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CTRI Number  CTRI/2024/07/070255 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 06/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Hepatitis B and C prevalence in pregnant women and maternal and fetal outcome in positive women 
Scientific Title of Study   Seroprevalence and outcome of Hepatitis B and C infections in antenatal women 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sakshi Jain 
Designation  Post graduateJunior Resident 
Affiliation  Government medical college and hospital, sector 32, Chandigarh 
Address  Department of Obstetrics and gynaecology, level 4 D block Government Medical College and Hospital, Sector 32,Chandigarh. Pin code 160030

Chandigarh
CHANDIGARH
160030
India 
Phone  9815859139  
Fax    
Email  sakshi.angel97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Navneet Takkar 
Designation  Professor 
Affiliation  Government medical college and hospital, sector 32, Chandigarh 
Address  Department of Obstetrics and gynaecology, level 4 D block Government Medical College and Hospital, Sector 32,Chandigarh. Pin code 160030

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121582  
Fax    
Email  navneettakkar2015@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Navneet Takkar 
Designation  Professor 
Affiliation  Government medical college and hospital, sector 32, Chandigarh 
Address  Department of Obstetrics and gynaecology, level 4 D block Government Medical College and Hospital, Sector 32,Chandigarh. Pin code 160030

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121582  
Fax    
Email  navneettakkar2015@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College and Hospital, sector 32, Chandigarh 
 
Primary Sponsor  
Name  Government Medical College ang Hospital 
Address  Department of Obstetrics and gynaecology, level 4 D block Government Medical College and Hospital, Sector 32,Chandigarh. Pin code 160030  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sakshi Jain  Government Medical College and Hospital  Department of Obstetrics and Gynaecology, D-block(level 4) Sector 32, Chandigarh PIN CODE 160030
Chandigarh
CHANDIGARH 
9815859139

sakshi.angel97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE(GMCH,Chandigarh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O984||Viral hepatitis complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Tenofovir disoproxil fumarate   Pregnant women with hepatitis B seropositive with HBV DNA level more than 200,000IU/mL or APRI score more than 2 will be given tenofovir disoproxil fumarate at dose of 300mg starting from week 32 to 36 of pregnancy and will be continued 3 months postpartum as per NHVCP guidelines.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Pregnant women visiting the outpatient department and labour room will be screened for HBV and HCV infection and seropositive women will be studied for maternal and fetal outcomes. 
 
ExclusionCriteria 
Details  None as hepatitis B and C screening is recommended for all pregnant women.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the seroprevalence of hepatitis B and C in antenatal women   baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate maternal & neonatal outcome among pregnant women with hepatitis B & C infection at time of delivery  3-4 days 
 
Target Sample Size   Total Sample Size="2187"
Sample Size from India="2187" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 proformaAfter 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.


 
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