Providing Expanded Continuous Labor Support to Pregnant Women in New Mexico With Substance Use Disorders

Study Overview
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Brief Summary
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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.

Official Title
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Providing Expanded Continuous Labor Support to Pregnant Women in New Mexico With Substance Use Disorders

Conditions
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Pregnancy Related, Substance Use Disorders

Intervention / Treatment
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* Other: Continuous Labor Support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doula<br>Participants will be assigned a doula. | Other: Continuous Labor Support<br>* 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.<br>|
| No Intervention: Control<br>Participants will not be assigned a doula. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |