N/A
N=19
Fetal Neurobehavior in Non-methadone Maintained Women in Substance Abuse Treatment
Pregnancy · Drug Abuse
Bottom Line
View on ClinicalTrials.gov: NCT00522626 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Fetal Heart Rate — 142.34 beats per minute
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Maternal fetal monitoring (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Johns Hopkins University
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fetal Heart Rate |
142.34 | — |
| SECONDARY Maternal Physiologic Parameters |
— | — |
Summary
This study seeks to elucidate fetal neurobehavioral development in fetuses of opioid dependent women who have either undergone and completed methadone detoxification,or who never received methadone maintenance, and are not methadone maintained at 36 weeks gestation. This research will determine how fetal neurobehavioral functioning in fetuses of opioid dependent, non-methadone maintained women differs from that of fetuses whose opioid dependent mothers are methadone maintained. The project will utilize a state-of-the-art computerized fetal actocardiograph and data analysis program to simultaneously evaluate fetal movement and heart rate, the interaction between the two and maternal physiologic parameters.
Eligibility Criteria
Inclusion Criteria
- Generally healthy women between ages 18 and 40, current clients of the CAP program
- Singleton, uncomplicated pregnancies, dated with routine 16 to 20 week ultrasound (as is part of standard care at CAP)
- Abstinence from licit and illicit substance abuse in the four weeks prior to consent
Exclusion Criteria
- Complications of pregnancy, including gestational diabetes, polyhydramnios, hypertension, placenta previa or preterm labor
- Significant maternal health problems related to pregnancy, including HIV infection and Type I diabetes
- Significant maternal psychopathology or other pathology that would preclude informed consent (schizophrenia, mental retardation)
- Recent drug use, defined as positive urine toxicology (performed randomly at least weekly in the treatment center), clinical positives (subject appearing intoxicated at the treatment center) or patient report in the four weeks prior to recruitment, or at any time during study participation (i.e. from 28 weeks to 36 weeks gestation)
- Recent alcohol use, by clinical detection, patient report or breathalyzer reading (performed at the treatment center to confirm clinical impression) at any time in the four weeks prior to recruitment, or at any time during study participation
Data sourced from ClinicalTrials.gov (NCT00522626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.