Phase 3
Completed N=127
Fetal and Infant Effects of Maternal Buprenorphine Treatment
Source: ClinicalTrials.gov NCT01561079 ↗Enrolled (actual)
127
Serious AEs
2.0%
Results posted
Aug 2017
Primary outcomePrimary: Fetal Heart Rate — 145.7; 143.3; 138.6; 136.3 beats per minute — p=0.001
◆ Published Evidence
Established
39citations · ~5 / year
Prenatal buprenorphine exposure and neonatal neurobehavioral functioning.
Summary
This research will track the longitudinal neurobehavioral development of the buprenorphine-exposed fetus across gestation through 1 month of age in an effort to determine the safety of this medication for use during gestation, the relationship between maternal physiologic changes due to buprenorphine administration and newborn functioning, and to determine potential fetal neurobehavioral markers that may predict Neonatal Abstinence Syndrome expression and infant neurobehavioral outcome. Comparisons to results from a similar project in methadone-exposed pregnancies will be made. This proposal seeks to advance the way the investigators inform the treatment of the opioid dependent woman during pregnancy and her infant after birth.
Linked Publications
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Prenatal buprenorphine exposure and neonatal neurobehavioral functioning.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fetal Heart Rate |
145.7; 143.3; 138.6; 136.3; 143.9; 141.0 | 0.001 sig |
| PRIMARY Fetal Heart Rate Variability |
5.4; 6.7; 7.5; 7.9; 4.9; 7.3 | <.002 sig |
| PRIMARY Accelerations of Fetal Heart Rate |
0.52; 1.59; 3.57; 5.28; 0.43; 2.12 | 0.0001 sig |
| PRIMARY Fetal Movement |
1496.2; 1390.0; 1458.7; 1446.7; 1613.0; 1385.7 | .008 sig |
| PRIMARY Fetal Movement - Fetal Heart Rate Coupling |
0.13; 0.21; 0.23; 0.25; 0.09; 0.20 | .002 sig |
Eligibility Criteria
Inclusion Criteria
- Current opioid dependence as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM) IV-R criteria
- 18-40 years of age with uncomplicated singleton pregnancies
- Accurate gestational age dating verified by ultrasound
- Gestation of less than 34 weeks
- Stabilization on buprenorphine for one week prior to study procedures
Exclusion Criteria
- Complications of pregnancy, including gestational diabetes, polyhydramnios, hypertension, placenta previa or significant risk of preterm delivery (i.e. incompetent cervix)
- Evidence of fetal malformation detected by prenatal ultrasound
- Significant general maternal health problems that can affect fetal functioning, including Type I or gestational diabetes, alterations in thyroid functioning, HIV infection or hypertension.
- Significant maternal psychopathology that would preclude informed consent (i.e. schizophrenia)
- Alcohol dependency per DSM IV R criteria (see ascertainment methods below)
- Women stable on methadone maintenance (defined as more than 3 days of methadone dosing)
- Women entering drug treatment reporting using "street" methadone (for more than 3 days)
Data sourced from ClinicalTrials.gov (NCT01561079) and the linked publication. 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. Informational only — not medical advice.