Pilot Trial of CenteringPregnancy With Mindfulness Skills

NCT01646463 | Completed DMC

• 1 other identifier: K01AT005270
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• preterm birth

  gestational age at birth and risk of preterm birth (\<37 weeks)

  post-birth

• birth weight

  birth weight in grams, birth weight to gestational age ratio, and risk of low birth weight (\<2500 grams)

  post-birth

• postpartum depression

  incidence of self-reported postpartum depression

  post-birth

Secondary Outcomes (10)

• change in and level of perceived stress

  second trimester, third trimester, post-birth

• change in and type(s) of coping

  second trimester, third trimester, post-birth

• change in and level of mindfulness

  second trimester, third trimester, post-birth

• change in and level of positive and negative emotion

  second trimester, third trimester, post-birth

• change in and level of pregnancy-related anxiety

  second trimester, third trimester

Study Arms (2)

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.

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.

Behavioral: CenteringPregnancy

Interventions

CenteringPregnancy BEHAVIORAL

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; CenteringPregnancy with Mindfulness Skills

CenteringPregnancy with Mindfulness Skills BEHAVIORAL

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.

CenteringPregnancy with Mindfulness Skills

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 and over
• enrolled to receive group-based prenatal healthcare from the San Francisco General Hospital (SFGH) Outpatient Midwifery Clinic CenteringPregnancy program

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Premature Birth; Depression, Postpartum; Depression; Birth Weight

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Larissa G Duncan, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: July 20, 2012
• Study Start: January 1, 2011
• Primary Completion: May 3, 2017
• Study Completion: May 3, 2017
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

US (1)