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

Completed

• Conditions: Neonatal Abstinence Syndrome
• Interventions: Behavioral: Structured psychosocial intervention

• Registration Number: NCT01889121
• Lead Sponsor: Dr. Henry Akinbi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-06
• Study First Submitted: 2013-06-24
• Study First Submitted QC: 2013-06-26
• Last Update Submitted: 2013-06-26
• Study First Posted: 2013-06-28
• Last Update Posted: 2013-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 113

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Psychosocial intervention	Structured psychosocial intervention	Pregnant women who were in methadone maintenance program PLUS structured psychosocial intervention at the time of delivery (HOPE Program).

Primary Outcome Measures

Name	Time	Method
Percentage of newborns in each group that required pharmacological treatment for neonatal abstinence syndrome	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.

Secondary Outcome Measures

Name	Time	Method
Gestational age at which the infants were delivered.	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.	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	Measurements at birth.	Differences between the mean birth weight, Length and head circumference at birth were compared between the two groups.

Trial Locations

Locations (1)

Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States