Pregnancy RelatedDoulaNCT07157059
Labor and Delivery Doula Program to Reduce Perinatal Morbidity and Mortality in Kansas
A study testing Doula Care in people with Pregnancy Related and Doula Care, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The study was done to learn how doula-enhanced care provided to Black birthing people improved perceived communication and quality care. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Doula Care, Black Maternal and Infant Health
- What is being tested?
- Doula Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The study was done to learn how doula-enhanced care provided to Black birthing people improved perceived communication and quality care.
- Being tested
- Doula Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doula CareBehavioural
Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
| Study group | Role | What they receive |
|---|---|---|
| Doula-Enhanced Care Group | Experimental | This group received doula-enhanced care along with routine pregnancy care. Receives: Behavioral: Doula Care |
| Routine Pregnancy Care Group | No intervention | This group received routine pregnancy care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Study enrollment through 6-weeks postpartum
Secondary outcomes (12)
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Birth/delivery
Neonatal Morbidity
Assess neonatal morbidity by collecting neonatal ICU admissions
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Birth through 6-weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start12 May 2023
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- BioNexus KC, Blue Cross Blue Shield
- Responsible party
- Sponsor
- Investigators
- Angela Martin, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157059
- Sponsor's protocol ID
- STUDY00161314
- Other IDs
- FP00000002, IRB STUDY00149318
- Acronym
- Doula
- Status last verified
- Jan 2026
- First submitted
- 18 Aug 2025
- Last updated
- 19 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Labor and Delivery Doula Program to Reduce Perinatal Morbidity and Mortality in Kansas
- ClinicalTrials.gov ID
- NCT07157059
- Acronym / sponsor ID
- Doula / STUDY00161314
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- BioNexus KC, Blue Cross Blue Shield
- Study start
- 12 May 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 5 Sep 2025 (actual)
- Results
- Posted 19 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was done to learn how doula-enhanced care provided to Black birthing people improved perceived communication and quality care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doula-Enhanced Care Group | Experimental | Behavioral: Doula CareThis group received doula-enhanced care along with routine pregnancy care. |
| Routine Pregnancy Care Group | No intervention | –This group received routine pregnancy care. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doula CareParticipants assigned to the Doula care group received care from the doula pre, during, and post delivery. | Behavioural | Doula-Enhanced Care Group |
Primary outcome
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.
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.
12 secondary outcomes
Perinatal Outcome - Gestational Age (GA) at Delivery
Time frame: 14-28 weeks GA through delivery
Perinatal Outcome - Number of Participants With Preterm <37 Weeks Births
Time frame: 14-28 weeks GA through delivery
Perinatal Outcome - Number of Participants With Cesarean Sections
Time frame: 14-28 weeks GA through delivery
Perinatal Outcome - Number of Participants With Gestational Hypertension/Preeclampsia
Time frame: 14-28 weeks GA through delivery
Neonatal Morbidity
Time frame: Birth/delivery
Neonatal Morbidity
Time frame: Birth through 6-weeks postpartum
Antepartum Depression
Time frame: Study enrollment through delivery
Postpartum Depression
Time frame: Birth (delivery) through 6-weeks postpartum
Maternal Pain Management
Time frame: Delivery through hospital discharge
Maternal Pain Management
Time frame: Delivery through hospital discharge
Lactation Status - Number of Participants Lactating and Breastfeeding
Time frame: Birth
Lactation Status - Number of Participants Lactating and Breastfeeding After L&D Discharge
Time frame: Birth through 6-weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Martin, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doula Care in people with Pregnancy Related and Doula Care, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceptions of Provider Communication (time frame: Study enrollment through 6-weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.