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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Henry Akinbi, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01889121
First received: June 24, 2013
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Neonatal Abstinence Syndrome
Behavioral: Structured psychosocial intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Percentage of newborns in each group that required pharmacological treatment for neonatal abstinence syndrome [ Time Frame: Birth until discharge ] [ Designated as safety issue: No ]
    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:
  • Gestational age at which the infants were delivered. [ Time Frame: Gestational age at delivery. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Differences between the mean birth weight, Length and head circumference at birth were compared between the two groups.


Enrollment: 113
Study Start Date: February 2013
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01889121

Locations
United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
Dr. Henry Akinbi
  More Information

No publications provided

Responsible Party: Dr. Henry Akinbi, Associate Professor, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01889121     History of Changes
Other Study ID Numbers: HOPE_Methadone
Study First Received: June 24, 2013
Last Updated: June 26, 2013
Health Authority: United States: None

Additional relevant MeSH terms:
Neonatal Abstinence Syndrome
Infant, Newborn, Diseases
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Methadone
Analgesics
Analgesics, Opioid
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014