Premature BirthNCT01646463
Pilot Trial of CenteringPregnancy With Mindfulness Skills
A study testing CenteringPregnancy and CenteringPregnancy with Mindfulness Skills in people with Premature Birth and Low Birth Weight, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Low Birth Weight, Postpartum Depression
- What is being tested?
- CenteringPregnancy and CenteringPregnancy with Mindfulness Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to 3 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 and over
- enrolled to receive group-based prenatal healthcare from the San Francisco General Hospital (SFGH) Outpatient Midwifery Clinic CenteringPregnancy program
Who cannot join
- 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
Show all 9Show fewer
- not fluent in English or Spanish
- previous formal training in meditation, yoga, or other mind-body practice
- previous participation in CenteringPregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94115
About this study
Official title: 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.
- Conditions
- Premature Birth, Low Birth Weight, Postpartum Depression
- Being tested
- CenteringPregnancy, CenteringPregnancy with Mindfulness Skills
- Keywords
- mindfulness, stress, coping, emotion, depression, group medical visits, prenatal healthcare, preterm birth, birth weight, postpartum depression, cortisol, neuroendocrine function, blood pressure, health disparities
- Medical subject headings
- Premature Birth, Depression, Postpartum, Depression, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenteringPregnancyBehavioural
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 SkillsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CenteringPregnancy with Mindfulness Skills | Experimental | 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. Receives: Behavioral: CenteringPregnancy; Behavioral: CenteringPregnancy with Mindfulness Skills |
| CenteringPregnancy | Active comparator | 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. Receives: Behavioral: CenteringPregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
preterm birth
gestational age at birth and risk of preterm birth (<37 weeks)
Measured: post-birth
birth weight
birth weight in grams, birth weight to gestational age ratio, and risk of low birth weight (<2500 grams)
Measured: post-birth
postpartum depression
incidence of self-reported postpartum depression
Measured: post-birth
Secondary outcomes (10)
change in and level of perceived stress
self-report of perceived life stress
Measured: second trimester, third trimester, post-birth
change in and type(s) of coping
self-report of coping with salient stressful aspects of pregnancy and parenting
Measured: second trimester, third trimester, post-birth
change in and level of mindfulness
self-report of mindfulness of daily experiences
Measured: second trimester, third trimester, post-birth
change in and level of positive and negative emotion
self-report of intensity and frequency of positive and negative affect
Measured: second trimester, third trimester, post-birth
change in and level of pregnancy-related anxiety
self-report of pregnancy-related anxiety
Measured: second trimester, third trimester
change in and level of depressive mood
self-report of depressive mood
Measured: second trimester, third trimester
change in and levels of salivary cortisol
waking, 30-minutes post-waking, and bed-time salivary cortisol
Measured: second trimester, third trimester
change in and level of adrenocorticotropic hormone (ACTH)
adrenocorticotropic hormone (ACTH) assayed from blood plasma
Measured: second trimester, third trimester
change in and levels of corticotropin releasing hormone (CRH)
corticotropin releasing hormone (CRH) assayed from blood plasma
Measured: second trimester, third trimester
change in and levels of blood pressure
diastolic and systolic blood pressure
Measured: second trimester, third trimester
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJan 2011
- Primary completion3 May 2017
- Study completion3 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Larissa G Duncan, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646463
- Sponsor's protocol ID
- K01AT005270
- Status last verified
- Feb 2020
- First submitted
- 18 Jul 2012
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Stress Reduction for Maternal-Child Health
- ClinicalTrials.gov ID
- NCT01646463
- Acronym / sponsor ID
- K01AT005270
- Conditions
- Premature Birth, Low Birth Weight, Postpartum Depression
- Keywords
- mindfulness, stress, coping, emotion, depression, group medical visits, prenatal healthcare, preterm birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 3 May 2017 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CenteringPregnancy with Mindfulness Skills | Experimental | Behavioral: CenteringPregnancy, Behavioral: CenteringPregnancy with Mindfulness SkillsCenteringPregnancy 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 | Active comparator | Behavioral: CenteringPregnancyCenteringPregnancy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 and over
- enrolled to receive group-based prenatal healthcare from the San Francisco General Hospital (SFGH) Outpatient Midwifery Clinic CenteringPregnancy program
Key exclusion criteria (9 listed)
- ineligible for CenteringPregnancy due to the need for individualized prenatal care
- Type 2 diabetes
- HIV
- seizure disorder
- serious mental health disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CenteringPregnancyCenteringPregnancy (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. | Behavioural | CenteringPregnancy, CenteringPregnancy with Mindfulness Skills |
| CenteringPregnancy with Mindfulness SkillsCenteringPregnancy 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. | Behavioural | CenteringPregnancy with Mindfulness Skills |
Primary outcome
preterm birth
Time frame: post-birth
gestational age at birth and risk of preterm birth (<37 weeks)
birth weight
Time frame: post-birth
birth weight in grams, birth weight to gestational age ratio, and risk of low birth weight (<2500 grams)
postpartum depression
Time frame: post-birth
incidence of self-reported postpartum depression
10 secondary outcomes
change in and level of perceived stress
Time frame: second trimester, third trimester, post-birth
change in and type(s) of coping
Time frame: second trimester, third trimester, post-birth
change in and level of mindfulness
Time frame: second trimester, third trimester, post-birth
change in and level of positive and negative emotion
Time frame: second trimester, third trimester, post-birth
change in and level of pregnancy-related anxiety
Time frame: second trimester, third trimester
change in and level of depressive mood
Time frame: second trimester, third trimester
change in and levels of salivary cortisol
Time frame: second trimester, third trimester
change in and level of adrenocorticotropic hormone (ACTH)
Time frame: second trimester, third trimester
change in and levels of corticotropin releasing hormone (CRH)
Time frame: second trimester, third trimester
change in and levels of blood pressure
Time frame: second trimester, third trimester
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larissa G Duncan, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CenteringPregnancy and CenteringPregnancy with Mindfulness Skills in people with Premature Birth and Low Birth Weight, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preterm birth (time frame: post-birth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.