Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Age
Item
at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
HIV Serology negative
Item
negative human immunodeficiency virus (hiv) serology
boolean
C0019682 (UMLS CUI [1,1])
C0919674 (UMLS CUI [1,2])
Hepatitis B surface antigen positive | Hepatitis B e antigen positive
Item
positive hbsag and hepatitis b e antigen (hbeag) tests
boolean
C0149709 (UMLS CUI [1])
C0392390 (UMLS CUI [2])
Gestational Age Weeks
Item
gestational age of 28 weeks (+ or - 10 days) as determined by obstetrician
boolean
C0017504 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
Alanine aminotransferase measurement | Alanine aminotransferase measurement Confirmed by Blood draw
Item
alanine aminotransferase (alt)≤30 u/l, confirmed ≤60 u/l on a subsequent blood draw
boolean
C0201836 (UMLS CUI [1])
C0201836 (UMLS CUI [2,1])
C0521093 (UMLS CUI [2,2])
C0005834 (UMLS CUI [2,3])
Infants Present Study Site
Item
agreeing to bring their infants at the planned study visits at one study site until one year after delivery and to inform the site investigators if they plan to move to another place and not be able to return to the clinic.
boolean
C0021270 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C2825164 (UMLS CUI [1,3])
Infant Immunization | Blood draw Infants | Follow-up Needed
Item
understanding the need for adequate infant immunization and agreeing to the blood draws from their infants and the need for close follow up to manage possible exacerbation of hepatitis.
boolean
C0021270 (UMLS CUI [1,1])
C0020971 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0021270 (UMLS CUI [2,2])
C3274571 (UMLS CUI [3,1])
C0027552 (UMLS CUI [3,2])
Tenofovir | Other treatment Hepatitis B
Item
history of tenofovir treatment at any time, or any other anti-hbv treatment during the current pregnancy
boolean
C0384228 (UMLS CUI [1])
C2015819 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine clearance <50 ml/min, calculated using the cockcroft-gault formula
boolean
C2711451 (UMLS CUI [1])
Dipstick Proteinuria | Glycosuria normoglycemic
Item
dipstick proteinuria>1+ (>30 mg/dl) or normoglycemic glucosuria confirmed on two separate occasions
boolean
C1553114 (UMLS CUI [1,1])
C0033687 (UMLS CUI [1,2])
C0017979 (UMLS CUI [2,1])
C0580545 (UMLS CUI [2,2])
Serology positive Hepatitis C
Item
positive serology for hepatitis c infection less than 12 months prior to enrollment
boolean
C0242089 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
Fetal anomaly Pre-existing
Item
evidence of pre-existing fetal anomalies incompatible with life
boolean
C0000768 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Comorbidity Participation Contraindicated | Other treatment Participation Contraindicated | Comorbidity Follow-up Contraindicated | Other treatment Follow-up Contraindicated
Item
any concomitant condition or treatment that, in the view of the clinical site investigator, would contraindicate participation or satisfactory follow up in the study.
boolean
C0009488 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C1444657 (UMLS CUI [1,3])
C2015819 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C1444657 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
C1444657 (UMLS CUI [3,3])
C2015819 (UMLS CUI [4,1])
C3274571 (UMLS CUI [4,2])
C1444657 (UMLS CUI [4,3])
Study Subject Participation Status | Clinical Trial
Item
concurrent participation in any other clinical trial without written agreement of the two study teams
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])