RECRUITING

Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will be a 12-month prospective, genotype-blinded longitudinal observational study with current standard of clinical care. This study will enroll 100 pregnant women with OUD at UPMC Hospitals with its high volumes. Because of the observational nature of the study, the anticipated dropout rate will be ≤ 20%. Investigators expect the effective sample size of evaluable patients will be 200 with longitudinal data.

Official Title

Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy

Quick Facts

Study Start:2023-08-28
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05942313

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant women with OUD and their infant
  2. * Currently on BUP/METH for OUD
  3. * Enrolled in prenatal opioid maintenance program
  4. * Age \>18 years
  5. * Singleton pregnancy
  6. * Planned delivery at UPMC's Magee Womans Hospital
  7. * Positive opioid urine screen results
  1. * Serious maternal medical illness as deemed by the PI that would make it challenging to comply with study procedures
  2. * HIV or AIDS
  3. * Known major fetal congenital abnormalities

Contacts and Locations

Study Contact

Amy Monroe, MPH, MBA
CONTACT
412-623-6382
monroeal@upmc.edu
Carly Riedmann, MPH
CONTACT
412-623-4147
riedmannca@upmc.edu

Principal Investigator

Ilana Hull, MD
PRINCIPAL_INVESTIGATOR
Univrsity of Pittsburgh / UPMC Magee Womens Hospital

Study Locations (Sites)

UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Ilana Hull

  • Ilana Hull, MD, PRINCIPAL_INVESTIGATOR, Univrsity of Pittsburgh / UPMC Magee Womens Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-28
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2023-08-28
Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Pregnancy Related