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

NCT07157059 | Completed Results

• 3 other identifiers: STUDY00161314FP00000002IRB STUDY00149318
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy Related; Doula Care; Prenatal Care; Black Maternal and Infant Health

Outcome Measures

Primary Outcomes (2)

• Perceptions of Provider Communication

  Assess patient's perception of their quality of communication with their provider using a Likert scale survey (ie. did the patient feel comfortable asking their prenatal provider questions regarding their health, did the patient feel listened to by their provider. Survey scale was 1 to 5 and correlated with agreement or disagreement. Reporting Likert's mean score as surveys were collected at three study timepoints (1. Baseline at study enrollment, 2. Immediate postdelivery, 3. 6-weeks postpartum); higher mean scores indicated more responses in disagreement.

  Study enrollment through 6-weeks postpartum

• Perceptions of Maternal Care

  Assess patient's perceptions of maternal care using a Likert scale survey (i.e. their physician spending time with the patient talking to them about their labor and delivery expectations) Survey scale was 1 to 5 and correlated with agreement or disagreement. Reporting Likert's mean score as surveys were collected at three study timepoints (1. Baseline at study enrollment, 2. Immediately post-delivery, 3. 6-weeks postpartum); higher mean scores indicated more responses in disagreement.

  Study enrollment through 6-weeks postpartum

Secondary Outcomes (12)

• Perinatal Outcome - Gestational Age (GA) at Delivery

  14-28 weeks GA through delivery

• Perinatal Outcome - Number of Participants With Preterm <37 Weeks Births

  14-28 weeks GA through delivery

• Perinatal Outcome - Number of Participants With Cesarean Sections

  14-28 weeks GA through delivery

• Perinatal Outcome - Number of Participants With Gestational Hypertension/Preeclampsia

  14-28 weeks GA through delivery

• Neonatal Morbidity

  Birth/delivery

Study Arms (2)

Doula-Enhanced Care Group

EXPERIMENTAL

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

Behavioral: Doula Care

Routine Pregnancy Care Group

NO INTERVENTION

This group received routine pregnancy care.

Interventions

Doula Care BEHAVIORAL

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

Doula-Enhanced Care Group

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• BioNexus KC: collaborator
• Blue KC (Blue Cross Blue Shield): collaborator

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Results Point of Contact

• Title: Dr. Angela Martin, MD
• Organization: The University of Kansas Medical Center

amartin18@kumc.edu

913-588-6259

Study Officials

• Angela Martin, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 5, 2025
• Study Start: May 12, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 19, 2026
• Results First Posted: February 19, 2026

Record last verified: 2026-01

Locations

US (1)