Clinical Trial: Prevention for Mother-to-infant Transmission of HBV

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: HBIG for Prevention of Mother-to-infant HBV Transmission

Brief Summary: In this study, HBV-infected pregnant women were divided into two groups, those who received and those who did not receive hepatitis B immunoglobulin (HBIG) during pregnancy. In the mothers, the changes in HBV serum markers (hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), HBeAg, hepatitis B core antibody (HBcAb)), and the DNA load were investigated. Immunohistochemical staining with custom-made antibodies against HBIG revealed both the level and distribution of HBIG in placentas. The protective mechanism of HBIG administrated during pregnancy was explored.

Detailed Summary:

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, Beij
Sponsor: Health Science Center of Xi’an Jiaotong University

Current Primary Outcome:

• HBV infection of infants [ Time Frame: one year ]
  HBV DNA and HBsAg positive at the age of 1 year old
• Histopathological changes in placenta [ Time Frame: at delivery ]
  Immunohistochemical staining of HBsAg, HBIG and CD68

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.
• 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.

Original Secondary Outcome: Same as current

Information By: Health Science Center of Xi’an Jiaotong University

Dates:
Date Received: December 2, 2014
Date Started: May 2012
Date Completion:
Last Updated: December 8, 2014
Last Verified: December 2014