Trial Outcomes & Findings for Twinrix Pregnancy Registry (NCT NCT03619590)
NCT ID: NCT03619590
Last Updated: 2019-02-04
Results Overview
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.
COMPLETED
245 participants
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)
2019-02-04
Participant Flow
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.
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.
Participant milestones
| Measure |
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 was voluntary and prospective.
|
|---|---|
|
Overall Study
STARTED
|
103
|
|
Overall Study
COMPLETED
|
103
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Exposure Group
n=103 Participants
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.
|
|---|---|
|
Age, Customized
≤ 18 years
|
1 Participants
n=103 Participants
|
|
Age, Customized
> 18 and < 65 years
|
94 Participants
n=103 Participants
|
|
Age, Customized
≥ 65 years
|
0 Participants
n=103 Participants
|
|
Age, Customized
Age not specified
|
8 Participants
n=103 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=103 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=103 Participants
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Exposure Group
n=103 Participants
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.
|
|---|---|
|
Number of Outcomes From Pregnancies With Reported Exposure Within 28 Days of Last Menstrual Period
Congenital Abnormalities, Live Birth
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Reported Exposure Within 28 Days of Last Menstrual Period
Congenital Abnormalities, Spontaneous Abortion
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Reported Exposure Within 28 Days of Last Menstrual Period
Congenital Abnormalities, Fetal Death
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Reported Exposure Within 28 Days of Last Menstrual Period
Congenital Abnormalities, Induced Abortion
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Reported Exposure Within 28 Days of Last Menstrual Period
No Congenital Abnormalities, Live Birth
|
4 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Reported Exposure Within 28 Days of Last Menstrual Period
No Congenital Abnormalities, Spontaneous Abortion
|
1 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Reported Exposure Within 28 Days of Last Menstrual Period
No Congenital Abnormalities, Fetal Death
|
1 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Reported Exposure Within 28 Days of Last Menstrual Period
No Congenital Abnormalities, Induced Abortion
|
0 Pregnancy Outcomes
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Exposure Group
n=103 Participants
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.
|
|---|---|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the First Trimester
Congenital Abnormalities, Fetal Death
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the First Trimester
Congenital Abnormalities, Live Birth
|
3 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the First Trimester
Congenital Abnormalities, Spontaneous Abortion
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the First Trimester
Congenital Abnormalities, Induced Abortion
|
1 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the First Trimester
No Congenital Abnormalities, Live Birth
|
60 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the First Trimester
No Congenital Abnormalities, Spontaneous Abortion
|
7 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the First Trimester
No Congenital Abnormalities, Fetal Death
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the First Trimester
No Congenital Abnormalities, Induced Abortion
|
5 Pregnancy Outcomes
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Exposure Group
n=103 Participants
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.
|
|---|---|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Second Trimester
Congenital Abnormalities, Live Birth
|
2 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Second Trimester
Congenital Abnormalities, Spontaneous Abortion
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Second Trimester
Congenital Abnormalities, Fetal Death
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Second Trimester
Congenital Abnormalities, Induced Abortion
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Second Trimester
No Congenital Abnormalities, Live Birth
|
11 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Second Trimester
No Congenital Abnormalities, Spontaneous Abortion
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Second Trimester
No Congenital Abnormalities, Fetal Death
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Second Trimester
No Congenital Abnormalities, Induced Abortion
|
0 Pregnancy Outcomes
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Exposure Group
n=103 Participants
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.
|
|---|---|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Third Trimester
Congenital Abnormalities, Live Birth
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Third Trimester
Congenital Abnormalities, Spontaneous Abortion
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Third Trimester
Congenital Abnormalities, Fetal Death
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Third Trimester
Congenital Abnormalities, Induced Abortion
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Third Trimester
No Congenital Abnormalities, Live Birth
|
1 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Third Trimester
No Congenital Abnormalities, Spontaneous Abortion
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Third Trimester
No Congenital Abnormalities, Fetal Death
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Third Trimester
No Congenital Abnormalities, Induced Abortion
|
0 Pregnancy Outcomes
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Exposure Group
n=103 Participants
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.
|
|---|---|
|
Number of Outcomes From Pregnancies With Reported Exposure During an Unspecified Trimester
Congenital Abnormalities, Live Birth
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Reported Exposure During an Unspecified Trimester
Congenital Abnormalities, Spontaneous Abortion
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Reported Exposure During an Unspecified Trimester
Congenital Abnormalities, Fetal Death
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Reported Exposure During an Unspecified Trimester
Congenital Abnormalities, Induced Abortion
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Reported Exposure During an Unspecified Trimester
No Congenital Abnormalities, Live Birth
|
7 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Reported Exposure During an Unspecified Trimester
No Congenital Abnormalities, Spontaneous Abortion
|
2 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Reported Exposure During an Unspecified Trimester
No Congenital Abnormalities, Fetal Death
|
0 Pregnancy Outcomes
|
|
Number of Outcomes From Pregnancies With Reported Exposure During an Unspecified Trimester
No Congenital Abnormalities, Induced Abortion
|
0 Pregnancy Outcomes
|
Adverse Events
Exposure Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER