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

Primary Purpose

Pregnancy Related, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Labor Support
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pregnancy Related

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of New Mexico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Doula

Control

Arm Description

Participants will be assigned a doula.

Participants will not be assigned a doula.

Outcomes

Primary Outcome Measures

Number of Participants Who Remain in the Study
Number of participants who complete the 2 week follow-up

Secondary Outcome Measures

Alternative Birth Outcome
Number of participants with preterm, c-section, fetal demise, still birth, or other potential birth outcomes
Postpartum Posttraumatic Stress Disorder Checklist
PTSD Checklist - 5 (PCL-5) Higher scores indicate a worse outcome Range of scale = 0 - 80
Participant Satisfaction
Study specific participant satisfaction - debriefing form - qualitative data. No qualitative analyses have been conducted with this data.

Full Information

First Posted
January 14, 2019
Last Updated
November 28, 2022
Sponsor
University of New Mexico
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03808909
Brief Title
Providing Expanded Continuous Labor Support to Pregnant Women in New Mexico With Substance Use Disorders
Acronym
Project_SuM
Official Title
Providing Expanded Continuous Labor Support to Pregnant Women in New Mexico With Substance Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
July 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Substance Use Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Doula
Arm Type
Experimental
Arm Description
Participants will be assigned a doula.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will not be assigned a doula.
Intervention Type
Other
Intervention Name(s)
Continuous Labor Support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Who Remain in the Study
Description
Number of participants who complete the 2 week follow-up
Time Frame
2 week postpartum follow-up assessment
Secondary Outcome Measure Information:
Title
Alternative Birth Outcome
Description
Number of participants with preterm, c-section, fetal demise, still birth, or other potential birth outcomes
Time Frame
birth
Title
Postpartum Posttraumatic Stress Disorder Checklist
Description
PTSD Checklist - 5 (PCL-5) Higher scores indicate a worse outcome Range of scale = 0 - 80
Time Frame
2 week postpartum follow-up assessment
Title
Participant Satisfaction
Description
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
Other Pre-specified Outcome Measures:
Title
Percentage of Days With Drinking or Substance Use
Description
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
Title
Mother's Autonomy During Birth
Description
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
Title
Postpartum Depression
Description
Edinburgh Postpartum Depression Scale Higher scores are a worse outcome Scale range = 0-30
Time Frame
2 week postpartum follow-up assessment
Title
Breastfeeding Update
Description
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
Title
Neonatal Abstinence Syndrome
Description
NAS diagnosis
Time Frame
neonatal
Title
Length of NICU Stay
Description
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
Title
Social Support - NIH Toolbox
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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