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

NCT01889121 | Completed

• 1 other identifier: HOPE_Methadone
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Abstinence Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Gestational age at which the infants were delivered.

  Gestational age at delivery.

• Percentage of infants that are small for gestational age.

  Gestional period.

• Anthropometric measurements at birth

  Measurements at birth.

Study Arms (2)

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.

Psychosocial intervention

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

Behavioral: Structured psychosocial intervention

Interventions

Structured psychosocial intervention BEHAVIORAL

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

Psychosocial intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Positive Methadone tox screen
• Received care at Good Samaritan Hospital in Cincinnati
• Delivered at Good Samaritan Hospital

You may not qualify if:

• Twin gestation
• Sever congenital anomalies
• Conditions requiring transfer to quaternary hospital

Sponsors & Collaborators

• Dr. Henry Akinbi: lead

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: June 28, 2013
• Study Start: February 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 28, 2013

Record last verified: 2013-06

Locations

US (1)