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Completed

NCT Number: NCT03808909

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

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.

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Key information

Conditions

Pregnancy Related Chemically-Induced Disorders Mental Disorders Substance Use Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Labor Support

Other

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 outcomes

  1. Number of Participants Who Remain in the Study

    Time frame: 2 week postpartum follow-up assessment

    Number of participants who complete the 2 week follow-up

Secondary outcomes

  1. Alternative Birth Outcome

    Time frame: birth

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

  2. Postpartum Posttraumatic Stress Disorder Checklist

    Time frame: 2 week postpartum follow-up assessment

    PTSD Checklist - 5 (PCL-5) Higher scores indicate a worse outcome Range of scale = 0 - 80

  3. Participant Satisfaction

    Time frame: 2 week postpartum follow-up assessment

    Study specific participant satisfaction - debriefing form - qualitative data. No qualitative analyses have been conducted with this data.

Other outcomes

  1. Percentage of Days With Drinking or Substance Use

    Time frame: 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 from pregnancy recognition to the 2 week follow-up.

  2. Mother's Autonomy During Birth

    Time frame: queries feelings during labor and birth but is administered at 2 week follow-up

    Mother's Autonomy in Decision Making Questionnaire Higher scores indicate more autonomy (better outcome) Scale range = 7 - 42

  3. Postpartum Depression

    Time frame: 2 week postpartum follow-up assessment

    Edinburgh Postpartum Depression Scale Higher scores are a worse outcome Scale range = 0-30

  4. Breastfeeding Update

    Time frame: 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

  5. Neonatal Abstinence Syndrome

    Time frame: neonatal

    NAS diagnosis

  6. Length of NICU Stay

    Time frame: from birth through study completion, an average of 3 months

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

  7. Social Support - NIH Toolbox

    Time frame: 2 week postpartum follow-up assessment

    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

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: Project_SuM

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2019
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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