| 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
|
|
|
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
|
|
|
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 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.
|