Twinrix Pregnancy Registry

NCT03619590 | Completed Results FDA Drug

• 1 other identifier: 201339
• Study Type: observational
• Target: 245
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatitis

Keywords

Teratogenicity; Pregnancy; Hepatitis B; Twinrix; Prenatal exposure; Hepatitis A

Outcome Measures

Primary Outcomes (5)

• Number of Outcomes From Pregnancies With Reported Exposure Within 28 Days of Last Menstrual Period

  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

  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

  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

  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

  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)

Study Arms (1)

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.

Other: Data Collection

Interventions

Data Collection OTHER

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.

Exposure Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes pregnant women who were exposed to Twinrix within 28 days prior to conception or at any time during pregnancy.

You may qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Hepatitis; Teratogenesis; Hepatitis B; Hepatitis A

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

sk994601@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 8, 2018
• Study Start: May 18, 2001
• Primary Completion: September 15, 2017
• Study Completion: September 15, 2017
• Last Updated: February 4, 2019
• Results First Posted: February 4, 2019

Record last verified: 2018-08