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出境医 / 临床实验 / Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes (Mother/BabyOUD)
Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes (Mother/BabyOUD)
Study Description
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.
Study Design
| 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 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
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Pregnant Mothers with Opioid Use Disorder
Planned recruitment of 200 pregnant (<16weeks) mothers who have opioid use disorder and are taking buprenorphine
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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.
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Pregnant Mothers
Planned recruitment of 100 pregnant (>16weeks) mothers who do not have any history of opioid use disorder.
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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.
|
Outcome Measures
Primary Outcome Measures :
- 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.
- Pharmacological treatment for neonatal abstinence syndrome [ Time Frame: 5 years ]Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment.
Secondary Outcome Measures :
- 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.
- 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.
Eligibility Criteria
| 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.
Contacts and Locations
Contacts
| Contact: Senthil Sadhasivam, MD | 317-948-3845 | ssadhasivam@IUHealth.org |
Locations
| 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)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | October 24, 2018 | ||||
| First Posted Date | April 22, 2019 | ||||
| Last Update Posted Date | July 28, 2020 | ||||
| Actual Study Start Date | September 15, 2018 | ||||
| Estimated Primary Completion Date | June 30, 2023 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes | ||||
| Official Title | Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes | ||||
| 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). | ||||
| 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 [Patient Registry] | ||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
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| Target Follow-Up Duration | 2 Years | ||||
| Biospecimen | Retention: Samples With DNA Description:
Collection of DNA/Genetic/Epigenetic Samples from the mother at enrollment, then the infant at birth.
|
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| 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. | ||||
| Condition |
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| Intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
300 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | June 30, 2023 | ||||
| Estimated Primary Completion Date | June 30, 2023 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts |
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| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03923374 | ||||
| Other Study ID Numbers | 1807356299 1R01HD096800-01 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Senthilkumar Sadhasivam, MD, MPH, Indiana University | ||||
| Study Sponsor | Indiana University | ||||
| Collaborators |
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| Investigators | Not Provided | ||||
| PRS Account | Indiana University | ||||
| Verification Date | July 2020 | ||||
