Utility of Psychosocial Intervention in Improving Outcome for Methadone-exposed Infants and Their Mothers (HOPE)
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|ClinicalTrials.gov Identifier: NCT01889121|
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
|Condition or disease||Intervention/treatment|
|Neonatal Abstinence Syndrome||Behavioral: Structured psychosocial intervention|
|Study Type :||Observational|
|Actual Enrollment :||113 participants|
|Official Title:||Retrospective Analysis of the Utility Formal Psychosocial Support in Enhancing the Outcome of Pregnancies in Opiate-addicted Pregnant Women in Agonist Maintenance Programs|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
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.
Pregnant women who were in methadone maintenance program PLUS structured psychosocial intervention at the time of delivery (HOPE Program).
Behavioral: Structured psychosocial intervention
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
- 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.
- Gestational age at which the infants were delivered. [ Time Frame: Gestational age at delivery. ]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.
- Percentage of infants that are small for gestational age. [ Time Frame: Gestional period. ]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.
- Anthropometric measurements at birth [ Time Frame: Measurements at birth. ]Differences between the mean birth weight, Length and head circumference at birth were compared between the two groups.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889121
|United States, Ohio|
|Good Samaritan Hospital|
|Cincinnati, Ohio, United States, 45220|