| CTRI Number |
CTRI/2021/04/032615 [Registered on: 07/04/2021] Trial Registered Prospectively |
| Last Modified On: |
06/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Survey to Assess Potential Acceptance of COVID 19 Vaccine in Pregnant and Lactating Women |
|
Scientific Title of Study
|
Potential Acceptance of COVID 19 Vaccine in Pregnant and Lactating Women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIl |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kanav Khera |
| Designation |
Assistant Professor - Selection Grade |
| Affiliation |
Manipal College of Pharmaceutical Sciences, MAHE |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences
Udupi
KARNATAKA
576104
India |
| Phone |
7889271828 |
| Fax |
|
| Email |
kanavworld@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanav Khera |
| Designation |
Assistant Professor - Selection Grade |
| Affiliation |
Manipal College of Pharmaceutical Sciences, MAHE |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences
Udupi
KARNATAKA
576104
India |
| Phone |
7889271828 |
| Fax |
|
| Email |
kanavworld@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Hafsa Shaikh |
| Designation |
Undergraduate Student |
| Affiliation |
Manipal College of Pharmaceutical Sciences, MAHE |
| Address |
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences
Udupi
KARNATAKA
576104
India |
| Phone |
7619503973 |
| Fax |
|
| Email |
hafsashaikh915@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, Manipal, Karnataka |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Kanav Khera |
Kasturba Medical College and Hospital, MAHE |
Department of Gynecology and Obstetrics
Udupi
KARNATAKA |
7889271828
kanavworld@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant and Lactating Women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant and Lactating Women |
|
| ExclusionCriteria |
| Details |
Women who are surrogates are not eligible for the study
Women who are not willing to participate due to any reason |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| at the end of the survey we will be able to determine prevalence and acceptance of COVID 19 vaccine in pregnant and lactating population |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Barriers faced by pregnant and lactating women to get vaccinated |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
12/04/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
survey will be conducted using physical form as well as electronic form which will be filled by representee in the presence of individuals after full filling the inclusion and exclusion criteria. the survey includes demographic question as well as self prepared questionnaire. the survey is specific to individuals visiting OB-GYN and is limited to those individuals who are pregnant and lactating women. the survey may focus on different types of topics such as demographic information, risk assessment, current status of the patient, potential acceptance toward vaccine during pregnancy and lactation. Consent form will be available in English and Kannada language. Upon the subject agreement to participate in the given consent form they will be able to respond through questionnaire. |