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

Opioid-use Disorder Clinical Trial

— Mother/BabyOUD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03923374
• Other study ID #: STUDY21110112
• Secondary ID: 1R01HD096800-01
• Status: Recruiting
• Start date: September 15, 2018
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: Senthil Sadhasivam, MD, MPH
• Phone: 4126474484
• Email: sadhasivams[@]upmc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Buprenorphine Dependence
• Opioid Use, Unspecified
• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UPMC Children's Hospital	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Senthil Sadhasivam	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pharmacological treatment for neonatal abstinence syndrome	Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment.	5 years
Secondary	Incidence of adverse effects of buprenorphine using MRI	Incidence of adverse effects of buprenorphine use on fetal and placental changes using MRI.	5 years
Secondary	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