Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorIlana Hull
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women with OUD and their infant
Currently on BUP/METH for OUD
Enrolled in prenatal opioid maintenance program
Age >18 years
Disqualifiers
Serious maternal medical illness as deemed by the PI that would make it challenging to comply with study procedures
HIV or AIDS
Known major fetal congenital abnormalities
Trial population
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 with its high volumes. Because of the observational nature of the study, the anticipated dropout rate will be ≤ 20%. We expect the effective sample size of evaluable patients will be 200 with longitudinal data.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Buprenorphine/ Methadone exposure
DrugValidate candidate genes- and prenatal opioid exposure- related maternal relapse and NOWS outcome associations in pregnant women and their newborns.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Pregnant women with Opioid Use Disorder (OUD)1 intervention
Trial outcomes
Primary outcomes
1
Incidence of maternal opioid relapse
Measured via binary response, yes/no
Time frame
Measured from enrollment to 3-months post delivery2
Incidence of NOWS
Clinical definition of NOWS: Substance withdrawal encompasses a continuum of variable clinical expression from neonate to neonate; the diagnosis is not limited only to neonates who require pharmacotherapy. Incidence of NOWS measured by binary response, yes/no
Time frame
Measured at deliverySecondary outcomes
1
Severity of Maternal Opioid Relapse
Severity of maternal opioid relapse measured by requirement of medical treatment (binary response, yes/no)
Time frame
Measured from enrollment to 3-months post delivery2
Severity of NOWs
Severity of NOWs measured by the need for \>3 days of hospital stay (binary response, yes/no)
Time frame
Measured at deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Ilana Hull
Lead sponsor
University of Pittsburgh
Sponsor institution
National Institute on Drug Abuse (NIDA)
Collaborator
OpalGenix, Inc
Collaborator
Source ClinicalTrials.gov