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Twinrix Pregnancy Registry

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ClinicalTrials.gov Identifier: NCT03619590
Recruitment Status : Completed
First Posted : August 8, 2018
Results First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hepatitis
Intervention Other: Data Collection
Enrollment 245
Recruitment Details Study population included pregnant women who prospectively reported exposure to Twinrix within 28 days prior to conception or at any time during pregnancy. 245 pregnancies were prospectively registered in the study. 142 pregnancies were lost to follow-up. Outcomes were reported for 103 pregnancies. Hence, the number of subjects started is 103.
Pre-assignment Details A total of 105 outcomes were reported for 103 pregnancies due to 2 sets of twins, one each from pregnancies with reported exposure during the first trimester and an unspecified trimester, respectively.
Arm/Group Title Exposure Group
Hide Arm/Group Description Pregnant women who were exposed to Twinrix within 28 days prior to conception or at any time during pregnancy. Reporting of exposed pregnancies was voluntary and prospective.
Period Title: Overall Study
Started 103
Completed 103
Not Completed 0
Arm/Group Title Exposure Group
Hide Arm/Group Description Pregnant women who were exposed to Twinrix within 28 days prior to conception or at any time during pregnancy. Reporting of exposed pregnancies was voluntary and prospective.
Overall Number of Baseline Participants 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
≤ 18 years Number Analyzed 103 participants
1
   1.0%
> 18 and < 65 years Number Analyzed 103 participants
94
  91.3%
≥ 65 years Number Analyzed 103 participants
0
   0.0%
Age not specified Number Analyzed 103 participants
8
   7.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants
Female
103
 100.0%
Male
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Number of Outcomes From Pregnancies With Reported Exposure Within 28 Days of Last Menstrual Period
Hide Description

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.

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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the outcomes reported for the pregnancies with exposure to Twinrix within 28 days prior to conception or at any time during pregnancy. A total of 105 outcomes were reported for 103 pregnancies due to 2 sets of twins, one each from pregnancies with reported exposure during the first trimester and an unspecified trimester.
Arm/Group Title Exposure Group
Hide Arm/Group Description:
Pregnant women who were exposed to Twinrix within 28 days prior to conception or at any time during pregnancy. Reporting of exposed pregnancies was voluntary and prospective.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Pregnancy Outcomes
Congenital Abnormalities, Live Birth 0
Congenital Abnormalities, Spontaneous Abortion 0
Congenital Abnormalities, Fetal Death 0
Congenital Abnormalities, Induced Abortion 0
No Congenital Abnormalities, Live Birth 4
No Congenital Abnormalities, Spontaneous Abortion 1
No Congenital Abnormalities, Fetal Death 1
No Congenital Abnormalities, Induced Abortion 0
2.Primary Outcome
Title Number of Outcomes From Pregnancies With Earliest Reported Exposure During the First Trimester
Hide Description

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.

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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the outcomes reported for the pregnancies with exposure to Twinrix within 28 days prior to conception or at any time during pregnancy. A total of 105 outcomes were reported for 103 pregnancies due to 2 sets of twins, one each from pregnancies with reported exposure during the first trimester and an unspecified trimester.
Arm/Group Title Exposure Group
Hide Arm/Group Description:
Pregnant women who were exposed to Twinrix within 28 days prior to conception or at any time during pregnancy. Reporting of exposed pregnancies was voluntary and prospective.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Pregnancy Outcomes
Congenital Abnormalities, Live Birth 3
Congenital Abnormalities, Spontaneous Abortion 0
Congenital Abnormalities, Fetal Death 0
Congenital Abnormalities, Induced Abortion 1
No Congenital Abnormalities, Live Birth 60
No Congenital Abnormalities, Spontaneous Abortion 7
No Congenital Abnormalities, Fetal Death 0
No Congenital Abnormalities, Induced Abortion 5
3.Primary Outcome
Title Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Second Trimester
Hide Description

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.

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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the outcomes reported for the pregnancies with exposure to Twinrix within 28 days prior to conception or at any time during pregnancy. A total of 105 outcomes were reported for 103 pregnancies due to 2 sets of twins, one each from pregnancies with reported exposure during the first trimester and an unspecified trimester.
Arm/Group Title Exposure Group
Hide Arm/Group Description:
Pregnant women who were exposed to Twinrix within 28 days prior to conception or at any time during pregnancy. Reporting of exposed pregnancies was voluntary and prospective.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Pregnancy Outcomes
Congenital Abnormalities, Live Birth 2
Congenital Abnormalities, Spontaneous Abortion 0
Congenital Abnormalities, Fetal Death 0
Congenital Abnormalities, Induced Abortion 0
No Congenital Abnormalities, Live Birth 11
No Congenital Abnormalities, Spontaneous Abortion 0
No Congenital Abnormalities, Fetal Death 0
No Congenital Abnormalities, Induced Abortion 0
4.Primary Outcome
Title Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Third Trimester
Hide Description

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.

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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the outcomes reported for the pregnancies with exposure to Twinrix within 28 days prior to conception or at any time during pregnancy. A total of 105 outcomes were reported for 103 pregnancies due to 2 sets of twins, one each from pregnancies with reported exposure during the first trimester and an unspecified trimester.
Arm/Group Title Exposure Group
Hide Arm/Group Description:
Pregnant women who were exposed to Twinrix within 28 days prior to conception or at any time during pregnancy. Reporting of exposed pregnancies was voluntary and prospective.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Pregnancy Outcomes
Congenital Abnormalities, Live Birth 0
Congenital Abnormalities, Spontaneous Abortion 0
Congenital Abnormalities, Fetal Death 0
Congenital Abnormalities, Induced Abortion 0
No Congenital Abnormalities, Live Birth 1
No Congenital Abnormalities, Spontaneous Abortion 0
No Congenital Abnormalities, Fetal Death 0
No Congenital Abnormalities, Induced Abortion 0
5.Primary Outcome
Title Number of Outcomes From Pregnancies With Reported Exposure During an Unspecified Trimester
Hide Description

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.

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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the outcomes reported for the pregnancies with exposure to Twinrix within 28 days prior to conception or at any time during pregnancy. A total of 105 outcomes were reported for 103 pregnancies due to 2 sets of twins, one each from pregnancies with reported exposure during the first trimester and an unspecified trimester.
Arm/Group Title Exposure Group
Hide Arm/Group Description:
Pregnant women who were exposed to Twinrix within 28 days prior to conception or at any time during pregnancy. Reporting of exposed pregnancies was voluntary and prospective.
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: Pregnancy Outcomes
Congenital Abnormalities, Live Birth 0
Congenital Abnormalities, Spontaneous Abortion 0
Congenital Abnormalities, Fetal Death 0
Congenital Abnormalities, Induced Abortion 0
No Congenital Abnormalities, Live Birth 7
No Congenital Abnormalities, Spontaneous Abortion 2
No Congenital Abnormalities, Fetal Death 0
No Congenital Abnormalities, Induced Abortion 0
Time Frame [Not Specified]
Adverse Event Reporting Description No safety data was collected in the study.
 
Arm/Group Title Exposure Group
Hide Arm/Group Description Pregnant women who were exposed to Twinrix within 28 days prior to conception or at any time during pregnancy. Reporting of exposed pregnancies was voluntary and prospective.
All-Cause Mortality
Exposure Group
Affected / at Risk (%)
Total   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Exposure Group
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Exposure Group
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03619590     History of Changes
Other Study ID Numbers: 201339
First Submitted: July 18, 2018
First Posted: August 8, 2018
Results First Submitted: September 7, 2018
Results First Posted: February 4, 2019
Last Update Posted: February 4, 2019