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

Not Applicable

Completed

• Conditions: Pregnancy Related; Prenatal Care; Doula Care; Black Maternal and Infant Health

• Registration Number: NCT07157059
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-12
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-18
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perceptions of provider communication	14-28 weeks GA through 6-weeks postpartum	Assess perceptions of provider communication using Likert-scale surveys (including some yes/no questions and comments).
Perceptions of maternal care	14-28 weeks GA through 6-weeks postpartum	Assess perceptions of maternal care using Likert-scale surveys (including some yes/no questions and comments).

Secondary Outcome Measures

Name	Time	Method
Perinatal outcome - gestational age (GA) at delivery	14-28 weeks GA through delivery	Assess gestational age (GA) at delivery by collecting data from their patient surveys and chart.
Perinatal outcome - preterm <37 weeks births	14-28 weeks GA through delivery	Assess preterm \<37 weeks births by collecting data from their patient surveys and chart.
Perinatal outcome - cesarean sections	14-28 weeks GA through delivery	Assess cesarean sections by collecting data from their patient surveys and chart.
Perinatal outcome - gestational hypertension/Preeclampsia	14-28 weeks GA through delivery	Assess gestational hypertension/Preeclampsia by collecting data from their patient surveys and chart.
Neonatal morbidity	Birth through 6-weeks postpartum	Assess neonatal morbidity by collecting neonatal APAGAR scores and neonatal ICU admissions
Antepartum depression	14-28 weeks GA through delivery	Assess depression using Edinburgh depression screening tool
Postpartum depression	Birth (delivery) through 6-weeks postpartum	Assess depression using Edinburgh depression screening tool
Maternal pain management	Birth through 6-weeks postpartum	Assess pain management via postpartum pain perception scores and total morphine milliequivalent used.
Lactation Status	Birth through 6-weeks postpartum	Assess lactation status was asked and recorded for patients during their labor and delivery admission and postpartum visits

Trial Locations

Locations (1)

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States