Music Intervention for Preterm Birth

Last updated: May 5, 2026
Sponsor: Columbia University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Miscarriage

Treatment

Sham Control (SC)

Verbal Intervention (VI)

Music Intervention (MI)

Clinical Study ID

NCT05945264
ACYY0271
AAAU6262
R01MD016899
  • Ages 18-40
  • Female

Study Summary

This study will test a music intervention (MI) versus a sham control (SC) arm which only includes a verbal intervention, to determine if the effects of the music intervention will reduce the biological impact of chronic stress among pregnant Black women, reduce preterm birth, and improve infant outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Aged 18 to 40 years

  • Generally healthy pregnant women in the first trimester of pregnancy

Exclusion

Exclusion Criteria:

  • Non-pregnant women

  • Women with a chronic medical condition that could impact pregnancy health orduration

  • Women regularly taking any medications other than prenatal vitamins

Study Design

Total Participants: 142
Treatment Group(s): 3
Primary Treatment: Sham Control (SC)
Phase:
Study Start date:
May 26, 2026
Estimated Completion Date:
August 29, 2027

Study Description

Preterm birth occurs at unacceptably high rates in the United States, with Black women disproportionately affected. A long-recognized risk factor for preterm birth in this population is the relentless exposure to intersectional stress related to racial and sexual discrimination, poverty, and neighborhood disadvantage that Black women often experience from an early age. In this interdisciplinary study, the investigators bring together experts in preterm birth, music therapy, and metabolomics to address this health disparity by testing the efficacy of a live, culturally based music intervention to reduce the production of metabolites and metabolic pathways associated with chronic stress and thereby improve birth outcomes.

Connect with a study center

  • Columbia University Irving Medical Center/NYP

    New York, New York 10032
    United States

    Site Not Available

  • Columbia University Irving Medical Center/NewYork Presbyterian

    New York, New York 10032
    United States

    Site Not Available

  • Louis Armstrong Center for Music and Medicine at Mount Sinai Health System

    New York, New York 10003
    United States

    Site Not Available

  • Louis Armstrong Center for Music and Medicine at Mount Sinai Health System

    New York City, New York 10003
    United States

    Site Not Available

  • Columbia University Irving Medical Center/NewYork Presbyterian

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Louis Armstrong Center for Music and Medicine at Mount Sinai Health System

    New York 5128581, New York 5128638 10003
    United States

    Site Not Available

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