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

Pregnancy Related Clinical Trial

— Project_SuM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03808909
• Other study ID #: 18-280
• Secondary ID: 5U54MD004811-10
• Status: Completed
• Phase: N/A
• Start date: February 6, 2019
• Est. completion date: July 19, 2019

Study information

• Verified date: November 2022
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 19, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Days With Drinking or Substance Use	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 week postpartum follow-up assessment
Other	Mother's Autonomy During Birth	Mother's Autonomy in Decision Making Questionnaire Higher scores indicate more autonomy (better outcome) Scale range = 7 - 42	queries feelings during labor and birth but is administered at 2 week follow-up
Other	Postpartum Depression	Edinburgh Postpartum Depression Scale Higher scores are a worse outcome Scale range = 0-30	2 week postpartum follow-up assessment
Other	Breastfeeding Update	Using a study specific form we will calculate the number of participants who attempted breastfeeding after the birth of the baby	2 week postpartum follow-up assessment
Other	Neonatal Abstinence Syndrome	NAS diagnosis	neonatal
Other	Length of NICU Stay	Average length of time that the infant remains hospitalized in the NICU after the birth	from birth through study completion, an average of 3 months
Other	Social Support - NIH Toolbox	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	2 week postpartum follow-up assessment
Primary	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	Alternative Birth Outcome	Number of participants with preterm, c-section, fetal demise, still birth, or other potential birth outcomes	birth
Secondary	Postpartum Posttraumatic Stress Disorder Checklist	PTSD Checklist - 5 (PCL-5) Higher scores indicate a worse outcome Range of scale = 0 - 80	2 week postpartum follow-up assessment
Secondary	Participant Satisfaction	Study specific participant satisfaction - debriefing form - qualitative data. No qualitative analyses have been conducted with this data.	2 week postpartum follow-up assessment