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

Not Applicable

Completed

• Conditions: Pregnancy Related; Substance Use Disorders
• Interventions: Other: Continuous Labor Support

• Registration Number: NCT03808909
• Lead Sponsor: University of New Mexico

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-18
• Study Start: 2019-02-06
• Primary Completion: 2019-06-30
• Study Completion: 2019-07-19
• Results First Submitted: 2022-07-21
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-28
• Last Update Submitted: 2022-11-28
• Results First Posted: 2022-11-30
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doula	Continuous Labor Support	Participants will be assigned a doula.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Alternative Birth Outcome	birth	Number of participants with preterm, c-section, fetal demise, still birth, or other potential birth outcomes

Trial Locations

Locations (1)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States