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Pilot Trial of CenteringPregnancy With Mindfulness Skills

13. februar 2020 opdateret af: University of California, San Francisco

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

49

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94115
        • University of California, San Francisco

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CenteringPregnancy with Mindfulness Skills
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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.
Aktiv komparator: CenteringPregnancy
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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
preterm birth
Tidsramme: post-birth
gestational age at birth and risk of preterm birth (<37 weeks)
post-birth
birth weight
Tidsramme: post-birth
birth weight in grams, birth weight to gestational age ratio, and risk of low birth weight (<2500 grams)
post-birth
postpartum depression
Tidsramme: post-birth
incidence of self-reported postpartum depression
post-birth

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change in and level of perceived stress
Tidsramme: second trimester, third trimester, post-birth
self-report of perceived life stress
second trimester, third trimester, post-birth
change in and type(s) of coping
Tidsramme: second trimester, third trimester, post-birth
self-report of coping with salient stressful aspects of pregnancy and parenting
second trimester, third trimester, post-birth
change in and level of mindfulness
Tidsramme: second trimester, third trimester, post-birth
self-report of mindfulness of daily experiences
second trimester, third trimester, post-birth
change in and level of positive and negative emotion
Tidsramme: second trimester, third trimester, post-birth
self-report of intensity and frequency of positive and negative affect
second trimester, third trimester, post-birth
change in and level of pregnancy-related anxiety
Tidsramme: second trimester, third trimester
self-report of pregnancy-related anxiety
second trimester, third trimester
change in and level of depressive mood
Tidsramme: second trimester, third trimester
self-report of depressive mood
second trimester, third trimester
change in and levels of salivary cortisol
Tidsramme: second trimester, third trimester
waking, 30-minutes post-waking, and bed-time salivary cortisol
second trimester, third trimester
change in and level of adrenocorticotropic hormone (ACTH)
Tidsramme: second trimester, third trimester
adrenocorticotropic hormone (ACTH) assayed from blood plasma
second trimester, third trimester
change in and levels of corticotropin releasing hormone (CRH)
Tidsramme: second trimester, third trimester
corticotropin releasing hormone (CRH) assayed from blood plasma
second trimester, third trimester
change in and levels of blood pressure
Tidsramme: second trimester, third trimester
diastolic and systolic blood pressure
second trimester, third trimester

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Efterforskere

  • Ledende efterforsker: Larissa G Duncan, PhD, University of California, San Francisco

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2011

Primær færdiggørelse (Faktiske)

3. maj 2017

Studieafslutning (Faktiske)

3. maj 2017

Datoer for studieregistrering

Først indsendt

18. juli 2012

Først indsendt, der opfyldte QC-kriterier

18. juli 2012

Først opslået (Skøn)

20. juli 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • K01AT005270 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med For tidlig fødsel

Kliniske forsøg med CenteringPregnancy

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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CROs in Ghana

Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner