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NCT01646463 · ClinicalTrials.gov registry record · NA

Pilot Trial of CenteringPregnancy With Mindfulness Skills

A NA study of Postpartum Depression and Premature Birth, sponsored by University of California, San Francisco.

Completed
Registry status
NA
Development phase
49
Enrollment target
1
Study location

NCT01646463: Completed NA study of Postpartum Depression and Premature Birth, sponsored by University of California, San Francisco.

NCT01646463 is a NA study of Postpartum Depression and Premature Birth that has completed, run by University of California, San Francisco. The registered enrollment target is 49 participants, below the 474-participant average among 47 other Postpartum Depression trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01646463, a NA study of Postpartum Depression and Premature Birth, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
NA
Development phase
49 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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

Conditions Studied

Postpartum Depression Premature Birth Low Birth Weight

Interventions

  • BEHAVIORAL CenteringPregnancy
  • BEHAVIORAL CenteringPregnancy with Mindfulness Skills

Study Locations (1)

California

  • University of California, San Francisco - San Francisco

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2011-01
Est. Completion 2017-05-03
Phase NA
University of California, San Francisco

1,713 total trials

What the finished NCT01646463 record still lists

NCT01646463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 474-participant average among 47 other Postpartum Depression trials with a reported enrollment target (90% lower).

The record links to 3 conditions, with Postpartum Depression appearing as the primary indexed condition, and to 2 interventions - of which CenteringPregnancy is the first listed.

NCT01646463 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT01646463 about?

NCT01646463 is a clinical study titled "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 ...

What is the current status of trial NCT01646463?

This trial is currently completed. It is a NA study. The enrollment target is 49 participants. The study started on 2011-01. Estimated completion is 2017-05-03.

What conditions does trial NCT01646463 study?

This clinical trial studies the following conditions: Postpartum Depression, Premature Birth, Low Birth Weight.

What interventions are being tested in trial NCT01646463?

The interventions under investigation include: CenteringPregnancy (BEHAVIORAL), CenteringPregnancy with Mindfulness Skills (BEHAVIORAL).

Who is sponsoring clinical trial NCT01646463?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01646463 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Postpartum Depression

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01646463's enrollment target sits among peer trials

49 40th of 47 higher than 8 of 47 other Postpartum Depression trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Postpartum Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01646463, the US trial registry maintained by the National Library of Medicine. NCT01646463 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.