An observational study in Hepatitis B, sponsored by Huashan Hospital. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-12.
Sponsored by Huashan Hospital · Observational
The effective control of nucleos(t)ide analogues for patients infected with hepatitis B has significantly curbed the horizontal transmission of hepatitis B. However, the vertical transmission remains a serious threat to public health for directly increasing the burden of hepatitis B worldwide with the transmission rate up to 80 to 90% among high HBV DNA level if untreated. Currently, the effective prevention of mother-to-child transmission is credited to the implement of HBV vaccination and hepatitis B virus immunoglobin. To leave nobody behind, a growing body of evidence has been yielded to support the use of nucleos(t)ide analogues in the mothers during the late pregnancy. However, the clinical practice can be more complex. Therefore, investigators aim to assess the effectiveness of maternal antiviral therapy and different infants immunoprophylaxis strategy in the prevention of chronic hepatitis infection among children whose mothers were infected with chronic hepatitis B infection in the real world setting.
From 2011 to 2017, the investigators consecutively enrolled the pregnant women with chronic hepatitis B infection who were less than 28 weeks pregnant and not treated with nucleos(t)ide analogues during pregnancy. The investigators recommended those pregnant women with HBV DNA > 2*10\^6 IU/ml to receive nucleos(t)ide analogues from 28 weeks of pregnancy to delivery. Patients who agreed the antiviral treatment would assigned to the treatment group and those who declined it were assigned to the control group with high HBV DNA level. Meanwhile, those pregnant women with HBV DNA \< 2*10\^6 IU/ml was assigned as the control group with low HBV DNA level. All infants would be instructed to receive hepatitis B vaccine and hepatitis B virus immunoglobulin within 24 hours after birth, defined as the standard immunoprophylaxis strategy and encouraged to receive immunoprophylaxis within 2 hours after birth, defined as the aggressive immunoprophylaxis strategy. Umbilical cord blood were collected to determine the HBV serological markers and HBV DNA level. Children were followed every three to four years until December 2018.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 233 is close to the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Huashan Hospital is the lead sponsor of 239 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
In the real-world setting, we recruited consecutively HBsAg positive women who were less than 28 weeks pregnant and underwent routine testing for HBV at the Department of Infectious Diseases of Taicang First People's Hospital at least twice during pregnancy. Patients were excluded from participation if they had been treated with antiviral drugs during pregnancy. Additional exclusion criteria were drug hypersensitivity, abnormal renal laboratory results, coinfection with human immunodeficiency virus or other human hepatitis viruses.
Exclusion Criteria:
Pregnant women with high HBV DNA level \> 2\*10\^6 IU/ml who agree to receive the antiviral treatment during the late pregnancy.
Drug: nucleos(t)ide analogue
Pregnant women with high HBV DNA level \> 2\*10\^6 IU/ml who decline to receive the antiviral treatment during the late pregnancy.
Pregnant women with high HBV DNA level \< 2\*10\^6 IU/ml
Pregnant women in this group agree to receive nucleos(t)ide analogue (tenofovir or telbivudine) daily from the 28 weeks of pregnancy to delivery.
The proportion of children who developed chronic HBV infection between the treatment group and two control groups in the real-world setting.
We compare the proportion of children with chronic HBV born to mothers from three groups in the real life setting
Time frame: December, 2018
the proportion of children who developed chronic HBV infection between the treatment group and two control groups among infants who followed the standardized immunoprophylaxis strategy
We compare the proportion of children with chronic HBV born to mothers from three groups who followed the standardized immunoprophylaxis strategy
Time frame: December, 2018
the proportion of children who developed chronic HBV infection between the treatment group and two control groups among infants who followed the aggressive immunoprophylaxis strategy
We compare the proportion of children with chronic HBV born to mothers from three groups who followed the aggressive immunoprophylaxis strategy
Time frame: December, 2018
The proportion of children with detectable HBV DNA and HBsAg in umbilical cord blood
We compare the proportion of children with detectable HBV DNA and HBsAg in umbilical cord blood born to mothers from three groups
Time frame: At delivery
The HBV DNA level of mothers among three groups
We compare the HBV DNA level of mothers among three groups within one week before delivery.
Time frame: Within one week before delivery.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Huashan Hospital