Labor and Delivery Doula Program to Reduce Perinatal Morbidity and Mortality in Kansas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-12

Study Completion Date

2024-11-01

Brief Summary

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The study was done to learn how doula-enhanced care provided to Black birthing people improved perceived communication and quality care.

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Detailed Description

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Conditions

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Pregnancy Related Doula Care Black Maternal and Infant Health Prenatal Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Doula-Enhanced Care Group

This group received doula-enhanced care along with routine pregnancy care.

Group Type EXPERIMENTAL

Doula Care

Intervention Type BEHAVIORAL

Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.

Routine Pregnancy Care Group

This group received routine pregnancy care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Doula Care

Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Black birthing people
* Received care and plan to delivery at the University of Kansas Medical Center
* Scored positive to social determinants of health screener
* Gestational age between 14-27.6 weeks at enrollment

Exclusion Criteria

* Pregnancy not viable or pregnancy not intrauterine on ultrasound
* Patients who are not willing to be randomized into not receiving doula enhanced
* Patients who do not plan to delivery at the University of Kansas Health System
* Non-Black birthing people.
* Planned cesarean section
* Patients with a known major fetal anomaly
* Non-English speaking

Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes