- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03619590
Twinrix Pregnancy Registry
Twinrix [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine] Pregnancy Registry
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 Overview
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Exposure Group
Pregnant women who were exposed to Twinrix within 28 days prior to conception or at any time during pregnancy.
Reporting of exposed pregnancies is voluntary and prospective.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Outcomes From Pregnancies With Reported Exposure Within 28 Days of Last Menstrual Period
Time Frame: From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)
|
Participants were followed from registration upon exposure to Twinrix within 28 days prior to conception until data on pregnancy outcome was obtained. Follow-up via telephone or a form mailed to the contact was sought in the month of the estimated date of delivery. Pregnancy outcomes were stratified by the trimester of exposure, with an additional stratum for preconception exposure with no subsequent administration during pregnancy; multiple exposures were classified by the earliest trimester of exposure. Gestational weeks were counted from the date of the last menstrual period. The second trimester was considered to begin at week 14, and the third trimester beginning at week 28. Pregnancy outcomes were dichotomized according to the presence or absence of birth defects and further categorized as: Live births, Spontaneous abortions (i.e., pregnancy losses), Induced abortions and Fetal deaths. |
From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the First Trimester
Time Frame: From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)
|
Participants were followed from registration upon exposure to Twinrix during first trimester of pregnancy until data on pregnancy outcome was obtained. Follow-up via telephone or a form mailed to the contact was sought in the month of the estimated date of delivery. Pregnancy outcomes were stratified by the trimester of exposure, with an additional stratum for preconception exposure with no subsequent administration during pregnancy; multiple exposures were classified by the earliest trimester of exposure. Gestational weeks were counted from the date of the last menstrual period. The second trimester was considered to begin at week 14, and the third trimester beginning at week 28. Pregnancy outcomes were dichotomized according to the presence or absence of birth defects and further categorized as: Live births, Spontaneous abortions (i.e., pregnancy losses), Induced abortions and Fetal deaths. |
From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Second Trimester
Time Frame: From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)
|
Participants were followed from registration upon exposure to Twinrix during second trimester of pregnancy until data on pregnancy outcome was obtained. Follow-up via telephone or a form mailed to the contact was sought in the month of the estimated date of delivery. Pregnancy outcomes were stratified by the trimester of exposure, with an additional stratum for preconception exposure with no subsequent administration during pregnancy; multiple exposures were classified by the earliest trimester of exposure. Gestational weeks were counted from the date of the last menstrual period. The second trimester was considered to begin at week 14, and the third trimester beginning at week 28. Pregnancy outcomes were dichotomized according to the presence or absence of birth defects and further categorized as: Live births, Spontaneous abortions (i.e., pregnancy losses), Induced abortions and Fetal deaths. |
From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Third Trimester
Time Frame: From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)
|
Participants were followed from registration upon exposure to Twinrix during third trimester of pregnancy until data on pregnancy outcome was obtained. Follow-up via telephone or a form mailed to the contact was sought in the month of the estimated date of delivery. Pregnancy outcomes were stratified by the trimester of exposure, with an additional stratum for preconception exposure with no subsequent administration during pregnancy; multiple exposures were classified by the earliest trimester of exposure. Gestational weeks were counted from the date of the last menstrual period. The second trimester was considered to begin at week 14, and the third trimester beginning at week 28. Pregnancy outcomes were dichotomized according to the presence or absence of birth defects and further categorized as: Live births, Spontaneous abortions (i.e., pregnancy losses), Induced abortions and Fetal deaths. |
From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)
|
Number of Outcomes From Pregnancies With Reported Exposure During an Unspecified Trimester
Time Frame: From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)
|
Participants were followed from registration upon exposure to Twinrix during unspecified trimester of pregnancy until data on pregnancy outcome was obtained. Follow-up via telephone or a form mailed to the contact was sought in the month of the estimated date of delivery. Pregnancy outcomes were stratified by the trimester of exposure, with an additional stratum for preconception exposure with no subsequent administration during pregnancy; multiple exposures were classified by the earliest trimester of exposure. Gestational weeks were counted from the date of the last menstrual period. The second trimester was considered to begin at week 14, and the third trimester beginning at week 28. Pregnancy outcomes were dichotomized according to the presence or absence of birth defects and further categorized as: Live births, Spontaneous abortions (i.e., pregnancy losses), Induced abortions and Fetal deaths. |
From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201339
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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