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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA041367-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this mechanistic study is to evaluate the effects that maternal buprenorphine-naloxone maintenance have on the neurobehavioral development of the fetus and infant. To accomplish this, the investigators will study a sample of 120 opioid dependent pregnant women that will receive buprenorphine-naloxone as part of substance abuse treatment at a comprehensive care treatment facility for pregnant and parenting women with substance use disorders. Fetal neurobehavior and maternal physiology will be assessed, via an established maternal-fetal data acquisition system, at 4 points during gestation: 24, 28, 32 and 36 weeks. Infant birth parameters and Neonatal Abstinence Syndrome (NAS) spectrum display will be evaluated at birth, and infant neurodevelopment will be assessed during the first month of life.
The project population will be 40 pregnant women with opioid use disorder inducted as outpatients to buprenorphine-naloxone maintenance. Subject treatment data, including medical and obstetric histories, drug use histories, demographic information and psychosocial information will be extracted from patient charts. Weekly urine toxicology testing will provide information regarding other substance use/misuse during the time of study participation. Study participants will undergo 2 60 minute maternal and fetal neurophysiologic monitoring sessions on one day at 4 points during gestation: 24, 28, 32 and 36 weeks, at times of trough (just before sublingual buprenorphine-naloxone or methadone daily dose) and peak (2 1/2 hours after dosing) maternal drug levels. Fetal cardiac (heart rate, heart rate variability, heart rate accelerations) and movement (total fetal movement, number and duration of movement bouts) and the correlation between the two (fetal heart rate-movement coupling) will be determined. Maternal physiologic measures will include heart period and variability, vagal tone, skin conductance and respiratory data. All maternal and fetal measures, with the exception of blood pressure, will be computed in 1-minute intervals and averaged over the 60 min recording. Infant birth data and birth parameters, and neonatal abstinence syndrome scores will be extracted from patient charts. Infants will undergo neurobehavioral testing using the Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale, a 30 minute harmless assessment of infant functioning, on days 3, 14 and 30 of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buprenorphine-naloxone treated | Experimental | Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fetal monitoring | Device | Maternal fetal monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fetal Heart Rate at 24 Weeks | Fetal heart rate in beats per minute, mean over 60 minutes gestation. Fetal heart rate in msec at 24 weeks of gestation at times of peak maternal plasma drug concentrations | 24 weeks of gestation |
| Fetal Heart Rate at 28 Weeks Gestation | Fetal heart rate in beats per minute, mean over 60 minutes gestation. Fetal heart rate at 28 weeks of gestation at times of tpeak maternal plasma drug concentrations. | 28 weeks of gestation |
| Fetal Heart Rate at 32 Weeks Gestation | Fetal heart rate in beats per minute, mean over 60 minutes. Fetal heart rate at 32 weeks of gestation at times of peak maternal plasma drug concentrations | 32 weeks of gestation |
| Fetal Heart Rate at 36 Weeks Gestation | Fetal heart rate in beats per minute, mean over 60 minutes. Fetal heart rate at 36 weeks of gestation at times of peak maternal plasma drug concentrations. | 36 weeks of gestation |
| Total Fetal Movement at 24 Weeks Gestation | Total fetal movement at 24 weeks of gestation. Total number of fetal moves over 60 minutes via fetal monitoring at time of peak maternal plasma drug concentrations at 24 weeks of gestation. | 24 weeks of gestation |
| Total Fetal Movement at 36 Weeks Gestation | Total fetal movement over 60 minutes via fetal monitoring at 36 weeks of gestation. Nimber of fetal movements over 60 minutes via fetal monitoring at times of peak maternal plasma drug concentrations at 36 weeks of gestation. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women with opioid use disorder
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| Name | Affiliation | Role |
|---|---|---|
| Lauren M Jansson, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Buprenorphine-naloxone Treated | Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy fetal monitoring: Maternal fetal monitoring Buprenorphine Naloxone: Treatment for opioid use disorder |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Data not collected for subjects removed from the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Buprenorphine-naloxone Treated | Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy fetal monitoring: Maternal fetal monitoring Buprenorphine Naloxone: Treatment for opioid use disorder |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fetal Heart Rate at 24 Weeks | Fetal heart rate in beats per minute, mean over 60 minutes gestation. Fetal heart rate in msec at 24 weeks of gestation at times of peak maternal plasma drug concentrations | Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring | Posted | Mean | Standard Deviation | beats per minute | 24 weeks of gestation | Fetuses | Fetuses |
|
From the time of protocol enrollment up to 30 days of infant age, an average of 6 months
Any adverse pregnancy or neonatal complication was reported. All pregnancies were tracked via the project obstetrician from the time of study enrollment until delivery. All infants were tracked from the time of delivery through 30 days of age.
There were 26 pregnancies during the study. Two women had two pregnancies each.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Buprenorphine-naloxone Treated | Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy fetal monitoring: Maternal fetal monitoring Buprenorphine Naloxone: Treatment for opioid use disorder |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pectus carinatum, mild | Musculoskeletal and connective tissue disorders | Systematic Assessment | Also low set ears. Determined to be morphologically similar to the father of the baby. |
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The COVID pandemic greatly affected the program from which participants were drawn and thereby subject enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Jansson | Johns Hopkins University School of Medicine | 4105504114 | ljansson@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2022 | Oct 17, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009357 | Neonatal Abstinence Syndrome |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D005323 | Fetal Monitoring |
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008991 | Monitoring, Physiologic |
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A group of n=40 study participants will receive buprenorphine-naloxone medication assisted therapy for the treatment of opioid use disorder during pregnancy. This group will undergo fetal monitoring at 24, 28, 32 and 36 weeks of gestation.
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| Buprenorphine Naloxone | Drug | Treatment for opioid use disorder |
|
|
| 36 weeks of gestation |
| Total Fetal Movement at 28 Weeks Gestation | Total fetal movement over 60 minutes via fetal monitoring. Total fetal movement over 60 minutes via fetal monitoring at times of trough and peak maternal plasma drug concentrations at 28 weeks of gestation. | 28 weeks of gestation |
| Total Fetal Movement at 32 Weeks Gestation | Total fetal movement over 60 minutes via fetal monitoring at 32 weeks of gestation. Number of fetal moves over 60 minutes via fetal monitoring at times of peak maternal plasma drug concentrations at 32 weeks of gestation. | 32 weeks of gestation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Fetuses |
|
|
| Primary | Fetal Heart Rate at 28 Weeks Gestation | Fetal heart rate in beats per minute, mean over 60 minutes gestation. Fetal heart rate at 28 weeks of gestation at times of tpeak maternal plasma drug concentrations. | Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring | Posted | Mean | Standard Deviation | beats per minute | 28 weeks of gestation | Fetuses | Fetuses |
|
|
|
| Primary | Fetal Heart Rate at 32 Weeks Gestation | Fetal heart rate in beats per minute, mean over 60 minutes. Fetal heart rate at 32 weeks of gestation at times of peak maternal plasma drug concentrations | Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring | Posted | Mean | Standard Deviation | beats per minute | 32 weeks of gestation | Fetuses | Fetuses |
|
|
|
| Primary | Fetal Heart Rate at 36 Weeks Gestation | Fetal heart rate in beats per minute, mean over 60 minutes. Fetal heart rate at 36 weeks of gestation at times of peak maternal plasma drug concentrations. | Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring | Posted | Mean | Standard Deviation | beats per minute | 36 weeks of gestation | Fetuses | Fetuses |
|
|
|
| Primary | Total Fetal Movement at 24 Weeks Gestation | Total fetal movement at 24 weeks of gestation. Total number of fetal moves over 60 minutes via fetal monitoring at time of peak maternal plasma drug concentrations at 24 weeks of gestation. | Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring | Posted | Mean | Standard Deviation | fetal movements | 24 weeks of gestation | Fetuses | Fetuses |
|
|
|
| Primary | Total Fetal Movement at 36 Weeks Gestation | Total fetal movement over 60 minutes via fetal monitoring at 36 weeks of gestation. Nimber of fetal movements over 60 minutes via fetal monitoring at times of peak maternal plasma drug concentrations at 36 weeks of gestation. | Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring | Posted | Mean | Standard Deviation | fetal movements | 36 weeks of gestation | Fetuses | Fetuses |
|
|
|
| Primary | Total Fetal Movement at 28 Weeks Gestation | Total fetal movement over 60 minutes via fetal monitoring. Total fetal movement over 60 minutes via fetal monitoring at times of trough and peak maternal plasma drug concentrations at 28 weeks of gestation. | Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring | Posted | Mean | Standard Deviation | fetal movements | 28 weeks of gestation | Fetuses | Fetuses |
|
|
|
| Primary | Total Fetal Movement at 32 Weeks Gestation | Total fetal movement over 60 minutes via fetal monitoring at 32 weeks of gestation. Number of fetal moves over 60 minutes via fetal monitoring at times of peak maternal plasma drug concentrations at 32 weeks of gestation. | Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring | Posted | Mean | Standard Deviation | fetal movements | 32 weeks of gestation | Fetuses | Fetuses |
|
|
|
| 0 |
| 26 |
| 3 |
| 26 |
| 0 |
| 26 |
|
| missed spontaneous abortion | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Subject was inducted onto study medication at 11 weeks of gestation; she miscarried at fetus sized 7 weeks 6 days 3 days later. It was determined that the subject was not viably pregnant at the time of study medication induction |
|
| congenital malformation | Gastrointestinal disorders | Systematic Assessment | Infant was born with mild CHARGE association (presumed); most likely unrelated to study medication |
|
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| D001523 | Mental Disorders |
| D002047 | Buprenorphine |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D009270 | Naloxone |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |