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Pregnancy, High RiskNCT03833245

Optimizing Pregnancy and Treatment Interventions for Moms 2.0

A study testing Patient Navigation in people with Pregnancy, High Risk and Opioid-Related Disorders, run by University of Utah at 2 sites 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

The US opioid epidemic continues to result in serious health consequences for pregnant and postpartum women. In the US from 2007 to 2012, an average of 21,000 pregnant women each year reported past month opioid misuse. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Patient Navigation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
2 sitesUnited States
Study dates
11 Mar 2019to 1 Oct 2022
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

  • Adult (≥18 years)
  • English speaking
  • Pregnant women (pregnancy status verified by gestational age >6 weeks from last menstrual period confirmed by ultrasound)
  • OUD verified by examination of medical records for an OUD diagnosis, urine toxicology, and the Diagnostic and Statistical Manual of Mental Disorders (DSM) Checklist (modified from the DSM-IV to confirm current diagnosis for substance use disorders)
  • Plan to carry their babies to delivery verified by patient self report
  • Participant Exclusion Criteria
Show all 13Show fewer
  • Experienced a psychotic or a manic episode in the last 30 days documented in their medical record
  • Beyond the 25th week of gestation
  • Cannot provide collateral contact information of 2 persons,
  • Cannot provide a reliable phone number,
  • Plan to move from the area within 2 months of their delivery will or 6 months after not be included in the study
  • Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
  • Other factors that would cause harm or increased risk to the participant or close contacts, or preclude the participant's full adherence with or completion of the study

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Magee Women's Hospital

    Pittsburgh, Pennsylvania, 15213

  • University of Utah

    Salt Lake City, Utah, 84108

Other trials in United States

About this study

The US opioid epidemic continues to result in serious health consequences for pregnant and postpartum women. In the US from 2007 to 2012, an average of 21,000 pregnant women each year reported past month opioid misuse. This study aims to provide rapid and targeted primary prevention activities aimed at assisting pregnant women with opioid use disorder (OUD) to become linked to and retained in treatment in order to reduce harms to them (including overdose) and their offspring.

Read the detailed description

Age adjusted rates for overdose among women in the US increased more than six-fold from 1.4 in 1999 to 8.5 in 2016. Examining Pennsylvania (PA) and Utah (UT; the states where recruitment will happen in this study), these states have some of the highest rates of overdose among women compared to other US states. Specifically, PA's overdose rate among women surpassed the national average in 2016, and rates of overdose death in UT among women have ranged 2-9 times higher than the national rate between 2009 to 2016. Both PA and Utah are among the states with the highest opioid prescribing to pregnant women, with Utah being the highest in the nation (41.6%). Prenatal opioid use disorder (OUD) in the US has brought serious health consequences for mother and infant-including preterm delivery, low birth weight, NAS, and poor breastfeeding, and includes substantial expenditures of health care resources. Chances for HIV (OR=20.3, 95% CI = 13.8-29.7) and hepatitis C virus (OR=150.2. 95% CI = 120.9-186.6) infection among women with OUD are markedly higher than for those without OUD. Pregnant women with OUD have high rates of psychiatric illnesses, such as depression and anxiety, and other substance use disorders (SUDs), with particularly high rates of smoking (>80%). Neonatal abstinence syndrome (NAS), an opioid withdrawal syndrome among neonates, has also increased substantially from 3.4/1000 births in 2009 to 5.8/1000 births in 2012. Poly-substance use among pregnant women with OUD has also been associated with higher levels of needed medications to treat NAS and longer duration of NAS treatment. Smoking combined with opioid use during pregnancy has likewise been related to longer duration of NAS treatment, greater NAS severity, and higher levels of medication needed to treat NAS symptomology. Any prenatal opioid use also has been associated with birth defects, including neural tube defects, conoventricular septal defects, atrioventricular septal defects, hypoplastic left heart syndrome, and gastroschisis. Compared with women without any SUDs, children born to mothers with OUD or OUD plus other SUDs also have been documented to have lower cognitive functioning as they mature. Problems resulting from illicit and prescription OUD also result in significant social issues. Pregnant women with OUD have been observed to have financial and housing instability, challenges related to employment, and involvement with the legal system.

Being tested
Patient Navigation
Medical subject headings
Opioid-Related Disorders

What participants receive

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

  • Patient NavigationBehavioural

    The patient navigation (PN) intervention will initiate following participant recruitment. It is important to note that PN sessions do not strictly coincide with specific weeks of pregnancy since the women can be recruited up to ≤25 weeks of gestation. The prenatal portion of the intervention includes 10 sessions delivered within approximately 14 weeks. The postnatal portion of the intervention will be delivered as 4 sessions over 8 weeks. Women who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce abstinence and treatment retention. All contact will be reported by staff in a patient contact log developed for the study that will be used to quantify level of patient contact.

Study groups in NCT03833245
Study groupRoleWhat they receive
ControlNo interventionThe standard care condition includes brief case management and referral. The brief case management involves the participant speaking to a hospital social worker who conducts a patient needs assessment in the areas of behavioral health and social services. All patients will be referred to MAT and any identified behavioral health or social service needs.
Patient NavigationExperimentalThe prenatal portion of the intervention includes 10 sessions delivered within approximately 14 weeks. The postnatal portion of the intervention will be delivered as 4 sessions over 8 weeks. Women who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce abstinence and treatment retention.
Receives: Behavioral: Patient Navigation

What is being measured

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

  1. Opioid Use Disorder (OUD) and Other Substance Use Disorder (SUD) Treatment Linkage/Retention

    Percentage of days of days of attending outpatient and inpatient Substance Use Disorder treatment.

    Measured: 6 months

  2. Adherence to Medication-Assisted Treatment (MAT) Medication Use Section

    Adherence to MAT will be assessed through the treatment services review (TSR-6) medication use section defined by percentage days of attendance.

    Measured: 6 months

Secondary outcomes (1)

  1. Adequacy of Prenatal Care

    Capturing prenatal care will be accessed through the adequacy of prenatal care utilization index (APNCU). This index will be used to determine the sufficiency of prenatal care participants received.

    Measured: 1 week

Timeline

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

  1. First posted6 Feb 2019
  2. Study start11 Mar 2019
  3. Primary completion1 Oct 2022
  4. Study completion1 Oct 2022

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03833245
Sponsor's protocol ID
116398
Status last verified
Jan 2025
First submitted
28 Jan 2019
Last updated
3 Feb 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cochran G, Smid MC, Krans EE, Yu Z, Carlston K, White A, Abdulla W, Baylis J, Charron E, Okifugi A, Gordon AJ, Lundahl B, Silipigni J, Seliski N, Haaland B, Tarter R. Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial. Addiction. 2024 Mar;119(3):544-556. doi: 10.1111/add.16364. Epub 2023 Oct 20.

    PubMed 37859587

  • Charles JE, Baylis J, Smid MC, Cochran G. Nonfatal Overdoses Among Pregnant Individuals With Opioid Use Disorder. Obstet Gynecol. 2023 May 1;141(5):961-963. doi: 10.1097/AOG.0000000000005129. Epub 2023 Apr 5.

    PubMed 37103536

  • Bryan MA, Mallik D, Cochran G, Lundahl B. Mindfulness and Savoring: A Commentary on Savoring Strategies and Their Implications for Addiction Treatment. Subst Use Misuse. 2022;57(5):822-826. doi: 10.1080/10826084.2022.2046090. Epub 2022 Mar 10.

    PubMed 35349380

  • Cochran G, Smid MC, Krans EE, Bryan MA, Gordon AJ, Lundahl B, Silipigni J, Haaland B, Tarter R. A pilot multisite study of patient navigation for pregnant women with opioid use disorder. Contemp Clin Trials. 2019 Dec;87:105888. doi: 10.1016/j.cct.2019.105888. Epub 2019 Nov 12.

    PubMed 31731006

Questions about this trial

What is this clinical trial studying?

A study testing Patient Navigation in people with Pregnancy, High Risk and Opioid-Related Disorders, run by University of Utah at 2 sites 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 13 inclusion and 0 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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 3 Feb 2025). 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?

Opioid Use Disorder (OUD) and Other Substance Use Disorder (SUD) Treatment Linkage/Retention (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT03833245, which also lists 4 linked publications.

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 3 Feb 2025.

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