Pregnancy RelatedProject_SuMNCT03808909

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

A study testing Continuous Labor Support in people with Pregnancy Related and Substance Use Disorders, run by University of New Mexico at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pregnancy Related, Substance Use Disorders
What is being tested?: Continuous Labor Support
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: 6 Feb 2019to 19 Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of New Mexico
Albuquerque, New Mexico, 87131

Other trials in United States

About this study

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.

Conditions: Pregnancy Related, Substance Use Disorders
Being tested: Continuous Labor Support
Medical subject headings: Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT03808909
Study group	Role	What they receive
Doula	Experimental	Participants will be assigned a doula. Receives: Other: Continuous Labor Support
Control	No intervention	Participants will not be assigned a doula.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Remain in the Study
Number of participants who complete the 2 week follow-up
Measured: 2 week postpartum follow-up assessment

Secondary outcomes (3)

Alternative Birth Outcome
Number of participants with preterm, c-section, fetal demise, still birth, or other potential birth outcomes
Measured: birth
Postpartum Posttraumatic Stress Disorder Checklist
PTSD Checklist - 5 (PCL-5) Higher scores indicate a worse outcome Range of scale = 0 - 80
Measured: 2 week postpartum follow-up assessment
Participant Satisfaction
Study specific participant satisfaction - debriefing form - qualitative data. No qualitative analyses have been conducted with this data.
Measured: 2 week postpartum follow-up assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Feb 201919 Jul 2019

First posted18 Jan 2019
Study start6 Feb 2019
Primary completion30 Jun 2019
Study completion19 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03808909
Sponsor's protocol ID: 18-280
Other IDs: 5U54MD004811-10
Acronym: Project_SuM
Status last verified: Nov 2022
First submitted: 14 Jan 2019
Last updated: 30 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pregnancy Related trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Providing Expanded Continuous Labor Support to Pregnant Women in New Mexico With Substance Use Disorders
ClinicalTrials.gov ID: NCT03808909
Acronym / sponsor ID: Project_SuM / 18-280
Conditions: Pregnancy Related, Substance Use Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: University of New MexicoUniversity, hospital or other
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Study start: 6 Feb 2019 (actual)
Primary completion: 30 Jun 2019 (actual)
Study completion: 19 Jul 2019 (actual)
First posted: 18 Jan 2019 (actual)
Results: Posted 30 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Doula	Experimental	Other: Continuous Labor SupportParticipants will be assigned a doula.
Control	No intervention	–Participants will not be assigned a doula.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Continuous Labor SupportParticipants 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.	Other	Doula

Primary outcome

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

3 secondary outcomes

Alternative Birth Outcome
Time frame: birth
Postpartum Posttraumatic Stress Disorder Checklist
Time frame: 2 week postpartum follow-up assessment
Participant Satisfaction
Time frame: 2 week postpartum follow-up assessment

Results and safety

Results posted to the registry on 30 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Doula	12	9
Control	1	1

Primary outcome: Number of Participants Who Remain in the Study

Time frame: 2 week postpartum follow-up assessment. Count of participants. Unit: Participants

Measure	Doula n = 9	Control n = 1
Value	9	1

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Doula	0 of 0	0 of 0	0
No Doula	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Labor Support in people with Pregnancy Related and Substance Use Disorders, run by University of New Mexico at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Remain in the Study (time frame: 2 week postpartum follow-up assessment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03808909.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.