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

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ClinicalTrials.gov Identifier: NCT03923374
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Senthilkumar Sadhasivam, MD, MPH, Indiana University

Brief 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).

Condition or disease Intervention/treatment
Opioid-use Disorder Opioid Use, Unspecified Buprenorphine Dependence 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
Actual Study Start Date : September 15, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Collection of DNA/Genetic/Epigenetic Samples from the mother at enrollment, then the infant at birth.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923374


Locations
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United States, Indiana
Riley Hospital for Children; Anesthesia Department Recruiting
Indianapolis, Indiana, United States, 46220
Contact: Christina M Sparks, MSW    317-944-9739    sparkscm@iupui.edu   
Principal Investigator: Senthilkumar Sadhasivam, M.D.         
Sponsors and Collaborators
Indiana University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)

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Responsible Party: Senthilkumar Sadhasivam, MD, MPH, Principal Investigator, Indiana University
ClinicalTrials.gov Identifier: NCT03923374     History of Changes
Other Study ID Numbers: 1807356299
1R01HD096800-01 ( U.S. NIH Grant/Contract )
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Senthilkumar Sadhasivam, MD, MPH, Indiana University:
Pregnant with Opioid Use Disorder
Opioid Use Disorder ( OUD)
Subutex
Buprenorphine
Pregnant taking buprenorphine/subutex
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Buprenorphine
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists