Status:

RECRUITING

Building TrUst and UNiting Teams Through DouLa partnErship - BUNDLE

Lead Sponsor:

Medical College of Wisconsin

Conditions:

Pregnancy Related

Eligibility:

FEMALE

18-65 years

Phase:

NA

Brief Summary

The BUNDLE study is a prospective mixed-methods study focused on the early integration of community doula into prenatal care. The study will have three phases: Phase 1 is the qualitative phase of cond...

Detailed Description

The BUNDLE study is a prospective mixed-methods study focused on the early integration of community doula into prenatal care. The investigators will pursue the following aims using a multidisciplinary...

Eligibility Criteria

Inclusion

  • Self-reported Black or African American
  • Pregnant with singleton gestation
  • Has an established OBGY at Froedtert \& the Medical College of Wisconsin (F\&MCW) Health System

Exclusion

  • Planning to deliver outside of F\&MCW Health System
  • Receiving support beyond routing prenatal care, such as group prenatal care or has their own doula
  • Inability or unwillingness to provide informed consent

Key Trial Info

Start Date :

January 2 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2030

Estimated Enrollment :

412 Patients enrolled

Trial Details

Trial ID

NCT05993689

Start Date

January 2 2025

End Date

June 30 2030

Last Update

May 30 2025

Active Locations (1)

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1

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226-3522