Pilot Trial of CenteringPregnancy With Mindfulness Skills

Premature Birth Clinical Trial

Official title:

Integrative Stress Reduction for Maternal-Child Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01646463
• Other study ID #: K01AT005270
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: May 3, 2017

Study information

• Verified date: February 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 3, 2017
• Est. primary completion date: May 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Depression
• Depression, Postpartum
• Low Birth Weight
• Postpartum Depression
• Premature Birth

Intervention

Behavioral:
• CenteringPregnancy
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
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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

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