Opioid-use DisorderMother/BabyOUDNCT03923374
Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
An observational study of Opioid-use Disorder and Opioid Use, Unspecified, run by Senthil Sadhasivam at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder, Opioid Use, Unspecified, Buprenorphine Dependence
- What is being tested?
- Subutex / Buprenorphine, Fetal & Neonatal MRI and DNA/Genetic/Pharmacokenetic Blood Draws
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2018to 30 Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Serious maternal medical illness as deemed by study physician or investigator.
- Known or suspected major fetal/neonatal congenital abnormalities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Children's Hospital
Pittsburgh, Pennsylvania, 15224
Senthil M Sadhasivam, MD, MPH, 4126474484, sadhasivams@upmc.edu
Carly Riedmann, MPH, 4126234147, riedmannca@upmc.edu
About this study
Official title: 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).
Read the 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.
- Being tested
- Subutex / Buprenorphine, Fetal & Neonatal MRI, DNA/Genetic/Pharmacokenetic Blood Draws
- Keywords
- Pregnant with Opioid Use Disorder, Opioid Use Disorder ( OUD), Subutex, Buprenorphine, Pregnant taking buprenorphine/subutex
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subutex / BuprenorphineDrug
Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.
Fetal & Neonatal MRIDiagnostic test
Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.
DNA/Genetic/Pharmacokenetic Blood DrawsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Mothers with Opioid Use Disorder | Planned recruitment of 200 pregnant (<16weeks) mothers who have opioid use disorder and are taking buprenorphine Receives: Drug: Subutex / Buprenorphine; Diagnostic Test: Fetal & Neonatal MRI; Diagnostic Test: DNA/Genetic/Pharmacokenetic Blood Draws | |
| Pregnant Mothers | Planned recruitment of 100 pregnant (>16weeks) mothers who do not have any history of opioid use disorder. Receives: Diagnostic Test: Fetal & Neonatal MRI; Diagnostic Test: DNA/Genetic/Pharmacokenetic Blood Draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Pharmacological treatment for neonatal abstinence syndrome
Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment.
Measured: 5 years
Secondary outcomes (2)
Incidence of adverse effects of buprenorphine using MRI
Incidence of adverse effects of buprenorphine use on fetal and placental changes using MRI.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start15 Sep 2018
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Senthil Sadhasivam
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Senthil Sadhasivam, University of Pittsburgh
- Investigators
- Senthil Sadhasivam, MD, MPH, Principal investigator, University of Pittsburgh, UPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923374
- Sponsor's protocol ID
- STUDY21110112
- Other IDs
- 1R01HD096800-01
- Acronym
- Mother/BabyOUD
- Status last verified
- Dec 2025
- First submitted
- 24 Oct 2018
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
- ClinicalTrials.gov ID
- NCT03923374
- Acronym / sponsor ID
- Mother/BabyOUD / STUDY21110112
- Keywords
- Pregnant with Opioid Use Disorder, Opioid Use Disorder ( OUD), Subutex, Buprenorphine, Pregnant taking buprenorphine/subutex
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Senthil SadhasivamUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA)
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Mothers with Opioid Use Disorder | – | Drug: Subutex / Buprenorphine, Diagnostic Test: Fetal & Neonatal MRI, Diagnostic Test: DNA/Genetic/Pharmacokenetic Blood DrawsPlanned recruitment of 200 pregnant (<16weeks) mothers who have opioid use disorder and are taking buprenorphine |
| Pregnant Mothers | – | Diagnostic Test: Fetal & Neonatal MRI, Diagnostic Test: DNA/Genetic/Pharmacokenetic Blood DrawsPlanned recruitment of 100 pregnant (>16weeks) mothers who do not have any history of opioid use disorder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Serious maternal medical illness as deemed by study physician or investigator.
- Known or suspected major fetal/neonatal congenital abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subutex / BuprenorphinePregnant Mothers must be taking buprenorphine / subutex for opioid use disorder. | Drug | Pregnant Mothers with Opioid Use Disorder |
| Fetal & Neonatal MRIMothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI. | Diagnostic test | Pregnant Mothers, Pregnant Mothers with Opioid Use Disorder |
| DNA/Genetic/Pharmacokenetic Blood DrawsThroughout 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. | Diagnostic test | Pregnant Mothers, Pregnant Mothers with Opioid Use Disorder |
Primary outcome
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.
2 secondary outcomes
Incidence of adverse effects of buprenorphine using MRI
Time frame: 5 years
Concentration of long-term neurodevelopmental outcomes using assessments
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Senthil Sadhasivam, MD, MPH principal investigator
University of Pittsburgh, UPMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-use Disorder and Opioid Use, Unspecified, run by Senthil Sadhasivam at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Senthil Sadhasivam, MD, MPH (4126474484, sadhasivams@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of opioid misuse severity using assessments (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.