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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Substance Use Disorders
• Intervention / Treatment: Other: Continuous Labor Support

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Doula; Participants will be assigned a doula.	Other: 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.
No Intervention: Control; Participants will not be assigned a doula.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of New Mexico
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): July 19, 2019

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 18-280; 5U54MD004811-10 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No