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NCT05945264NARecruiting

Music Intervention for Preterm Birth

Columbia University

Start Date

9/29/2026

Completion Date

8/29/2027

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to 40 years

Inclusion Criteria * Aged 18 to 40 years * Generally healthy pregnant women in the first trimester of pregnancy Exclusion Criteria: * Non-pregnant women * Women with a chronic medical condition that could impact pregnancy health or duration * Women regularly taking any medications other than prenatal vitamins

Interventions

BEHAVIORAL

Music Intervention (MI)

OTHER

Sham Control (SC)

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Conditions

Preterm Birth

Locations

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

New York, New York 10003

United States

Columbia University Irving Medical Center/NewYork Presbyterian

New York, New York 10032

United States