Status:
UNKNOWN
The Effect of Anti-viral Drugs Used in Late Pregnancy on Long-term Development of Children
Lead Sponsor:
Beijing Ditan Hospital
Conditions:
the Safety of Anti-viral Drugs Used in Late Pregnancy
Eligibility:
All Genders
1-3 years
Brief Summary
Mother to child transmission(MTCT) is the main route of hepatitis B virus(HBV) transmission.High HBV DNA level of pregnant women is the main risk factor of MTCT. Many literatures demonstrate that usin...
Eligibility Criteria
Inclusion
- The one year old children whose mothers had taken Lamivudine,Telbivudine or Tenofovir in late pregnancy(28-30 weeks of gestation);
- The one year old children whose mothers untreated in late pregnancy;
- Children had completed standard hepatitis B vaccine and hepatitis B immune globulin combined active and passive prophylaxis;
- HBV DNA level of the children's mothers were over 6.0 log10 IU/ml before 28 weeks of gestation.
Exclusion
- Children whose mothers over 35 years old at delivery;
- The couple having family hereditary disease or abnormal malformation has been found at fetal screening before 28 weeks gestation;
- History of amniocentesis during pregnancy;
- Co-infection with either hepatitis C virus, hepatitis D virus, human immunodeficiency virus, syphilis, toxoplasmosis, rubella or cytomegalovirus.
- Complications of pregnancy-induced hypertension, premature rupture of membranes, preterm birth, placenta previa or placental abruption; asphyxia at birth.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT02301650
Start Date
October 1 2014
End Date
December 1 2017
Last Update
November 26 2014
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