Trial Outcomes & Findings for Labor and Delivery Doula Program to Reduce Perinatal Morbidity and Mortality in Kansas (NCT NCT07157059)
NCT ID: NCT07157059
Last Updated: 2026-02-19
Results Overview
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.
COMPLETED
NA
30 participants
Study enrollment through 6-weeks postpartum
2026-02-19
Participant Flow
Participant milestones
| Measure |
Doula-Enhanced Care Group
This group received doula-enhanced care along with routine pregnancy care.
Doula Care: Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
|
Routine Pregnancy Care Group
This group received routine pregnancy care.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Doula-Enhanced Care Group
This group received doula-enhanced care along with routine pregnancy care.
Doula Care: Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
|
Routine Pregnancy Care Group
This group received routine pregnancy care.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
Baseline Characteristics
Labor and Delivery Doula Program to Reduce Perinatal Morbidity and Mortality in Kansas
Baseline characteristics by cohort
| Measure |
Doula-Enhanced Care Group
n=12 Participants
This group received doula-enhanced care along with routine pregnancy care.
Doula Care: Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
|
Routine Pregnancy Care Group
n=14 Participants
This group received routine pregnancy care.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=4 Participants
|
14 Participants
|
26 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
28 years
n=4 Participants
|
29 years
|
28.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=4 Participants
|
14 Participants
|
26 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=4 Participants
|
14 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=4 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=4 Participants
|
14 participants
|
26 participants
n=4 Participants
|
|
Advanced Maternal Age (AMA)
|
3 Participants
n=4 Participants
|
1 Participants
|
4 Participants
n=4 Participants
|
|
Nulliparous
|
7 Participants
n=4 Participants
|
4 Participants
|
11 Participants
n=4 Participants
|
|
History of Cesarean Section
|
3 Participants
n=4 Participants
|
3 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Study enrollment through 6-weeks postpartumAssess 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.
Outcome measures
| Measure |
Routine Pregnancy Care Group
n=14 Participants
This group received routine pregnancy care.
|
Doula-Enhanced Care Group
n=12 Participants
This group received doula-enhanced care along with routine pregnancy care.
Doula Care: Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
|
|---|---|---|
|
Perceptions of Provider Communication
|
1.86 score on a scale
Interval 1.0 to 5.0
|
1.42 score on a scale
Interval 1.0 to 5.0
|
PRIMARY outcome
Timeframe: Study enrollment through 6-weeks postpartumAssess 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.
Outcome measures
| Measure |
Routine Pregnancy Care Group
n=14 Participants
This group received routine pregnancy care.
|
Doula-Enhanced Care Group
n=12 Participants
This group received doula-enhanced care along with routine pregnancy care.
Doula Care: Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
|
|---|---|---|
|
Perceptions of Maternal Care
|
4.36 score on a scale
Interval 1.0 to 5.0
|
4.50 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: 14-28 weeks GA through deliveryAssess 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)
Outcome measures
| Measure |
Routine Pregnancy Care Group
n=14 Participants
This group received routine pregnancy care.
|
Doula-Enhanced Care Group
n=12 Participants
This group received doula-enhanced care along with routine pregnancy care.
Doula Care: Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
|
|---|---|---|
|
Perinatal Outcome - Gestational Age (GA) at Delivery
|
38.1 Weeks
Interval 29.4 to 40.5
|
37.5 Weeks
Interval 31.6 to 40.4
|
SECONDARY outcome
Timeframe: 14-28 weeks GA through deliveryAssess preterm \<37 weeks births by collecting data from their patient surveys and chart.
Outcome measures
| Measure |
Routine Pregnancy Care Group
n=14 Participants
This group received routine pregnancy care.
|
Doula-Enhanced Care Group
n=12 Participants
This group received doula-enhanced care along with routine pregnancy care.
Doula Care: Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
|
|---|---|---|
|
Perinatal Outcome - Number of Participants With Preterm <37 Weeks Births
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 14-28 weeks GA through deliveryAssess cesarean sections by collecting data from their patient surveys and chart.
Outcome measures
| Measure |
Routine Pregnancy Care Group
n=14 Participants
This group received routine pregnancy care.
|
Doula-Enhanced Care Group
n=12 Participants
This group received doula-enhanced care along with routine pregnancy care.
Doula Care: Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
|
|---|---|---|
|
Perinatal Outcome - Number of Participants With Cesarean Sections
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 14-28 weeks GA through deliveryAssess gestational hypertension/preeclampsia diagnosis by collecting data from their patient surveys and chart.
Outcome measures
| Measure |
Routine Pregnancy Care Group
n=14 Participants
This group received routine pregnancy care.
|
Doula-Enhanced Care Group
n=12 Participants
This group received doula-enhanced care along with routine pregnancy care.
Doula Care: Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
|
|---|---|---|
|
Perinatal Outcome - Number of Participants With Gestational Hypertension/Preeclampsia
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Birth/deliveryAssess 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.
Outcome measures
| Measure |
Routine Pregnancy Care Group
n=14 Participants
This group received routine pregnancy care.
|
Doula-Enhanced Care Group
n=12 Participants
This group received doula-enhanced care along with routine pregnancy care.
Doula Care: Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
|
|---|---|---|
|
Neonatal Morbidity
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Birth through 6-weeks postpartumAssess neonatal morbidity by collecting neonatal ICU admissions
Outcome measures
| Measure |
Routine Pregnancy Care Group
n=14 Participants
This group received routine pregnancy care.
|
Doula-Enhanced Care Group
n=12 Participants
This group received doula-enhanced care along with routine pregnancy care.
Doula Care: Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
|
|---|---|---|
|
Neonatal Morbidity
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Study enrollment through deliveryAssess 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.
Outcome measures
| Measure |
Routine Pregnancy Care Group
n=13 Participants
This group received routine pregnancy care.
|
Doula-Enhanced Care Group
n=10 Participants
This group received doula-enhanced care along with routine pregnancy care.
Doula Care: Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
|
|---|---|---|
|
Antepartum Depression
|
10.4 score on a scale
Interval 1.0 to 27.0
|
7.8 score on a scale
Interval 0.0 to 20.0
|
SECONDARY outcome
Timeframe: Birth (delivery) through 6-weeks postpartumAssess 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.
Outcome measures
| Measure |
Routine Pregnancy Care Group
n=14 Participants
This group received routine pregnancy care.
|
Doula-Enhanced Care Group
n=10 Participants
This group received doula-enhanced care along with routine pregnancy care.
Doula Care: Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
|
|---|---|---|
|
Postpartum Depression
|
6.9 score on a scale
Interval 0.0 to 20.0
|
7.7 score on a scale
Interval 0.0 to 19.0
|
SECONDARY outcome
Timeframe: Delivery through hospital dischargeAssess 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.
Outcome measures
| Measure |
Routine Pregnancy Care Group
n=14 Participants
This group received routine pregnancy care.
|
Doula-Enhanced Care Group
n=12 Participants
This group received doula-enhanced care along with routine pregnancy care.
Doula Care: Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
|
|---|---|---|
|
Maternal Pain Management
|
7.86 score on a scale
Interval 4.0 to 10.0
|
6.83 score on a scale
Interval 3.0 to 9.0
|
SECONDARY outcome
Timeframe: Delivery through hospital dischargeDescription: 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.
Outcome measures
| Measure |
Routine Pregnancy Care Group
n=14 Participants
This group received routine pregnancy care.
|
Doula-Enhanced Care Group
n=12 Participants
This group received doula-enhanced care along with routine pregnancy care.
Doula Care: Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
|
|---|---|---|
|
Maternal Pain Management
|
32.25 Morphine Milliequivalents (MME)
Interval 0.0 to 147.5
|
25.00 Morphine Milliequivalents (MME)
Interval 0.0 to 75.0
|
SECONDARY outcome
Timeframe: BirthAssess lactation status by asking and recording participants response about initiating lactation and breastfeeding during their labor and delivery admission.
Outcome measures
| Measure |
Routine Pregnancy Care Group
n=14 Participants
This group received routine pregnancy care.
|
Doula-Enhanced Care Group
n=12 Participants
This group received doula-enhanced care along with routine pregnancy care.
Doula Care: Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
|
|---|---|---|
|
Lactation Status - Number of Participants Lactating and Breastfeeding
|
13 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Birth through 6-weeks postpartumAssess 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.
Outcome measures
| Measure |
Routine Pregnancy Care Group
n=14 Participants
This group received routine pregnancy care.
|
Doula-Enhanced Care Group
n=12 Participants
This group received doula-enhanced care along with routine pregnancy care.
Doula Care: Participants assigned to the Doula care group received care from the doula pre, during, and post delivery.
|
|---|---|---|
|
Lactation Status - Number of Participants Lactating and Breastfeeding After L&D Discharge
|
9 Participants
|
7 Participants
|
Adverse Events
Doula-Enhanced Care Group
Routine Pregnancy Care Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Angela Martin, MD
The University of Kansas Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place