Utility of Psychosocial Intervention in Improving Outcome for Methadone-exposed Infants and Their Mothers

Study Overview
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Brief Summary
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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.

Official Title
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Retrospective Analysis of the Utility Formal Psychosocial Support in Enhancing the Outcome of Pregnancies in Opiate-addicted Pregnant Women in Agonist Maintenance Programs

Conditions
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Neonatal Abstinence Syndrome

Intervention / Treatment
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* Behavioral: Structured psychosocial intervention


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Methadone maintenance program<br>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. | |
| Psychosocial intervention<br>Pregnant women who were in methadone maintenance program PLUS structured psychosocial intervention at the time of delivery (HOPE Program). | Behavioral: Structured psychosocial intervention<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of newborns in each group that required pharmacological treatment for neonatal abstinence syndrome | 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. | Birth until discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age at which the infants were delivered. | 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. | Gestational age at delivery. | 
| Percentage of infants that are small for gestational age. | 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. | Gestional period. | 
| Anthropometric measurements at birth | Differences between the mean birth weight, Length and head circumference at birth were compared between the two groups. | Measurements at birth. |