Pregnancy Related, Substance Use Disorders
Conditions
Brief summary
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.
Interventions
OTHERContinuous 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.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of New Mexico
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 18 years old * able to participate in informed consent * able to read, write, and speak English * gestation of at least 26 weeks at baseline (necessary because of short duration of study) * plan to give birth at UNM.
Exclusion criteria
* active psychosis * current incarceration * identified by medical staff as unable for medical reasons to currently participate in the study * not interested in having doula support
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Remain in the Study | 2 week postpartum follow-up assessment | Number of participants who complete the 2 week follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alternative Birth Outcome | birth | Number of participants with preterm, c-section, fetal demise, still birth, or other potential birth outcomes |
| Postpartum Posttraumatic Stress Disorder Checklist | 2 week postpartum follow-up assessment | PTSD Checklist - 5 (PCL-5) Higher scores indicate a worse outcome Range of scale = 0 - 80 |
| Participant Satisfaction | 2 week postpartum follow-up assessment | Study specific participant satisfaction - debriefing form - qualitative data. No qualitative analyses have been conducted with this data. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Abstinence Syndrome | neonatal | NAS diagnosis |
| Percentage of Days With Drinking or Substance Use | 2 week postpartum follow-up assessment | 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. |
| Social Support - NIH Toolbox | 2 week postpartum follow-up assessment | 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 |
| Length of NICU Stay | from birth through study completion, an average of 3 months | Average length of time that the infant remains hospitalized in the NICU after the birth |
| Mother's Autonomy During Birth | queries feelings during labor and birth but is administered at 2 week follow-up | Mother's Autonomy in Decision Making Questionnaire Higher scores indicate more autonomy (better outcome) Scale range = 7 - 42 |
| Postpartum Depression | 2 week postpartum follow-up assessment | Edinburgh Postpartum Depression Scale Higher scores are a worse outcome Scale range = 0-30 |
| Breastfeeding Update | 2 week postpartum follow-up assessment | Using a study specific form we will calculate the number of participants who attempted breastfeeding after the birth of the baby |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| Control Participants will not be assigned a doula. | 1 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
Baseline characteristics
| Characteristic | Doula | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 1 Participants | 10 Participants |
| Edinburgh Postpartum Depression Scale | 12.11 units on a scale STANDARD_DEVIATION 5.6667 | 18 units on a scale STANDARD_DEVIATION 0 | 12.70 units on a scale STANDARD_DEVIATION 5.65784 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 1 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| NIH Toolbox Emotional Support | 33.00 units on a scale STANDARD_DEVIATION 6.727 | 9 units on a scale STANDARD_DEVIATION 0 | 30.60 units on a scale STANDARD_DEVIATION 9.891 |
| NIH Toolbox Friendship Support | 17.89 units on a scale STANDARD_DEVIATION 5.578 | 8 units on a scale STANDARD_DEVIATION 0 | 16.90 units on a scale STANDARD_DEVIATION 6.118 |
| NIH Toolbox Instrumental Support | 29.22 units on a scale STANDARD_DEVIATION 5.74 | 8 units on a scale STANDARD_DEVIATION 0 | 27.10 units on a scale STANDARD_DEVIATION 8.621 |
| Percent Drinking Days | 0 Percent of days STANDARD_DEVIATION 0 | 0 Percent of days STANDARD_DEVIATION 0 | 0 Percent of days STANDARD_DEVIATION 0 |
| Percent Substance Use Days | 52.75 Percent of days STANDARD_DEVIATION 56.372 | 0 Percent of days STANDARD_DEVIATION 0 | 47.47 Percent of days STANDARD_DEVIATION 55.704 |
| PTSD Checklist - 5 (PCL-5) | 35.56 units on a scale STANDARD_DEVIATION 23.591 | 23 units on a scale STANDARD_DEVIATION 0 | 34.30 units on a scale STANDARD_DEVIATION 22.593 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 1 Participants | 9 Participants |
| Region of Enrollment United States | 9 participants | 1 participants | 10 participants |
| Sex: Female, Male Female | 9 Participants | 1 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants Who Remain in the Study
Number of participants who complete the 2 week follow-up
Time frame: 2 week postpartum follow-up assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Doula | Number of Participants Who Remain in the Study | 9 Participants |
| Control | Number of Participants Who Remain in the Study | 1 Participants |
Secondary
Alternative Birth Outcome
Number of participants with preterm, c-section, fetal demise, still birth, or other potential birth outcomes
Time frame: birth
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Doula | Alternative Birth Outcome | C-section | 2 Participants |
| Doula | Alternative Birth Outcome | Fetal Demise | 0 Participants |
| Doula | Alternative Birth Outcome | Preterm Birth | 1 Participants |
| Doula | Alternative Birth Outcome | Stillbirth | 0 Participants |
| Control | Alternative Birth Outcome | Stillbirth | 0 Participants |
| Control | Alternative Birth Outcome | C-section | 1 Participants |
| Control | Alternative Birth Outcome | Preterm Birth | 0 Participants |
| Control | Alternative Birth Outcome | Fetal Demise | 0 Participants |
Secondary
Participant Satisfaction
Study specific participant satisfaction - debriefing form - qualitative data. No qualitative analyses have been conducted with this data.
Time frame: 2 week postpartum follow-up assessment
Population: Participants who were assigned a doula were included in this analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Doula | Participant Satisfaction | Percent of participants who found it very helpful emotionally to have a doula during labor/delivery | 89 percentage of participants |
| Doula | Participant Satisfaction | Percent of participants who found it very helpful physically to have a doula during labor/delivery | 89 percentage of participants |
| Doula | Participant Satisfaction | Percent of participants who found it very helpful socially to have a doula during labor/delivery | 100 percentage of participants |
| Doula | Participant Satisfaction | Percent of participants who would want a doula at another birth | 100 percentage of participants |
| Doula | Participant Satisfaction | Percent of participants who felt having a doula made pregnancy much easier | 89 percentage of participants |
| Doula | Participant Satisfaction | Percent of participants who felt the doula understood their needs very well | 89 percentage of participants |
| Doula | Participant Satisfaction | Percent of participants who were very satisfied with the doula experience | 100 percentage of participants |
Secondary
Postpartum Posttraumatic Stress Disorder Checklist
PTSD Checklist - 5 (PCL-5) Higher scores indicate a worse outcome Range of scale = 0 - 80
Time frame: 2 week postpartum follow-up assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Doula | Postpartum Posttraumatic Stress Disorder Checklist | 21.38 score on a scale | Standard Deviation 20.007 |
| Control | Postpartum Posttraumatic Stress Disorder Checklist | 50 score on a scale | Standard Deviation 0 |
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
Time frame: 2 week postpartum follow-up assessment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Doula | Breastfeeding Update | Breastfeeding intent | 3 Participants |
| Doula | Breastfeeding Update | Breastfeeding initiation | 9 Participants |
| Doula | Breastfeeding Update | Breastfeeding at discharge | 9 Participants |
| Doula | Breastfeeding Update | Exclusive breastfeeding | 2 Participants |
| Control | Breastfeeding Update | Exclusive breastfeeding | 0 Participants |
| Control | Breastfeeding Update | Breastfeeding intent | 1 Participants |
| Control | Breastfeeding Update | Breastfeeding at discharge | 1 Participants |
| Control | Breastfeeding Update | Breastfeeding initiation | 1 Participants |
Other Pre-specified
Length of NICU Stay
Average length of time that the infant remains hospitalized in the NICU after the birth
Time frame: from birth through study completion, an average of 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Doula | Length of NICU Stay | 11.56 Days | Standard Deviation 14.32 |
| Control | Length of NICU Stay | 4 Days | Standard Deviation 0 |
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
Time frame: queries feelings during labor and birth but is administered at 2 week follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Doula | Mother's Autonomy During Birth | 30.8889 score on a scale | Standard Deviation 11.66667 |
| Control | Mother's Autonomy During Birth | 38 score on a scale | Standard Deviation 0 |
Other Pre-specified
Neonatal Abstinence Syndrome
NAS diagnosis
Time frame: neonatal
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Doula | Neonatal Abstinence Syndrome | 6 Participants |
| Control | Neonatal Abstinence Syndrome | 0 Participants |
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.
Time frame: 2 week postpartum follow-up assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Doula | Percentage of Days With Drinking or Substance Use | 19.85 percentage of days | Standard Deviation 44.509 |
| Control | Percentage of Days With Drinking or Substance Use | 0 percentage of days | Standard Deviation 0 |
Other Pre-specified
Postpartum Depression
Edinburgh Postpartum Depression Scale Higher scores are a worse outcome Scale range = 0-30
Time frame: 2 week postpartum follow-up assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Doula | Postpartum Depression | 8.56 score on a scale | Standard Deviation 6.579 |
| Control | Postpartum Depression | 18 score on a scale | Standard Deviation 0 |
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
Time frame: 2 week postpartum follow-up assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Doula | Social Support - NIH Toolbox | 82.3333 score on a scale | Standard Deviation 19.62142 |
| Control | Social Support - NIH Toolbox | 25 score on a scale | Standard Deviation 0 |