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

NCT ID: NCT03808909

Last Updated: 2022-11-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-06

Study Completion Date

2019-07-19

Brief Summary

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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

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Conditions

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Pregnancy Related Substance Use Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Doula

Participants will be assigned a doula.

Group Type EXPERIMENTAL

Continuous Labor Support

Intervention Type 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.

Control

Participants will not be assigned a doula.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Pilar Sanjuan

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5U54MD004811-10

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-280

Identifier Type: -

Identifier Source: org_study_id

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