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Completed

NCT Number: NCT07157059

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

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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Key information

Age range

16 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doula Care

Behavioral

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

Primary outcomes

  1. Perceptions of Provider Communication

    Time frame: Study enrollment through 6-weeks postpartum

    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.

  2. Perceptions of Maternal Care

    Time frame: Study enrollment through 6-weeks postpartum

    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.

Secondary outcomes

  1. Perinatal Outcome - Gestational Age (GA) at Delivery

    Time frame: 14-28 weeks GA through 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)

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

    Time frame: 14-28 weeks GA through delivery

    Assess preterm <37 weeks births by collecting data from their patient surveys and chart.

  3. Perinatal Outcome - Number of Participants With Cesarean Sections

    Time frame: 14-28 weeks GA through delivery

    Assess cesarean sections by collecting data from their patient surveys and chart.

  4. Perinatal Outcome - Number of Participants With Gestational Hypertension/Preeclampsia

    Time frame: 14-28 weeks GA through delivery

    Assess gestational hypertension/preeclampsia diagnosis by collecting data from their patient surveys and chart.

  5. Neonatal Morbidity

    Time frame: Birth/delivery

    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.

  6. Neonatal Morbidity

    Time frame: Birth through 6-weeks postpartum

    Assess neonatal morbidity by collecting neonatal ICU admissions

  7. Antepartum Depression

    Time frame: Study enrollment through delivery

    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.

  8. Postpartum Depression

    Time frame: Birth (delivery) through 6-weeks postpartum

    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.

  9. Maternal Pain Management

    Time frame: Delivery through hospital discharge

    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.

  10. Maternal Pain Management

    Time frame: Delivery through hospital discharge

    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.

  11. Lactation Status - Number of Participants Lactating and Breastfeeding

    Time frame: Birth

    Assess lactation status by asking and recording participants response about initiating lactation and breastfeeding during their labor and delivery admission.

  12. Lactation Status - Number of Participants Lactating and Breastfeeding After L&D Discharge

    Time frame: Birth through 6-weeks postpartum

    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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • BioNexus KC
  • Blue Cross Blue Shield

Registry information

Acronym: Doula

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2025
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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