Viewing Study NCT01646463



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Study NCT ID: NCT01646463
Status: COMPLETED
Last Update Posted: 2020-02-17
First Post: 2012-07-18

Brief Title: Pilot Trial of CenteringPregnancy With Mindfulness Skills
Sponsor: University of California San Francisco
Organization: University of California San Francisco

Study Overview

Official Title: Integrative Stress Reduction for Maternal-Child Health
Status: COMPLETED
Status Verified Date: 2020-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: In the US rates of preterm birth and low birth weight have increased over the past 30 years Poor birth outcomes are especially high among racialethnic 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None