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Completed

NCT Number: NCT01646463

Pilot Trial of CenteringPregnancy With Mindfulness Skills

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. preterm birth

    Time frame: post-birth

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

  2. birth weight

    Time frame: post-birth

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

  3. postpartum depression

    Time frame: post-birth

    incidence of self-reported postpartum depression

Secondary outcomes

  1. change in and level of perceived stress

    Time frame: second trimester, third trimester, post-birth

    self-report of perceived life stress

  2. 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

  3. change in and level of mindfulness

    Time frame: second trimester, third trimester, post-birth

    self-report of mindfulness of daily experiences

  4. 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

  5. change in and level of pregnancy-related anxiety

    Time frame: second trimester, third trimester

    self-report of pregnancy-related anxiety

  6. change in and level of depressive mood

    Time frame: second trimester, third trimester

    self-report of depressive mood

  7. change in and levels of salivary cortisol

    Time frame: second trimester, third trimester

    waking, 30-minutes post-waking, and bed-time salivary cortisol

  8. change in and level of adrenocorticotropic hormone (ACTH)

    Time frame: second trimester, third trimester

    adrenocorticotropic hormone (ACTH) assayed from blood plasma

  9. change in and levels of corticotropin releasing hormone (CRH)

    Time frame: second trimester, third trimester

    corticotropin releasing hormone (CRH) assayed from blood plasma

  10. change in and levels of blood pressure

    Time frame: second trimester, third trimester

    diastolic and systolic blood pressure

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Integrative Stress Reduction for Maternal-Child Health

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jul 20, 2012
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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