The Effect of Fetal Gender on Maternal Substance Abuse Treatment

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT00882648
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
850
1
17
49.9

Study Details

Study Description

Brief Summary

Previous studies by this team of investigators has determined that male infants are more likely to display more severe neonatal abstinence syndrome (NAS) as a result of maternal opioid use during pregnancy (Jansson, 2007)and there is appears to be a gender-related biologic vulnerability to NAS expression (Jansson, 2009, submitted). The proposed study explores the relationship between fetal gender and substance abuse treatment outcomes among a population of women in comprehensive substance abuse treatment to explore the possibility of a psychosocial vulnerability among drug exposed male fetuses as opposed to female fetuses. Women in substance abuse treatment are a group at high risk for current exposure to violence, usually at the hands of significant others, and having a history of sexual abuse as a child, usually resulting from contact with a male family member. Therefore, they often have difficult relationships with men. At the Center for Addiction and Pregnancy (CAP), a 2006 study revealed that among a group of 715 pregnant women, reports of the exposure to violence was very high. Their rates of lifetime abuse ranged from 72.7% for physical abuse to 44.5% for sexual abuse. Rates of abuse remained high during their current pregnancy, ranging from 20% for physical abuse to 7.1% for sexual abuse (Velez, 2006). The abuse was very often at the hands of partners or other male family member perpetrators. We hypothesize that women carrying male fetuses will be less likely to remain complaint in drug treatment or abstinent from illicit drug use, while women carrying female fetuses may be more likely to remain drug abstinent and treatment compliant. If supported, this theory has the potential to inform fetal gender specific treatment for pregnant drug dependent women. Additionally, we seek to support the previously documented link between male gender and more severe expression of NAS, and explore the relationship between other maternal prescribed drug use (i.e. psychotropic medications) and severity of NAS expression.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    850 participants
    Time Perspective:
    Retrospective
    Official Title:
    The Effect of Fetal Gender on Maternal Substance Abuse Treatment
    Study Start Date :
    Apr 1, 2009
    Actual Primary Completion Date :
    Sep 1, 2010
    Actual Study Completion Date :
    Sep 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Drug dependent women

    All drug dependent women enrolled in comprehensive substance abuse treatment at the Center for Addiction and Pregnancy of Johns Hopkins University between 2004 and 2009; retrospective chart review.

    Outcome Measures

    Primary Outcome Measures

    1. Compliance with substance abuse treatment group and individual sessions and ability to maintain abstinence from illicit drug use [1.5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All CAP clients who either experience a pregnancy loss, or deliver an infant while in treatment at CAP between the years 7/1/03 and 6/30/08
    Exclusion Criteria:
    • All CAP clients who depart CAP treatment prior to pregnancy loss or birth during that time period

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Center for Addiction and Pregnancy Baltimore Maryland United States 21224

    Sponsors and Collaborators

    • Johns Hopkins University
    • National Institute on Drug Abuse (NIDA)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lauren M. Jansson, Associate Professr of Pediatrics Johns Hopkins University School of Medicine, National Institute on Drug Abuse (NIDA)
    ClinicalTrials.gov Identifier:
    NCT00882648
    Other Study ID Numbers:
    • 19524
    • R01DA019934
    First Posted:
    Apr 16, 2009
    Last Update Posted:
    Feb 21, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Lauren M. Jansson, Associate Professr of Pediatrics Johns Hopkins University School of Medicine, National Institute on Drug Abuse (NIDA)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 21, 2013