- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01889121
Utility of Psychosocial Intervention in Improving Outcome for Methadone-exposed Infants and Their Mothers (HOPE)
June 26, 2013 updated by: Dr. Henry Akinbi
Retrospective Analysis of the Utility Formal Psychosocial Support in Enhancing the Outcome of Pregnancies in Opiate-addicted Pregnant Women in Agonist Maintenance Programs
Opiate drug abuse/addiction is a significant co-morbidity in pregnancy.
Opiate maintenance program enhances the outcome of pregnancies for the mother and the infant.
Our objective was to assess if provision of structured psychosocial support in addition to methadone maintenance program adds incremental benefits with regards to the outcome of pregnancy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
113
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45220
- Good Samaritan Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Opiate abusing pregnant women who received their prenatal care through Good Samaritan Faculty Medical Center and were getting methadone maintenance therapy
Description
Inclusion Criteria:
- Positive Methadone tox screen
- Received care at Good Samaritan Hospital in Cincinnati
- Delivered at Good Samaritan Hospital
Exclusion Criteria:
- Twin gestation
- Sever congenital anomalies
- Conditions requiring transfer to quaternary hospital
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Methadone maintenance program
Mothers on methadone treatment at time of delivery who delivered at Good Samaritan Hospital but were not enrolled in psychosocial intervention offered through the HOPE (Helping Opiate-addicted Pregnant women Evolve) program.
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Psychosocial intervention
Pregnant women who were in methadone maintenance program PLUS structured psychosocial intervention at the time of delivery (HOPE Program).
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This is retrospective analysis of two groups of opiate-addicted pregnant women: 1) Pregnant women in methadone maintenance program 2) Pregnant women in methadone maintenance program AND structured psychosocial intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of newborns in each group that required pharmacological treatment for neonatal abstinence syndrome
Time Frame: Birth until discharge
|
Infants delivered to mothers that are maintained on methadone are at risk for neonatal abstinence syndrome.
Psychosocial support is provided to pregnant women in methadone maintenance program to impact the outcome of the infants.
The percentage of infants requiring pharmacotherapy would be expected to be reduced by the addition of psychosocial intervention to methadone maintenance program.
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Birth until discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gestational age at which the infants were delivered.
Time Frame: Gestational age at delivery.
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Addiction of pregnant women to opiate drugs is associated with preterm delivery.
The gestational ages of infants delivered to women in the two groups will be compared for statistically significant differences.
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Gestational age at delivery.
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Percentage of infants that are small for gestational age.
Time Frame: Gestional period.
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Addiction to opiates is associated with fetal growth restriction.
This study compared the proportion of infants who are <90th percentile for gestational age in both groups.
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Gestional period.
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Anthropometric measurements at birth
Time Frame: Measurements at birth.
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Differences between the mean birth weight, Length and head circumference at birth were compared between the two groups.
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Measurements at birth.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
June 24, 2013
First Submitted That Met QC Criteria
June 26, 2013
First Posted (Estimate)
June 28, 2013
Study Record Updates
Last Update Posted (Estimate)
June 28, 2013
Last Update Submitted That Met QC Criteria
June 26, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOPE_Methadone
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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