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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Study enrollment through 6-weeks postpartum

Results posted on

2026-02-19

Participant Flow

Participant milestones

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

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

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 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.

Outcome measures

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 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.

Outcome measures

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 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)

Outcome measures

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 delivery

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

Outcome measures

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 delivery

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

Outcome measures

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 delivery

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

Outcome measures

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/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.

Outcome measures

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 postpartum

Assess neonatal morbidity by collecting neonatal ICU admissions

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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: Birth

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

Outcome measures

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 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.

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Routine Pregnancy Care Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 913-588-6259

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place