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NCT Number: NCT03923374

Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes

The objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution and infants at risk of significant neonatal abstinence syndrome (NAS).

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Key information

Conditions

Opioid-use Disorder Buprenorphine Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Use, Unspecified Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

UPMC Children's Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location status: Recruiting

Location contact

Carly Riedmann, MPH

CONTACT

[email protected]

4126234147

Senthil M Sadhasivam, MD, MPH

CONTACT

[email protected]

4126474484

Senthilkumar Sadhasivam, MD, MPH

PRINCIPAL_INVESTIGATOR

About this study

One of the greatest impacts on maternal/infant health in the United States today is mother's who have opioid use disorder also known as OUD. This study will look at how in-utero buprenorphine also known as subutex, effects both mother/fetus in prenatal stages with MRI's, blood draws, and a series of assessments. After the neonate is born, there will be follow-up with that baby for up to 2 years with another neonatal MRI, blood draws and infant/child assessments. Planning to enroll 200 mothers who have opioid use disorder and 100 mothers with no previous opioid use.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age greater 18 years
  • Currently taking Buprenorphine for Opioid Use Disorder and enrolled in a prenatal opioid maintenance program in the antenatal clinic at IU Health University Hospital.
  • Pregnant with single baby
  • Planned delivery at Methodist, University or Riley Hospital

Exclusion criteria

  • Serious maternal medical illness as deemed by study physician or investigator.
  • Known or suspected major fetal/neonatal congenital abnormalities.

Treatment and study plan

Subutex / Buprenorphine

Drug

Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.

Fetal & Neonatal MRI

Diagnostic Test

Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.

DNA/Genetic/Pharmacokenetic Blood Draws

Diagnostic Test

Throughout the pregnancy, Mothers will be participating in blood collection throughout the study. At enrollment, we will collect DNA, Genetic and PK blood specimens, then throughout the study, we will be collecting random PK samples.

Primary outcomes

  1. Incidence of opioid misuse severity using assessments

    Time frame: 5 years

    Incidence of opioid misuse severity and buprenorphine treatment response will be assessed by the treating physician using assessments such as Who Assist, TCU Motform, Adverse Childhood Experience Assessment, Ham-A and Ham-D.

  2. Pharmacological treatment for neonatal abstinence syndrome

    Time frame: 5 years

    Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment.

Secondary outcomes

  1. Incidence of adverse effects of buprenorphine using MRI

    Time frame: 5 years

    Incidence of adverse effects of buprenorphine use on fetal and placental changes using MRI.

  2. Concentration of long-term neurodevelopmental outcomes using assessments

    Time frame: 5 years

    Concentration of long-term neurodevelopmental outcomes in neonates using the Ages and Stages Questionnaire and the Baileys follow-up assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

Carly Riedmann, MPH

CONTACT

[email protected]

4126234147

Senthil Sadhasivam, MD, MPH

CONTACT

[email protected]

4126474484

Sponsors and collaborators

Lead sponsor

Senthil Sadhasivam

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes

Acronym: Mother/BabyOUD

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2019
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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