Seroprevalence and outcome of Hepatitis B and C infections in antenatal women

All pregnant females visiting the outpatient department and labour room of the department of Obstetrics and Gynaecology will be enrolled in the study. A detailed history including socio-demographic history, maternal parameters like parity, maternal age, obstetric history with mode and place of delivery in previous pregnancies, menstrual history, personal history, and any high-risk comorbidity will be recorded as per structured proforma. After obtaining informed consent the blood samples of the participants will be collected in serum gel vials. The separated serum will be checked for the presence of hepatitis B surface antigen (HBsAg) and IgG antibodies to HCV using the Rapid/ELISA Test for the qualitative detection of HBsAg and HCV in human serum. If HBsAg Rapid test is positive HBV viral load will be done by an Automated Cartridge based system and HBeAg will be tested by the Rapid diagnostic Test in the Microbiology laboratory.  HCV viral load will be done by Automated Cartridge based system for seropositive patients. As a part of routine investigation, blood samples will also be collected in EDTA vial for complete blood counts including platelet count. Serum alanine transaminase (ALT) and aspartate transaminase (AST) levels will be measured to evaluate liver function test. It is recommended to use noninvasive techniques (NIT) like APRI for assessing the extent of fibrosis. APRI (AST-to-platelet ratio index) will be calculated. An APRI score of 2 or more is suggestive of cirrhosis and an indication to start treatment for hepatitis B infection.

The women who are seropositive for hepatitis B or C infection will be evaluated based on a questionnaire for the presence of risk factors for hepatitis B and C infection and pregnancy outcome. Maternal risk factors for hepatitis B and C like use of intravenous drugs, history of IM injections from quacks, history of hepatitis infection in husband or family, history of blood transfusion, and tattooing will be recorded.

OUTCOME MEASURES: Fetal outcome will be studied in terms of gestational age at delivery, birth weight, incidence of prematurity, APGAR score, neonatal jaundice requiring phototherapy, need of NICU admission and perinatal mortality. Liver function test of neonate will also be done to find if there is correlation of maternal infection with fetal outcome. Maternal outcome variables will include gestational age at time of delivery, mode of delivery, thrombocytopenia, postpartum haemorrhage and other complications. Other complications include gestational diabetes, preeclampsia, preterm labour pains. The outcome measures will be studied in patients who are seropositive for hepatitis B or C infection.

According to the national action plan combating viral hepatitis in India under NVHCP, treatment of hepatitis B infection will be started for patients with viral load greater than 200,000IU/ml or APRI score more than 2 as per the recommendations. HBV DNA levels will be done again between 24-28 weeks of gestation for patients who had low viral load and presented at early gestation. Treatment of hepatitis B in pregnancy will be started if HBV DNA level is greater than 200,000IU/ml which is antiviral therapy with tenofovir disoproxil fumarate at a dose of 300 mg starting from 32 to 36 weeks of pregnancy until delivery and will be continued for 3 months postpartum. The treatment will be given according to the guidelines and standard protocols for hepatitis B infection. The risk of transmission of Hepatitis C infection is low and the teratogenic effect and safety of DAAs (direct-acting antivirals) in pregnancy is not known. Therefore the treatment of hepatitis C is deferred till the completion of breast feeding. Counselling is of vital importance in case of hepatitis C infection to follow up for treatment after 6-8 months of delivery.