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NCT00882648 · ClinicalTrials.gov registry record
The Effect of Fetal Gender on Maternal Substance Abuse Treatment
A clinical trial of Pregnancy and Drug Dependence, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 850
- Enrollment target
- 1
- Study location
NCT00882648 is a study of Pregnancy and Drug Dependence that has completed, run by Johns Hopkins University. The registered enrollment target is 850 participants, roughly in line with the 868-participant average among 191 other Pregnancy trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT00882648, a study of Pregnancy and Drug Dependence, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 850 participants
- Enrollment target
- 1
- Study location
Study 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. psychotropi
Conditions Studied
Study Locations (1)
Maryland
- The Center for Addiction and Pregnancy - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 850 participants |
| Start Date | 2009-04 |
| Est. Completion | 2010-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00882648
The ClinicalTrials.gov registry entry for NCT00882648 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 850 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 868-participant average among 191 other Pregnancy trials with a reported enrollment target. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pregnancy appearing as the primary indexed condition, and to 0 interventions.
NCT00882648 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00882648 about?
NCT00882648 is a clinical study titled "The Effect of Fetal Gender on Maternal Substance Abuse Treatment". 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 expre...
What is the current status of trial NCT00882648?
This trial is currently completed. The enrollment target is 850 participants. The study started on 2009-04. Estimated completion is 2010-09.
What conditions does trial NCT00882648 study?
This clinical trial studies the following conditions: Pregnancy, Drug Dependence.
Who is sponsoring clinical trial NCT00882648?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00882648 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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