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

Sponsor
University of New Mexico (Other)
Overall Status
Completed
CT.gov ID
NCT03808909
Collaborator
(none)
13
1
2
5.4
2.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Continuous Labor Support
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Providing Expanded Continuous Labor Support to Pregnant Women in New Mexico With Substance Use Disorders
Actual Study Start Date :
Feb 6, 2019
Actual Primary Completion Date :
Jun 30, 2019
Actual Study Completion Date :
Jul 19, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of participants who remain in the study [2 week postpartum follow-up assessment]

    Number of participants in the intervention arm who ask for the doula at delivery intake. Number of participants who complete the 2 week follow-up

Secondary Outcome Measures

  1. Adverse birth outcome [birth]

    Number of participants with preterm, c-section, fetal demise, still birth, or other potentially adverse birth outcomes

Other Outcome Measures

  1. Percent drinking and substance use days [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 at birth and at 2 week follow-up.

  2. 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

  3. Postpartum posttraumatic stress disorder [2 week postpartum follow-up assessment]

    PTSD Checklist - 5 (PCL-5)

  4. Postpartum depression [2 week postpartum follow-up assessment]

    Edinburgh Postpartum Depression Scale

  5. 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

  6. Neonatal Abstinence Syndrome [from birth through study completion, an average of 3 months]

    Average hospital score for NAS

  7. Length of NICU stay [from birth through study completion, an average of 3 months]

    Average length of time that the infant remains hospitalized after the birth

  8. Social Support - NIH Toolbox [2 week postpartum follow-up assessment]

    Average score for social support on NIH toolbox

  9. Participant satisfaction [2 week postpartum follow-up assessment]

    Study specific participant satisfaction - debriefing form - qualitative data.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of New Mexico Albuquerque New Mexico United States 87131

Sponsors and Collaborators

  • University of New Mexico

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pilar Sanjuan, Research Assistant Professor, University of New Mexico
ClinicalTrials.gov Identifier:
NCT03808909
Other Study ID Numbers:
  • 18-280
First Posted:
Jan 18, 2019
Last Update Posted:
Sep 25, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 25, 2019