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出境医 / 临床实验 / Providing Expanded Continuous Labor Support to Pregnant Women in New Mexico With Substance Use Disorders (Project_SuM)

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

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
Pregnancy Related Substance Use Disorders Other: Continuous Labor Support Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : February 6, 2019
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : July 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 [ Time Frame: 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 [ Time Frame: 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 [ 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 at birth and at 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

  3. Postpartum posttraumatic stress disorder [ Time Frame: 2 week postpartum follow-up assessment ]
    PTSD Checklist - 5 (PCL-5)

  4. Postpartum depression [ Time Frame: 2 week postpartum follow-up assessment ]
    Edinburgh Postpartum Depression Scale

  5. 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

  6. Neonatal Abstinence Syndrome [ Time Frame: from birth through study completion, an average of 3 months ]
    Average hospital score for NAS

  7. 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 after the birth

  8. Social Support - NIH Toolbox [ Time Frame: 2 week postpartum follow-up assessment ]
    Average score for social support on NIH toolbox

  9. Participant satisfaction [ Time Frame: 2 week postpartum follow-up assessment ]
    Study specific participant satisfaction - debriefing form - qualitative data.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Tracking Information
First Submitted Date  ICMJE January 14, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE February 6, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2019) 		Number of participants who remain in the study [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2019) 		Adverse birth outcome [ Time Frame: birth ]
Number of participants with preterm, c-section, fetal demise, still birth, or other potentially adverse birth outcomes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 16, 2019)
  • Percent drinking and substance use days [ 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 at birth and at 2 week follow-up.
  • 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
  • Postpartum posttraumatic stress disorder [ Time Frame: 2 week postpartum follow-up assessment ]
    PTSD Checklist - 5 (PCL-5)
  • Postpartum depression [ Time Frame: 2 week postpartum follow-up assessment ]
    Edinburgh Postpartum Depression Scale
  • 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
  • Neonatal Abstinence Syndrome [ Time Frame: from birth through study completion, an average of 3 months ]
    Average hospital score for NAS
  • 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 after the birth
  • Social Support - NIH Toolbox [ Time Frame: 2 week postpartum follow-up assessment ]
    Average score for social support on NIH toolbox
  • Participant satisfaction [ Time Frame: 2 week postpartum follow-up assessment ]
    Study specific participant satisfaction - debriefing form - qualitative data.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Providing Expanded Continuous Labor Support to Pregnant Women in New Mexico With Substance Use Disorders
Official Title  ICMJE Providing Expanded Continuous Labor Support to Pregnant Women in New Mexico With Substance Use Disorders
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Pregnancy Related
  • Substance Use Disorders
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Doula
    Participants will be assigned a doula.
    Intervention: Other: Continuous Labor Support
  • No Intervention: Control
    Participants will not be assigned a doula.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2019) 		13
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2019) 		34
Actual Study Completion Date  ICMJE July 19, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03808909
Other Study ID Numbers  ICMJE 18-280
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pilar Sanjuan, University of New Mexico
Study Sponsor  ICMJE University of New Mexico
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of New Mexico
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP