Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes (Mother/BabyOUD)

Effects of 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).

Study Overview

• Status: Recruiting
• Conditions: Opioid-use Disorder; Opioid Use, Unspecified; Buprenorphine Dependence
• Intervention / Treatment: Drug: Subutex / Buprenorphine; Diagnostic test: Fetal & Neonatal MRI; Diagnostic test: DNA/Genetic/Pharmacokenetic Blood Draws

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Senthil Sadhasivam, MD, MPH; Phone Number: 4126474484; Email: sadhasivams@upmc.edu
• Study Contact Backup: Name: Carly Riedmann, MPH; Phone Number: 4126234147; Email: riedmannca@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Recruiting
      • UPMC Children's Hospital
      • Contact: Carly Riedmann, MPH; Phone Number: 4126234147; Email: riedmannca@upmc.edu
      • Contact: Senthil M Sadhasivam, MD, MPH; Phone Number: 412-647-4484; Email: sadhasivams@upmc.edu
      • Principal Investigator: Senthilkumar Sadhasivam, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine for opioid use disorder.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant Mothers with Opioid Use Disorder; Planned recruitment of 200 pregnant (<16weeks) mothers who have opioid use disorder and are taking buprenorphine	Drug: Subutex / Buprenorphine; Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.; Diagnostic test: Fetal & Neonatal MRI; Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.; Diagnostic test: DNA/Genetic/Pharmacokenetic Blood Draws; 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.
Pregnant Mothers; Planned recruitment of 100 pregnant (>16weeks) mothers who do not have any history of opioid use disorder.	Diagnostic test: Fetal & Neonatal MRI; Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.; Diagnostic test: DNA/Genetic/Pharmacokenetic Blood Draws; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of opioid misuse severity using assessments	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.	5 years
Pharmacological treatment for neonatal abstinence syndrome	Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse effects of buprenorphine using MRI	Incidence of adverse effects of buprenorphine use on fetal and placental changes using MRI.	5 years
Concentration of long-term neurodevelopmental outcomes using assessments	Concentration of long-term neurodevelopmental outcomes in neonates using the Ages and Stages Questionnaire and the Baileys follow-up assessment.	5 years

Collaborators and Investigators

• Sponsor: Senthil Sadhasivam
• Collaborators: National Institute on Drug Abuse (NIDA); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Senthil Sadhasivam, MD, MPH, University of Pittsburgh, UPMC

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2018
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 24, 2018
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 22, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Buprenorphine; Subutex; Pregnant with Opioid Use Disorder; Opioid Use Disorder ( OUD); Pregnant taking buprenorphine/subutex
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: STUDY21110112; 1R01HD096800-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No