the Safety of Anti-viral Drugs Used in Late Pregnancy Clinical Trial
Official title:
The Effect of Anti-viral Drugs Used in Late Pregnancy in Mothers With Hepatitis B Virus Infection on Long-term Development of Children
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 using nucleoside (acid) analogs in late pregnancy can
significantly reduce HBV DNA level and effectively blocking MTCT. Therefore, treatment
guidelines of hepatitis B in Europe and the Asia Pacific region clearly pointed out:
Nucleoside (acid) analogs can be used in pregnant women after 28 weeks of gestation for
blocking MTCT in mothers with high HBV DNA level. At present, the drugs used in late
pregnancy including lamivudine (LAM) ,telbivudine(LdT) and tenofovir(TDF).
The safety of nucleoside (acid) analogues used in late pregnancy on children is not clear.In
most of the related researches,the observation termination was 7-12 months after birth, and
most were concentrated on the blocking effect of MTCT.The long-term impact of Nucleoside
(acid) analogues on children's development has not been reported in the literatures. The aim
of this study is to make clear of the effect of nucleoside (acid) analogues used in late
pregnancy on long-term impact of children's development.
The one year old children born in Beijing Ditan hospital and whose mothers had taken LAM,LdT
or TDF during late pregnancy will be enrolled as study group, and eligible children whose
mothers untreated will be enrolled as control group. The children's height, weight,
nutritional status, developmental quotient and immune response to hepatitis B vaccine etc
will be evaluated at baseline and at 3 years old. By comparing the children's development in
different groups as well as in self-control of different ages, we will discuss the effect of
Nucleoside (acid) analogues on children's long-term development.
| Status | Enrolling by invitation |
| Enrollment | 400 |
| Est. completion date | December 2017 |
| Est. primary completion date | October 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Year to 3 Years |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Beijing Ditan Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The rate of abnormal development | The children' development will be measured by Gesell Developmental Scales, including adaptability, mobility, fine motion skills, language ability and social skills.The children will be considered normal if the score is =86, score between 76-85 is suspicious, and score=75 is abnormal. | 6 months | Yes |