| CTRI Number |
CTRI/2023/09/057276 [Registered on: 06/09/2023] Trial Registered Prospectively |
| Last Modified On: |
14/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Serum Folic acid level among first trimester pregnant ladies |
|
Scientific Title of Study
|
Correlation of serum folic acid level with knowledge and practice of periconceptional folic acid intake among pregnant 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 Varsha Shenoy |
| Designation |
Professor, Dept of Anatomy |
| Affiliation |
Father Muller Medical College |
| Address |
Father Muller Medical College, Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9880539306 |
| Fax |
|
| Email |
varsha.shenoy@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varsha Shenoy |
| Designation |
Professor, Dept of Anatomy |
| Affiliation |
Father Muller Medical College |
| Address |
Father Muller Medical College, Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9880539306 |
| Fax |
|
| Email |
varsha.shenoy@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha Shenoy |
| Designation |
Professor, Dept of Anatomy |
| Affiliation |
Father Muller Medical College |
| Address |
Father Muller Medical College, Kankanady, Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9880539306 |
| Fax |
|
| Email |
varsha.shenoy@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Research Centre, Father Muller Charitable Instituitions, Mangalore |
|
|
Primary Sponsor
|
| Name |
Father Muller Research centre |
| Address |
Father Muller Charitable Instituitions, Kankanady, Mangalore-575002 |
| Type of Sponsor |
Private 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 Varsha Shenoy |
Father Muller medical College Hospital |
Department of OBG, Department of Anatomy, Biochemistry Lab of Research centre
Dakshina Kannada
KARNATAKA |
9880539306
varsha.shenoy@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women in their first trimester pregnancy who visit the hospital for first time. |
|
| ExclusionCriteria |
| Details |
Pregnant ladies in their second or third trimester, Who are visiting for subsequent antenatal checkups |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum folic acid level of the pregnant ladies in their first trimester in the particular region |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Knowledge & practice of using periconceptional folic acid among the pregnant women of the region |
6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/09/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The study will be using pregnant ladies in their first trimester after obtaining voluntary informed consent. When these ladies visit the hospital for first time for their antenatal checkup, they will be administered with a semistructured questionnaire to understand the knowledge and practice of using periconceptional folic acid in the particular region. A blood sample will be collected from each participant during their routine investigation and sample will be sent to estimate the serum folic acid level. This will be done using Human Elisa Kit. The study results will give us an idea about the serum folic acid among the young ladies in the geographic region as well as provide us the awareness level among ladies of the region. |