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| ID | Type | Description | Link |
|---|---|---|---|
| FP00000002 | Other Grant/Funding Number | BioNexus KC | |
| IRB STUDY00149318 | Other Identifier | The University of Kansas Medical Center |
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| Name | Class |
|---|---|
| BioNexus KC | UNKNOWN |
| Blue Cross Blue Shield | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doula-Enhanced Care Group | Experimental | This group received doula-enhanced care along with routine pregnancy care. |
|
| Routine Pregnancy Care Group | No Intervention | This group received routine pregnancy care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doula Care | Behavioral | Participants assigned to the Doula care group received care from the doula pre, during, and post delivery. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Study enrollment through 6-weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 14-28 weeks GA through delivery |
| Perinatal Outcome - Number of Participants With Preterm <37 Weeks Births |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Martin, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Routine Pregnancy Care Group | This group received routine pregnancy care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Routine Pregnancy Care Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | score on a scale | Study enrollment through 6-weeks postpartum |
|
Baseline visit (14-28 weeks GA) to 6-weeks postpartum.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Angela Martin, MD | The University of Kansas Medical Center | 913-588-6259 | amartin18@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2023 | Dec 16, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 6, 2023 | Dec 16, 2025 | ICF_001.pdf |
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Assess preterm <37 weeks births by collecting data from their patient surveys and chart. |
| 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. | 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. | 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. | Birth/delivery |
| Neonatal Morbidity | Assess neonatal morbidity by collecting neonatal ICU admissions | 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. | 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. | 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. | 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. | 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. | 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. | Birth through 6-weeks postpartum |
This group received routine pregnancy care. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Advanced Maternal Age (AMA) | Count of Participants | Participants |
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| Nulliparous | Count of Participants | Participants |
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| History of Cesarean Section | Count of Participants | Participants |
|
| OG001 | Routine Pregnancy Care Group | This group received routine pregnancy care. |
|
|
| Primary | 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. | Posted | Mean | Full Range | score on a scale | Study enrollment through 6-weeks postpartum |
|
|
|
| Secondary | 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) | Posted | Mean | Full Range | Weeks | 14-28 weeks GA through delivery |
|
|
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| Secondary | Perinatal Outcome - Number of Participants With Preterm <37 Weeks Births | Assess preterm <37 weeks births by collecting data from their patient surveys and chart. | Posted | Count of Participants | Participants | 14-28 weeks GA through delivery |
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| Secondary | Perinatal Outcome - Number of Participants With Cesarean Sections | Assess cesarean sections by collecting data from their patient surveys and chart. | Posted | Count of Participants | Participants | 14-28 weeks GA through delivery |
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| Secondary | Perinatal Outcome - Number of Participants With Gestational Hypertension/Preeclampsia | Assess gestational hypertension/preeclampsia diagnosis by collecting data from their patient surveys and chart. | Posted | Count of Participants | Participants | 14-28 weeks GA through delivery |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Birth/delivery |
|
|
|
| Secondary | Neonatal Morbidity | Assess neonatal morbidity by collecting neonatal ICU admissions | Posted | Count of Participants | Participants | Birth through 6-weeks postpartum |
|
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| Secondary | 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. | Posted | Mean | Full Range | score on a scale | Study enrollment through delivery |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | score on a scale | Birth (delivery) through 6-weeks postpartum |
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|
|
| Secondary | 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. | Posted | Mean | Full Range | score on a scale | Delivery through hospital discharge |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | Morphine Milliequivalents (MME) | Delivery through hospital discharge |
|
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| Secondary | 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. | Posted | Count of Participants | Participants | Birth |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Birth through 6-weeks postpartum |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Routine Pregnancy Care Group | This group received routine pregnancy care. | 0 | 14 | 0 | 14 | 0 | 14 |
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