| CTRI Number |
CTRI/2021/06/034487 [Registered on: 30/06/2021] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Incidence of congenital defect in spinal cord and its detection on antenatal ultrasonography in Odisha |
|
Scientific Title of Study
|
Incidence of neural tube defect and its detection on antenatal ultrasonography in an eastern Indian state: A population based cross sectional study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Santosh Kumar Mahalik |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) Bhubaneswar |
| Address |
Department of Pediatric Surgery,
All India Institute of Medical Sciences (AIIMS) Bhubaneswar.
Sijua, Patrapada.
Bhubaneswar. Odisha
Khordha
ORISSA
751019
India |
| Phone |
09866559002 |
| Fax |
|
| Email |
pedsurg_santosh@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Santosh Kumar Mahalik |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) Bhubaneswar |
| Address |
Department of Pediatric Surgery,
All India Institute of Medical Sciences (AIIMS) Bhubaneswar.
Sijua, Patrapada.
Bhubaneswar. Odisha
ORISSA
751019
India |
| Phone |
09866559002 |
| Fax |
|
| Email |
pedsurg_santosh@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Santosh Kumar Mahalik |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) Bhubaneswar |
| Address |
Department of Pediatric Surgery,
All India Institute of Medical Sciences (AIIMS) Bhubaneswar.
Sijua, Patrapada.
Bhubaneswar. Odisha
ORISSA
751019
India |
| Phone |
09866559002 |
| Fax |
|
| Email |
pedsurg_santosh@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research ICMR |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research ICMR |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Santosh Kumar Mahalik |
AIIMS Bhubaneswar |
Department of Pediatric Surgery, A2, OPD complex, AIIMS Bhubaneswar, Sijua, Patrapada,
Bhubaneswar
Khordha
ORISSA |
9866559002
pedsurg_santosh@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Women in reproductive age group |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women in the reproductive age group and who had a history of pregnancy |
|
| ExclusionCriteria |
| Details |
Women who are never pregnant |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We will get to know the incidence of neural tube defect of Odisha. |
a. preparatory phase (Recruitment, plannining and Training): 2 months
b. data collection: 12 months
c. analysis & report writing: 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| We will also get to know the effectiveness of PMSMA in preventing and detecting neural tube defects. |
a. preparatory phase (Recruitment, plannining and Training): 2 months
b. data collection: 12 months
c. analysis & report writing: 3 months |
|
|
Target Sample Size
|
Total Sample Size="153948"
Sample Size from India="153948"
Final Enrollment numbers achieved (Total)= "49"
Final Enrollment numbers achieved (India)="49" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/07/2021 |
| Date of Study Completion (India) |
18/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: Neural tube defect creates a burden on the family as well as the society. Managing a child with neural tube defect is difficult. The disability is preventable if proper antenatal Care is provided. The incidence of neural tube defect in Odisha is not known. The Government of India is providing antenatal care through Pradhan Mantri Surakshit Matrutya Abhiyan (PMSMA) which includes ultrasonogram during second and third trimester of pregnancy. The ultrasonogram can diagnose the problem antenataly. Many patients of neural tube defect present in the neonatal period where the parents were completely unaware of the condition although ultrasound has been done during the antenatal period. The mothers in reproductive age group are also not aware of folic acid and zinc supplementation during antenatal period. Novelty: It will be a first of kind study on estimation incidence of NTD in Odisha and it will also evaluate the functioning of the PMSMA programme in detection of NTD. This will be the first study from India on neural tube defect covering an entire state. Objective: The study will attempt to detect the incidence of neural tube defect in Odisha as well as will attempt to determine the effectiveness of the antenatal care provided specifically to prevent and diagnose the defect. Methods: Data collection regarding neural tube defect will be done by door to door survey of sample population by showing pictures and albums of different types of neural tube defect. Data will also be collected to analyze the results of ultrasound examination during antenatal period through PMSMA specifically for diagnosis of neural tube defect. Data will be analyzed. Expected Outcome: The study will determine the incidence of the neural tube defect and the effectiveness of diagnosis of the defect in antenatal period. It will create an awareness regarding the antenatal diagnosis of the defect among the service providers. |