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

Neonatal Abstinence Syndrome Clinical Trial

— HOPE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01889121
• Other study ID #: HOPE_Methadone
• Status: Completed
• Phase: N/A
• First received: June 24, 2013
• Last updated: June 26, 2013
• Start date: February 2013
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: None
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Henry Akinbi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No