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| ID | Type | Description | Link |
|---|---|---|---|
| 5U54MD004811-10 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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This study will determine the feasibility of offering expanded continuous labor support by trauma- and addiction-trained medical paraprofessionals (i.e. doulas) at no cost to pregnant women receiving care for substance use disorders (SUD). The long-term goal of this transdisciplinary multilevel intervention is ultimately to reduce a major existing behavioral health disparity in the state. This cross-campus multi-disciplinary collaboration, is in partnership with Young Women United (a research and policy organization in NM) and doulas of the UNM Birth Companion Program. Through this partnership, women receiving combined OB/SUD treatment at the Milagro Program at UNMHSC will be offered expanded doula services.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doula | Experimental | Participants will be assigned a doula. |
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| Control | No Intervention | Participants will not be assigned a doula. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Labor Support | Other | Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Remain in the Study | Number of participants who complete the 2 week follow-up | 2 week postpartum follow-up assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Alternative Birth Outcome | Number of participants with preterm, c-section, fetal demise, still birth, or other potential birth outcomes | birth |
| Postpartum Posttraumatic Stress Disorder Checklist |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Days With Drinking or Substance Use | Using the timeline followback we will calculate average percentage of days of alcohol or other substance use for each group from pregnancy recognition to the 2 week follow-up. | 2 week postpartum follow-up assessment |
| Mother's Autonomy During Birth |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Doula | Participants will be assigned a doula. Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery. |
| FG001 | Control | Participants will not be assigned a doula. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Doula | Participants will be assigned a doula. Continuous Labor Support: Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery. |
| BG001 | Control |
| 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 | Number of Participants Who Remain in the Study | Number of participants who complete the 2 week follow-up | Posted | Count of Participants | Participants | 2 week postpartum follow-up assessment |
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Adverse event data was not collected as there was no data monitoring plan because this research was not considered more than minimal risk.
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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 | Participants with a doula | 0 |
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This was a pilot feasibility study. We only collected data for 10 participants: 9 in the experimental condition - with a doula and 1 in the control condition. Thus, the data is primarily descriptive and there are not enough participants to conduct statistical comparisons between groups. This was because funding was only available for 12 mos and negotiations between community partners and the university delayed the start of data collection by more than 6 months.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pilar Sanjuan | University of New Mexico, Health Sciences Center | 505/272-7055 | psanjuan@salud.unm.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 | Jul 12, 2018 | Jul 21, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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PTSD Checklist - 5 (PCL-5) Higher scores indicate a worse outcome Range of scale = 0 - 80
| 2 week postpartum follow-up assessment |
| Participant Satisfaction | Study specific participant satisfaction - debriefing form - qualitative data. No qualitative analyses have been conducted with this data. | 2 week postpartum follow-up assessment |
Mother's Autonomy in Decision Making Questionnaire Higher scores indicate more autonomy (better outcome) Scale range = 7 - 42 |
| queries feelings during labor and birth but is administered at 2 week follow-up |
| Postpartum Depression | Edinburgh Postpartum Depression Scale Higher scores are a worse outcome Scale range = 0-30 | 2 week postpartum follow-up assessment |
| Breastfeeding Update | Using a study specific form we will calculate the number of participants who attempted breastfeeding after the birth of the baby | 2 week postpartum follow-up assessment |
| Neonatal Abstinence Syndrome | NAS diagnosis | neonatal |
| Length of NICU Stay | Average length of time that the infant remains hospitalized in the NICU after the birth | from birth through study completion, an average of 3 months |
| Social Support - NIH Toolbox | Average score for social support on NIH toolbox Total of Emotional, Friend, and Instrumental Social support scales Higher scores indicated a better outcome Scale range = 24 - 120 | 2 week postpartum follow-up assessment |
Participants will not be assigned a doula. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 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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| Edinburgh Postpartum Depression Scale | Mean | Standard Deviation | units on a scale |
|
| PTSD Checklist - 5 (PCL-5) | The PCL-5 is a 20-item questionnaire, corresponding to the DSM-5 symptom criteria for PTSD. The wording of PCL-5 items reflects both changes to existing symptoms and the addition of new symptoms in DSM-5. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Initial research suggests that a PCL-5 cutoff score between 31-33 is indicative of probable PTSD across samples. See: https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp | Mean | Standard Deviation | units on a scale |
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| Percent Drinking Days | Percent drinking days from pregnancy recognition to baseline assessment collected with the Timeline Followback. See SOBELL, L.C., SOBELL, M.B., LEO, G.I. and CANCILLA, A. (1988), Reliability of a Timeline Method: assessing normal drinkers' reports of recent drinking and a comparative evaluation across several populations. British Journal of Addiction, 83: 393-402. https://doi-org.libproxy.unm.edu/10.1111/j.1360-0443.1988.tb00485.x | Mean | Standard Deviation | Percent of days |
|
| Percent Substance Use Days | Sum of all percent substance use days - can be more than 100% if multiple substances used during the same time frame (from pregnancy recognition to baseline assessment). SOBELL, L.C., SOBELL, M.B., LEO, G.I. and CANCILLA, A. (1988), Reliability of a Timeline Method: assessing normal drinkers' reports of recent drinking and a comparative evaluation across several populations. British Journal of Addiction, 83: 393-402. https://doi-org.libproxy.unm.edu/10.1111/j.1360-0443.1988.tb00485.x | Mean | Standard Deviation | Percent of days |
|
| NIH Toolbox Emotional Support | Measures perceived emotional support. Scale range = 5-40. Higher scores indicate more perceived support. See https://www.healthmeasures.net/explore-measurement-systems/nih-toolbox | Mean | Standard Deviation | units on a scale |
|
| NIH Toolbox Friendship Support | Measures perceived support from friends. Scale range = 5-40. Higher scores indicate more perceived support from friends. See: https://www.healthmeasures.net/explore-measurement-systems/nih-toolbox | Mean | Standard Deviation | units on a scale |
|
| NIH Toolbox Instrumental Support | Measures perceived instrumental support. Range = 5-40. Higher scores indicate more perceived support. See https://www.healthmeasures.net/explore-measurement-systems/nih-toolbox | Mean | Standard Deviation | units on a scale |
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| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Alternative Birth Outcome | Number of participants with preterm, c-section, fetal demise, still birth, or other potential birth outcomes | Posted | Count of Participants | Participants | birth |
|
|
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| Secondary | Postpartum Posttraumatic Stress Disorder Checklist | PTSD Checklist - 5 (PCL-5) Higher scores indicate a worse outcome Range of scale = 0 - 80 | Posted | Mean | Standard Deviation | score on a scale | 2 week postpartum follow-up assessment |
|
|
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| Secondary | Participant Satisfaction | Study specific participant satisfaction - debriefing form - qualitative data. No qualitative analyses have been conducted with this data. | Participants who were assigned a doula were included in this analysis | Posted | Number | percentage of participants | 2 week postpartum follow-up assessment |
|
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| Other Pre-specified | Percentage of Days With Drinking or Substance Use | Using the timeline followback we will calculate average percentage of days of alcohol or other substance use for each group from pregnancy recognition to the 2 week follow-up. | Posted | Mean | Standard Deviation | percentage of days | 2 week postpartum follow-up assessment |
|
|
|
| Other Pre-specified | Mother's Autonomy During Birth | Mother's Autonomy in Decision Making Questionnaire Higher scores indicate more autonomy (better outcome) Scale range = 7 - 42 | Posted | Mean | Standard Deviation | score on a scale | queries feelings during labor and birth but is administered at 2 week follow-up |
|
|
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| Other Pre-specified | Postpartum Depression | Edinburgh Postpartum Depression Scale Higher scores are a worse outcome Scale range = 0-30 | Posted | Mean | Standard Deviation | score on a scale | 2 week postpartum follow-up assessment |
|
|
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| Other Pre-specified | Breastfeeding Update | Using a study specific form we will calculate the number of participants who attempted breastfeeding after the birth of the baby | Posted | Count of Participants | Participants | 2 week postpartum follow-up assessment |
|
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| Other Pre-specified | Neonatal Abstinence Syndrome | NAS diagnosis | Posted | Count of Participants | Participants | neonatal |
|
|
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| Other Pre-specified | Length of NICU Stay | Average length of time that the infant remains hospitalized in the NICU after the birth | Posted | Mean | Standard Deviation | Days | from birth through study completion, an average of 3 months |
|
|
|
| Other Pre-specified | Social Support - NIH Toolbox | Average score for social support on NIH toolbox Total of Emotional, Friend, and Instrumental Social support scales Higher scores indicated a better outcome Scale range = 24 - 120 | Posted | Mean | Standard Deviation | score on a scale | 2 week postpartum follow-up assessment |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | No Doula | Participants without a doula | 0 | 0 | 0 | 0 | 0 | 0 |
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| Fetal Demise |
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| Stillbirth |
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| Percent of participants who would want a doula at another birth |
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| Percent of participants who felt having a doula made pregnancy much easier |
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| Percent of participants who felt the doula understood their needs very well |
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| Percent of participants who were very satisfied with the doula experience |
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| Breastfeeding at discharge |
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| Exclusive breastfeeding |
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