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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01889121
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
Information provided by (Responsible Party):
Dr. Henry Akinbi, Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment
Neonatal Abstinence Syndrome Behavioral: Structured psychosocial intervention

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Study Type : Observational
Actual Enrollment : 113 participants
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
Study Start Date : February 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Methadone

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Percentage of newborns in each group that required pharmacological treatment for neonatal abstinence syndrome [ Time Frame: 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 :
  1. Gestational age at which the infants were delivered. [ Time Frame: 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.

  2. Percentage of infants that are small for gestational age. [ Time Frame: 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.

  3. Anthropometric measurements at birth [ Time Frame: Measurements at birth. ]
    Differences between the mean birth weight, Length and head circumference at birth were compared between the two groups.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01889121

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United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
Dr. Henry Akinbi
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Responsible Party: Dr. Henry Akinbi, Associate Professor, Children's Hospital Medical Center, Cincinnati Identifier: NCT01889121    
Other Study ID Numbers: HOPE_Methadone
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Neonatal Abstinence Syndrome
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders