Pilot Trial of CenteringPregnancy With Mindfulness Skills
13 février 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
49
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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California
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San Francisco, California, États-Unis, 94115
- University of California, San Francisco
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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.
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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 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.
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Comparateur actif: 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.
|
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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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preterm birth
Délai: post-birth
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gestational age at birth and risk of preterm birth (<37 weeks)
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post-birth
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birth weight
Délai: post-birth
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birth weight in grams, birth weight to gestational age ratio, and risk of low birth weight (<2500 grams)
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post-birth
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postpartum depression
Délai: post-birth
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incidence of self-reported postpartum depression
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post-birth
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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change in and level of perceived stress
Délai: second trimester, third trimester, post-birth
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self-report of perceived life stress
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second trimester, third trimester, post-birth
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change in and type(s) of coping
Délai: second trimester, third trimester, post-birth
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self-report of coping with salient stressful aspects of pregnancy and parenting
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second trimester, third trimester, post-birth
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change in and level of mindfulness
Délai: second trimester, third trimester, post-birth
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self-report of mindfulness of daily experiences
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second trimester, third trimester, post-birth
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change in and level of positive and negative emotion
Délai: second trimester, third trimester, post-birth
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self-report of intensity and frequency of positive and negative affect
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second trimester, third trimester, post-birth
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change in and level of pregnancy-related anxiety
Délai: second trimester, third trimester
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self-report of pregnancy-related anxiety
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second trimester, third trimester
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change in and level of depressive mood
Délai: second trimester, third trimester
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self-report of depressive mood
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second trimester, third trimester
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change in and levels of salivary cortisol
Délai: second trimester, third trimester
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waking, 30-minutes post-waking, and bed-time salivary cortisol
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second trimester, third trimester
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change in and level of adrenocorticotropic hormone (ACTH)
Délai: second trimester, third trimester
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adrenocorticotropic hormone (ACTH) assayed from blood plasma
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second trimester, third trimester
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change in and levels of corticotropin releasing hormone (CRH)
Délai: second trimester, third trimester
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corticotropin releasing hormone (CRH) assayed from blood plasma
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second trimester, third trimester
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change in and levels of blood pressure
Délai: second trimester, third trimester
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diastolic and systolic blood pressure
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second trimester, third trimester
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Larissa G Duncan, PhD, University of California, San Francisco
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2011
Achèvement primaire (Réel)
3 mai 2017
Achèvement de l'étude (Réel)
3 mai 2017
Dates d'inscription aux études
Première soumission
18 juillet 2012
Première soumission répondant aux critères de contrôle qualité
18 juillet 2012
Première publication (Estimation)
20 juillet 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 février 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 février 2020
Dernière vérification
1 février 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- K01AT005270 (Subvention/contrat des NIH des États-Unis)
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