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Clinical Trials/NCT01889121
NCT01889121CompletedNot Applicable

Retrospective Analysis of the Utility Formal Psychosocial Support in Enhancing the Outcome of Pregnancies in Opiate-addicted Pregnant Women in Agonist Maintenance Programs

Dr. Henry Akinbi1 site in 1 country113 target enrollmentStarted: February 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
113
Locations
1
Primary Endpoint
Percentage of newborns in each group that required pharmacological treatment for neonatal abstinence syndrome

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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 Outcomes

  • 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.)

Investigators

Sponsor
Dr. Henry Akinbi
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Henry Akinbi

Associate Professor

Children's Hospital Medical Center, Cincinnati

Study Sites (1)

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