NCT03808909

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

February 6, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2019

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

November 30, 2022

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

January 14, 2019

Results QC Date

July 21, 2022

Last Update Submit

November 28, 2022

Conditions

Pregnancy RelatedSubstance Use Disorders

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Remain in the Study

    Number of participants who complete the 2 week follow-up

    2 week postpartum follow-up assessment

Secondary Outcomes (3)

  • Alternative Birth Outcome

    birth

  • Postpartum Posttraumatic Stress Disorder Checklist

    2 week postpartum follow-up assessment

  • Participant Satisfaction

    2 week postpartum follow-up assessment

Other Outcomes (7)

  • Percentage of Days With Drinking or Substance Use

    2 week postpartum follow-up assessment

  • Mother's Autonomy During Birth

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

  • Postpartum Depression

    2 week postpartum follow-up assessment

  • +4 more other outcomes

Study Arms (2)

Doula

EXPERIMENTAL

Participants will be assigned a doula.

Other: Continuous Labor Support

Control

NO INTERVENTION

Participants will not be assigned a doula.

Interventions

Continuous Labor SupportOTHER

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.

Doula

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Limitations and Caveats

This was a pilot feasibility study. We only collected data for 10 participants: 9 in the experimental condition - with a doula and 1 in the control condition. Thus, the data is primarily descriptive and there are not enough participants to conduct statistical comparisons between groups. This was because funding was only available for 12 mos and negotiations between community partners and the university delayed the start of data collection by more than 6 months.

Results Point of Contact

Title
Pilar Sanjuan
Organization
University of New Mexico, Health Sciences Center
psanjuan@salud.unm.edu
505/272-7055

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

January 14, 2019

First Posted

January 18, 2019

Study Start

February 6, 2019

Primary Completion

June 30, 2019

Study Completion

July 19, 2019

Last Updated

November 30, 2022

Results First Posted

November 30, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)