The purpose of this study is to evaluate the effects of drugs used by treatment providers on the fetuses and infants of opiate dependent women. The subjects in this study are women enrolled in a large, multi-site, double blind study that looks at the effects of methadone and buprenorphine treatment during pregnancy. This study will evaluate fetal and maternal biophysiologic data longitudinally during pregnancy to determine how these substances may affect fetal neurobehavior. Additionally, infant neurobehavioral assessments and measurements of infant vagal tone will be collected to see how methadone and buprenorphine differentially affect the neonatal abstinence syndrome, or "withdrawal" in exposed neonates.
Primary Outcome Measures:
- Fetal heart rate [ Time Frame: up to 300 minutes ] [ Designated as safety issue: No ]
- Fetal movement [ Time Frame: up to 300 minutes ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Neonatal abstinence syndrome [ Time Frame: 4 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: |
60 |
| Study Start Date: |
September 2005 |
| Estimated Study Completion Date: |
August 2010 |
| Estimated Primary Completion Date: |
August 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
Procedure: Buprenorphine / methadone
Parallel study to double blind, double dummy study evaluating safety and efficacy of buprenorphine vs methadone treatment for pregnant opioid dependent women
Previous research by this group has found that methadone treatment during pregnancy directly impacts fetal neurophysiology independently of maternal physiology. Buprenorphine is a new therapy for opiate dependent individuals, and its use during pregnancy is currently being evaluated. Some research has shown that buprenorphine lessens the neonatal abstinence syndrome when compared to methadone. Thirty methadone and 30 buprenorphine maintained women will be evaluated at 24, 28, 32 and 36 weeks gestation using a state-of-the-art computerized fetal actocardiograph and data analysis program to simultaneously evaluate fetal movement and heart rate and maternal physiologic parameters. Investigators will be blinded to treatment group. Longitudinal neurodevelopment of the fetuses in each group will be explored. The differential effects of methadone and buprenorphine on the neonatal abstinence syndrome will also be explored.
Purpose
