The Effect of Fetal Gender on Maternal Substance Abuse Treatment

Pregnancy Clinical Trial

Official title:

The Effect of Fetal Gender on Maternal Substance Abuse Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882648
• Other study ID #: 19524
• Secondary ID: R01DA019934
• Status: Completed
• Phase: N/A
• First received: April 15, 2009
• Last updated: February 19, 2013
• Start date: April 2009
• Est. completion date: September 2010

Study information

• Verified date: February 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Drug Dependence
• Pregnancy

Locations

Country	Name	City	State
United States	The Center for Addiction and Pregnancy	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance with substance abuse treatment group and individual sessions and ability to maintain abstinence from illicit drug use		1.5 years	No