At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Twinrix [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine] Pregnancy Registry
In Brief
An observational study evaluating Data Collection for Hepatitis. Completed, enrolled 245 participants.
Detailed Summary
The purpose of the Twinrix Pregnancy Registry is to prospectively collect data describing exposure to Twinrix before or during pregnancy, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy. This is a prospective, voluntary, observational, exposure-registration study. Twinrix is designated as Food and Drug Administration (FDA) Pregnancy Category C, which means that its safety in human pregnancy has not been determined. The Registry is intended to provide an early signal of potential risks in advance of results from formal epidemiologic studies. Registry statistics can supplement animal reproductive toxicology studies and assist clinicians in evaluating the potential risks and benefits of vaccination for individual patients.
Study Details
Timeline
Interventions
When the pregnancy is reported prospectively, the Registry will collect registration data from the reporter through telephone interview or a short registration form. In the month of the estimated date of delivery, follow-up will be sought by telephone contact or a form mailed to the health professional. Information about maternal events throughout the pregnancy, pregnancy outcome, and neonatal health is requested. Additional follow-up is not sought from subsequent health care providers.