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临床试验/NCT00882648
NCT00882648已完成不适用

The Effect of Fetal Gender on Maternal Substance Abuse Treatment

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 850 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
850
试验地点
1
主要终点
Compliance with substance abuse treatment group and individual sessions and ability to maintain abstinence from illicit drug use

研究概览

简要总结

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.

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • All CAP clients who depart CAP treatment prior to pregnancy loss or birth during that time period

结局指标

主要结局

Compliance with substance abuse treatment group and individual sessions and ability to maintain abstinence from illicit drug use

时间窗: 1.5 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lauren M. Jansson

Associate Professr of Pediatrics Johns Hopkins University School of Medicine

National Institute on Drug Abuse (NIDA)

研究点 (1)

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