VIBATIV Pregnancy Registry
- Registration Number
- NCT01130324
- Lead Sponsor
- Cumberland Pharmaceuticals
- Brief Summary
The purpose of this registry is to evaluate the outcome of pregnancy in women exposed to VIBATIV at any time during pregnancy. There are no mandated physician visits for the registry.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
- Female patients who were exposed to VIBATIV at any time during pregnancy
- Outcome of pregnancy is unknown at the time of enrollment
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description VIBATIV treated pregnant women VIBATIV Women treated with telavancin (any dose or duration) during pregnancy.
- Primary Outcome Measures
Name Time Method Outcomes of pregnancy in women exposed to VIBATIV at any time during pregnancy Once per trimester, 6-7 months gestation, and within 4 weeks after the estimated due date
- Secondary Outcome Measures
Name Time Method Effect of fetal exposure to VIBATIV on pregnancy outcomes Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age. Fetal/neonatal outcomes Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age. Infant development and milestones through 12 months of age Within 4 weeks after the estimated due date and if a live infant birth is reported, at 3, 6, 9, and 12 months of age.
Trial Locations
- Locations (1)
Cumberland Pharmaceuticals Inc.
🇺🇸Nashville, Tennessee, United States