Overview

This trial is active, not recruiting.

Conditions premature birth, low birth weight, postpartum depression
Treatments centeringpregnancy, centeringpregnancy with mindfulness skills
Phase phase 1/phase 2
Sponsor University of California, San Francisco
Start date January 2011
End date February 2015
Trial size 49 participants
Trial identifier NCT01646463, K01AT005270

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
Arm
(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.
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.
(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.
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.

Primary Outcomes

Measure
preterm birth
time frame: post-birth
birth weight
time frame: post-birth
postpartum depression
time frame: post-birth

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Integrative Stress Reduction for Maternal-Child Health
Principal investigator Larissa G Duncan, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of California, San Francisco.