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

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Prenatal Care; Doula Care; Black Maternal and Infant Health
• Intervention / Treatment: Behavioral: Doula Care

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Doula-Enhanced Care Group; This group received doula-enhanced care along with routine pregnancy care.	Behavioral: Doula Care; Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
No Intervention: Routine Pregnancy Care Group; This group received routine pregnancy care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perinatal Outcome - Gestational Age (GA) at Delivery	Assess gestational age (GA) at delivery by collecting data from their patient surveys and chart. GA at delivery (write number with one decimal place - "weeks.days". For example, 23 weeks and 4 days = 23.4)	14-28 weeks GA through delivery
Perinatal Outcome - Number of Participants With Preterm <37 Weeks Births	Assess preterm <37 weeks births by collecting data from their patient surveys and chart.	14-28 weeks GA through delivery
Perinatal Outcome - Number of Participants With Cesarean Sections	Assess cesarean sections by collecting data from their patient surveys and chart.	14-28 weeks GA through delivery
Perinatal Outcome - Number of Participants With Gestational Hypertension/Preeclampsia	Assess gestational hypertension/preeclampsia diagnosis by collecting data from their patient surveys and chart.	14-28 weeks GA through delivery
Neonatal Morbidity	Assess neonatal morbidity by collecting neonatal 5-min Appearance, Pulse, Grimace, Activity, Respiration (APAGAR) score <7. Each of the five criteria can be scored 0-2 with a possible total test score ranging from 0-10 with three subcategories; reassuring: score 7-10, moderately abnormal: 4-6 and low: 0-3. A higher score indicates better neonatal outcomes.	Birth/delivery
Neonatal Morbidity	Assess neonatal morbidity by collecting neonatal ICU admissions	Birth through 6-weeks postpartum
Antepartum Depression	Assess antepartum depression using Edinburgh depression screening tool. Edinburgh score scale range is from 0 to 30, a lower score is better as it indicates a participant is less likely to experience depression; the test denotes the following scoring interpretations for total scores: 0-6: minimal depression, 7-13: mild depression, 14-19: moderate depression, 19-30: severe depression. Reporting mean score for the antepartum phase of the study; participants were 14-28 weeks gestation at their study enrollment visit and mean gestational age at delivery for the doula-enhanced group was 37 weeks 5days and 38 weeks 1day for the routine care group.	Study enrollment through delivery
Postpartum Depression	Assess postpartum depression using Edinburgh depression screening tool. Edinburgh score scale range is from 0 to 30, a lower score is better as it indicates a participant is less likely to experience depression; the test denotes the following scoring interpretations for total scores: 0-6: minimal depression, 7-13: mild depression, 14-19: moderate depression, 19-30: severe depression. Reporting mean score for the postpartum phase in study participation starting post-delivery during their hospital admission until 6-weeks postpartum.	Birth (delivery) through 6-weeks postpartum
Maternal Pain Management	Assess pain management by using the Numerical Rating Scale (NRS) was used for patient's perception of postpartum pain. Zero (0) is the minimum score, which represents the patient reporting no pain, 10 is the maximum score which represents the patient reporting the most intense pain possible. Lower scores are associated with lower postpartum pain perception (better outcome) and higher scores are associated with higher postpartum pain perception (worse outcome) from delivery (mean gestational age at delivery for the doula-enhanced group was 37 weeks 5days and 38 weeks 1day for the routine care group) until hospital discharge.	Delivery through hospital discharge
Maternal Pain Management	Description: Assess pain management via postpartum total morphine milliequivalent used per the patient's medical chart. Postpartum morphine milliequivalents are reported as the total oral pain medication administered during the postpartum period (this excludes variations in epidural infusion and medications received parenterally). Highest reported mean range pain rating reported by participants on a scale of 0 (no pain) to 10 (excessive pain) from delivery (mean gestational age at delivery for the doula-enhanced group was 37 weeks 5days and 38 weeks 1day for the routine care group) until hospital discharge.	Delivery through hospital discharge
Lactation Status - Number of Participants Lactating and Breastfeeding	Assess lactation status by asking and recording participants response about initiating lactation and breastfeeding during their labor and delivery admission.	Birth
Lactation Status - Number of Participants Lactating and Breastfeeding After L&D Discharge	Assess lactation status from birth after labor and delivery discharge to 6-week postpartum, by asking and recording participants' responses about their lactation and breastfeed state during their postpartum visits.	Birth through 6-weeks postpartum

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: BioNexus KC; Blue KC (Blue Cross Blue Shield)
• Investigators: Principal Investigator: Angela Martin, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: August 18, 2025
• First Submitted That Met QC Criteria: August 27, 2025
• First Posted (Actual): September 5, 2025

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00161314; FP00000002 (Other Grant/Funding Number: BioNexus KC); IRB STUDY00149318 (Other Identifier: The University of Kansas Medical Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No