Chronic Hepatitis B, Gestation
Conditions
Keywords
Chronic hepatitis B, Telbivudine, Intrauterine transmission
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Telbivudine in pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.
Detailed description
In the present study, we evaluated the effect of telbivudine given during the second and third trimesters of pregnancy to highly viremic, HBV DNA-positive mothers on maternal HBV DNA and HBeAg levels prior to delivery and the rate of vertical transmission of HBV to infants who received passive-active immunoprophylaxis. Additionally, we investigated the timing of the administration of telbivudine on reducing the risk of perinatal transmission and the safety of telbivudine during pregnancy.
Interventions
DRUGTelbivudine
Subjects start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continued to one month after delivery.
BIOLOGICALengineered HB vaccine
All the newborns in control group are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20 ug respectively at age of 0, 1 and 6 months.
Sponsors
Southeast University, China
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 20-40 years old pregnant woman with gestational age of 20-32 week; * positive serum HBsAg; * HBV DNA≥1.0x106 copies/ml;
Exclusion criteria
* with previous antiviral treatment; * with clinical sign of threatened miscarriage or related treatment in early pregnancy; * positive serum HAV, HCV, HDV and HEV tests; * fetus deformity by 3-D ultrasound examination; * on other dugs, such as immune modulators, cytotoxic drugs or steroids; * husbands are infected with HBV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the intrauterine transmission rate;vertical transmission rate (intrauterine and delivery) | 1 month post partum |
Secondary
| Measure | Time frame |
|---|---|
| liver function normalization rate; HBV DNA and HBeAg reduction and negative conversion rate; | 1 month post partum |
| drug adverse reaction in pregnant women; complications during pregnancy and delivery, gestational age at delivery, the method of delivery, peripartum hemorrhage, the newborn growth and development milestones, Apgar score, newborn deformity prevalence | .1 year after childbirth |
Outcome results
None listed