight to gestational age ratio, and risk of low birth weight (<2500 grams)
|
post-birth
|
postpartum depression
Time Frame: post-birth
|
incidence of self-reported postpartum depression
|
post-birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in and level of perceived stress
Time Frame: second trimester, third trimester, post-birth
|
self-report of perceived life stress
|
second trimester, third trimester, post-birth
|
change in and type(s) of coping
Time Frame: second trimester, third trimester, post-birth
|
self-report of coping with salient stressful aspects of pregnancy and parenting
|
second trimester, third trimester, post-birth
|
change in and level of mindfulness
Time Frame: second trimester, third trimester, post-birth
|
self-report of mindfulness of daily experiences
|
second trimester, third trimester, post-birth
|
change in and level of positive and negative emotion
Time Frame: second trimester, third trimester, post-birth
|
self-report of intensity and frequency of positive and negative affect
|
second trimester, third trimester, post-birth
|
change in and level of pregnancy-related anxiety
Time Frame: second trimester, third trimester
|
self-report of pregnancy-related anxiety
|
second trimester, third trimester
|
change in and level of depressive mood
Time Frame: second trimester, third trimester
|
self-report of depressive mood
|
second trimester, third trimester
|
change in and levels of salivary cortisol
Time Frame: second trimester, third trimester
|
waking, 30-minutes post-waking, and bed-time salivary cortisol
|
second trimester, third trimester
|
change in and level of adrenocorticotropic hormone (ACTH)
Time Frame: second trimester, third trimester
|
adrenocorticotropic hormone (ACTH) assayed from blood plasma
|
second trimester, third trimester
|
change in and levels of corticotropin releasing hormone (CRH)
Time Frame: second trimester, third trimester
|
corticotropin releasing hormone (CRH) assayed from blood plasma
|
second trimester, third trimester
|
change in and levels of blood pressure
Time Frame: second trimester, third trimester
|
diastolic and systolic blood pressure
|
second trimester, third trimester
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Larissa G Duncan, PhD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
May 3, 2017
Study Completion (Actual)
May 3, 2017
Study Registration Dates
First Submitted
July 18, 2012
First Submitted That Met QC Criteria
July 18, 2012
First Posted (Estimate)
July 20, 2012
Study Record Updates
Last Update Posted (Actual)
February 17, 2020
Last Update Submitted That Met QC Criteria
February 13, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K01AT005270 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Premature Birth
-
Shaare Zedek Medical CenterTerminatedPremature Birth of NewbornIsrael
-
University of VirginiaCompletedPremature Birth of NewbornUnited States
-
Case Western Reserve UniversityCompleted
-
University of California, San FranciscoUniversity of California, San Diego; University of California, Los Angeles; Kaiser...CompletedPremature Birth of NewbornUnited States
-
Universitaire Ziekenhuizen KU LeuvenKU LeuvenUnknownPremature Birth of NewbornBelgium
-
Universidad Complutense de MadridCompletedPremature Birth of Newborn
-
Indiana UniversityCompletedPremature LaborUnited States
-
Washington University School of MedicineUniversity of Southern CaliforniaCompletedPremature Birth of NewbornUnited States
-
University of ArkansasCompletedPremature Birth of NewbornUnited States
-
Elgan Pharma Ltd.Terminated
Clinical Trials on CenteringPregnancy
-
NorthShore University HealthSystemUniversity of California, Los Angeles; Northwestern University; Prisma Health-UpstateCompletedPreterm BirthUnited States
-
Clemson UniversityUniversity of California, Los Angeles; Prisma Health-Upstate; Georgia State UniversityCompleted
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedHIV Infections | Sexually Transmitted Diseases | PregnancyUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedHIV Infections | Sexually Transmitted DiseasesUnited States