N/A
Completed N=103
Twinrix Pregnancy Registry
Source: ClinicalTrials.gov NCT03619590 ↗Enrolled (actual)
103
Serious AEs
—
Results posted
Feb 2019
Primary outcomePrimary: Number of Outcomes From Pregnancies With Reported Exposure Within 28 Days of Last Menstrual Period — 0; 0; 0; 0 Pregnancy Outcomes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Outcomes From Pregnancies With Reported Exposure Within 28 Days of Last Menstrual Period |
0; 0; 0; 0; 4; 1 | — |
| PRIMARY Number of Outcomes From Pregnancies With Earliest Reported Exposure During the First Trimester |
3; 0; 0; 1; 60; 7 | — |
| PRIMARY Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Second Trimester |
2; 0; 0; 0; 11; 0 | — |
| PRIMARY Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Third Trimester |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Outcomes From Pregnancies With Reported Exposure During an Unspecified Trimester |
0; 0; 0; 0; 7; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Documentation that Twinrix was administered ≤ 28 days before or during pregnancy;
- Confirmation that the pregnancy is being prospectively reported;
- Report made by a patient or a health care professional;
- The timing of the prenatal exposure to Twinrix (no broader than during which trimester);
- A patient identifier that will allow follow-up to be obtained so that the pregnancy outcome can be ascertained;
- Whether the patient was involved in a clinical trial at the time of the exposure;
- Full reporter contact information.
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT03619590). 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.