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Completed

NCT Number: NCT01889121

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

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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Observational

Primary location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dr. Henry Akinbi

Other

Registry information

Official study title

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

Acronym: HOPE

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 28, 2013
Registry last updated
Jun 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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