| CTRI Number |
CTRI/2023/01/048851 [Registered on: 10/01/2023] Trial Registered Prospectively |
| Last Modified On: |
31/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Trial to study the incidence of hemoglobinopathies in antenatal women lessthan 20 weeks attending tertiary care centre |
|
Scientific Title of Study
|
Antenatal Screening for Hemoglobinopathies in a Tertiary Care Centre - One Year Descriptive Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GURRALA SNEHA |
| Designation |
Post Graduate |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Jawaharlal Nehru Medical College, KLES Dr Prabhakar Kore Hospital, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7037136131 |
| Fax |
|
| Email |
snehareddygurrala.31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrM B Bellad |
| Designation |
Chief Consultant |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, KLES Dr Prabhakar Kore Hospital, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448124893 |
| Fax |
|
| Email |
mbbellad@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GURRALA SNEHA |
| Designation |
Post Graduate |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Jawaharlal Nehru Medical College, KLES Dr Prabhakar Kore Hospital, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7037136131 |
| Fax |
|
| Email |
snehareddygurrala.31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College and KLES Dr.Prabhakar Kore Hospital and Medical Research Centre, Belagavi |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Jawharlal Nehru Medical College and KLES Dr.Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagvi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gurrala Sneha |
KLES Dr Prabhakar Kore Hospital, Belagavi |
OPD No. 10, Department of Obstetrics and Gynaecology,
Belgaum
KARNATAKA |
7037136131
snehareddygurrala.31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All antenatal women attending OBGYN OPD at KLEH with period of gestation lessthan 20 weeks |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All Antenatal women with period of gestation less than 20 weeks(calculated by reliable LMP/scan) attending OBGYN OPD |
|
| ExclusionCriteria |
| Details |
women who are already known cases of hemoglobinopathies and who are not willing to participate in this study |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Screening of antenatal women lessthan 20 weeks POG for hemoglobinopathies for the prevalence of hemoglobinopathies in antenatal women attending tertiary care centre |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To screen Preganant women for hemoglobinopathies and increase awareness among general population and offering prenatal diagnosis to couples at risk of having abnormal child |
1 year |
|
|
Target Sample Size
|
Total Sample Size="196"
Sample Size from India="196"
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)
|
20/01/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hemoglobinopathies are group of diseases characterised by abnormalities both qualitative and quantitative in the production of hemoglobin. The WHO estimates that overall at least 5.2% of the world population carry a significant variant of hemoglobinopathies. The most effective approach to reduce the burden of the society is to reduce the incidence by implementation of carrier screening programme. Detection of carrier status using complete hemogram and Hb Electrophoresis during pregnancy assess prevalence of hemoglobinopathies in pregnant women and provides prospective parents with the option of prenatal diagnosis for testing their fetus for hemoglobinopathies and also increase awareness among general population about prevention of birth of genetically abnormal child. |