Prevention for Mother-to-infant Transmission of HBV
HBIG for Prevention of Mother-to-infant HBV Transmission
Study Overview
Detailed Description
Twenty-eight HBsAg-positive pregnant women who underwent consultation were recruited from the First Affiliated Hospital of Xi'an Jiaotong University, Shaanxi, China. Twelve of these women willing to receive HBIG administration were assigned to experimental group, while another sixteen without HBIG injection were enrolled as control group. The exclusion criteria for participants were: 1) infection with toxoplasmosis, syphilis, parvovirus B19, rubella, cytomegalovirus, herpes, hepatitis C, HIV, or other viruses; 2) obstetric diseases such as pregnancy-related hypertension, placental abruption, threatened miscarriage, and others.
The 12 pregnant women enrolled willing to receive injections of HBIG (200 IU, S20023028, Hualan Biological Engineering Inc.) beginning at week 20 of gestation (at weeks 20, 24, 28, 32, 34, 36, 38, 39, and 40). The control group only underwent regular examinations without any HBIG treatment during pregnancy. All the infants born received combined immunoprophylaxis (HBIG, 200 IU, and the first dose of the hepatitis B vaccine, 5 μg, S19983018, Shenzhen Kangtai Biological Products Co. Ltd.) at different injection sites within 12 h postpartum.
Data of mothers were collected from medical records that included complete healthcare information before and after delivery. Each infant was consecutively followed up after birth, growth index (weight, length and head circumference), feeding patterns and serum level of HBV DNA and viral markers were recorded. Serum HBV markers (HBsAg, HBsAb, HBeAg, and HBcAb) titers、HBV DNA load and liver function of mothers were regularly measured during pregnancy. Serum HBsAg, HBsAb titer and HBV DNA load of infants were tested at birth, the age of 7 and 12 months. Placental tissue sections were used for immunohistochemical staining of HBsAg (mouse, 1:50, ZM-0122, Beijing Zhongshan Golden Bridge Biotechnology Co.), HBIG (rabbit, 4.7 mg/ml, 1:2500, prepared as described above), and CD68 (mouse, 1:25, ab955, Abcam).
Adverse outcome, HBV infection rate of infants, HBV markers titers, liver function and HBV DNA load of mothers, correlation between mothers and newborns regarding HBsAb titer and histopathological changes in placenta samples were compared between experimental group and control group.
Statistical analysis was performed using SPSS 13.0 statistical software (SPSS Inc., Chicago, USA). Data were expressed as the mean ± standard deviation (SD). The data were analyzed with the Shapiro-Wilk test and the Levene statistic for normality and homogeneity of variance, respectively. The difference between two quantitative groups was compared with an independent-sample t-test or the Mann-Whitney U-test as appropriate, and correlations were analyzed with the Pearson or Spearman correlation test. The chi-square test or Fisher's exact test was used to compare the proportions of the two groups. All tests were two-tailed with the risk set at 5%, and the statistical significance was set as p < 0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HBsAg positive for more than 6 months, gestational age less than 20 weeks
Exclusion Criteria:
- infection with toxoplasmosis, syphilis, parvovirus B19, rubella, cytomegalovirus, herpes, hepatitis C, HIV, or other viruses; obstetric diseases such as pregnancy-related hypertension, placental abruption, threatened miscarriage, and others.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: HBIG group
Mothers in HBIG group received 'Hepatitis B immunoglobulin' (HBIG 200 IU, S20023028, Hualan Biological Engineering Inc.) injection at gestational weeks 20, 24, 28, 32, 34, 36, 38, 39, and 40.
|
Hepatitis B immunoglobulin 200 IU injection at gestational week 20, 24, 28, 32, 34, 36, 38, 39, and 40 in HBIG group mothers.
Other Names:
|
|
NO_INTERVENTION: Control group
Mothers in control group had no HBIG injection during pregnancy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HBV infection of infants
Time Frame: one year
|
HBV DNA and HBsAg positive at the age of 1 year old
|
one year
|
|
Histopathological changes in placenta
Time Frame: at delivery
|
Immunohistochemical staining of HBsAg, HBIG and CD68
|
at delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum HBV markers titers、HBV DNA load and liver function changes
Time Frame: at weeks 20, 24, 28, 32, 34, 36, 38, 39, and 40 of gestation
|
Serum HBV markers (HBsAg, HBsAb, HBeAg, and HBcAb) titers、HBV DNA load and liver function of mothers were regularly measured.
|
at weeks 20, 24, 28, 32, 34, 36, 38, 39, and 40 of gestation
|
|
Adverse events
Time Frame: at weeks 20, 24, 28, 32, 34, 36, 38, 39, and 40 of gestation, at delivery, at the age of 7 and 12 months of infants
|
Reports of premature and partum complications, ALT flare, delivery mode and birth defects.
|
at weeks 20, 24, 28, 32, 34, 36, 38, 39, and 40 of gestation, at delivery, at the age of 7 and 12 months of infants
|
Collaborators and Investigators
Investigators
- Study Chair: Tianyan Chen, MD, The First Affiliated Hospital of Medical College, Xi'an Jiaotong University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012ZX10002007-001-001 -1
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