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Observational Study on Opioid Use Disorder in Pregnancy

This study is looking at how to predict and prevent problems for mothers and babies when the mother has opioid use disorder (OUD) during pregnancy. Researchers are observing pregnant women who are already taking buprenorphine or methadone for OUD. They want to understand if certain genes and exposure to opioids before birth are linked to the mother relapsing (using opioids again) or to the baby developing Neonatal Opioid Withdrawal Syndrome (NOWS). The study will follow 100 pregnant women and their babies at UPMC Hospitals. Success will be measured by how often mothers relapse up to three months after delivery and how often babies have NOWS at delivery. This is an observational study, meaning you would receive your usual care.

Study design
This is an observational study involving 100 pregnant women, meaning researchers will observe participants receiving their standard medical care without assigning specific treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Mothers will be followed for opioid relapse until three months after delivery, and babies will be assessed for NOWS at delivery.

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NCT05942313

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

Recruiting
Not specifiedAges 18+Observational
Ilana Hull
~100 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Buprenorphine/ Methadone exposure

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of maternal opioid relapse
Measured over Measured from enrollment to 3-months post delivery
+1 more outcome measured

Conditions

Opioid Use Disorder
Pregnancy Related

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Opioid Use DisorderPregnancy

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

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

Who to contact

Amy Monroe, MPH, MBA
[email protected]
412-623-6382
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Pregnant women with OUD and their infant
Currently on BUP/METH for OUD
Enrolled in prenatal opioid maintenance program
Age \>18 years
Singleton pregnancy
Planned delivery at UPMC's Magee Womans Hospital
Positive opioid urine screen results

Exclusion

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

What this trial measures

  • Incidence of maternal opioid relapseMeasured from enrollment to 3-months post delivery

    Measured via binary response, yes/no

  • Incidence of NOWSMeasured at delivery

    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