Clinical trial NCT00882648: The Effect of Fetal Gender on Maternal Substance Abuse Treatment
Official title: The Effect of Fetal Gender on Maternal Substance Abuse Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Dependence
Pregnancy
Keywords: Drug dependence during pregnancy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-04-16
Enrollment: 850
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women enrolled in comprehensive substance abuse treatment at the Center for Addiction and Pregnancy (CAP) between 2004 and 2009

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.


Eligibility criteria: 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

Primary outcomes:
measure: Compliance with substance abuse treatment group and individual sessions and ability to maintain abstinence from illicit drug use
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Center for Addiction and Pregnancy
state: Maryland
Study officials:
References: