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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01889121

Acronym

HOPE

Enrollment

113

Registered

2013-06-28

Start date

2013-02-28

Completion date

2013-05-31

Last updated

2013-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Abstinence Syndrome

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.

Interventions

BEHAVIORALStructured 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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of newborns in each group that required pharmacological treatment for neonatal abstinence syndrome	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

Measure	Time frame	Description
Gestational age at which the infants were delivered.	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.
Percentage of infants that are small for gestational age.	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.
Anthropometric measurements at birth	Measurements at birth.	Differences between the mean birth weight, Length and head circumference at birth were compared between the two groups.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026