| CTRI Number |
CTRI/2024/12/078443 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand how COVID-19 vaccination affects menstrual cycle patterns in women living in selected rural areas. |
|
Scientific Title of Study
|
A study to Assess correlation between Menstrual Cycle Pattern and Covid 19 vaccination among females in selected rural areas |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lalhminghlui |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Obstetrics and Gynecological nursing
SRMMCON Building
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9366383970 |
| Fax |
|
| Email |
mapuii1995hlui@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manjusha Mahakarkar |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Obstetrics and Gynecological nursing
SRMMCON Building
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766565719 |
| Fax |
|
| Email |
manjum4725@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manjusha Mahakarkar |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Obstetrics and Gynecological nursing
SRMMCON Building
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766565719 |
| Fax |
|
| Email |
manjum4725@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Wardha Maharashtra, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha, Maharashtra India 442001 |
| 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 Lalhminghlui |
Smt Radhikabhai Meghe College of Nursing |
Department of Obstetrics and Gynecological,Ground floor, Room no 2, Sawangi Meghe, Wardha, Maharashtra India
Wardha
MAHARASHTRA |
9366383970
mapuii1995hlui@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Menstruating Women from the Community |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Females who are willing to participate.
2. Females who are in a specified age range (21-35 years)
3. Females who are available during data collection.
4. Females who are having regular menstrual cycle
|
|
| ExclusionCriteria |
| Details |
1. Females who are conceived
2. Females who have psychological illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be correlation between Menstrual Cycle Pattern and Covid 19 vaccination |
Assessment will be done at the end of 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
15/01/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Menstruation is a monthly shedding of the
uterine wall, presented by menstrual bleeding in women of reproductive age.
Menstruation is regulated by fluctuation of estrogen and progesterone,
as well as other endocrine and immune pathways. Many women experienced menstrual
disturbances after vaccination against the novel coronavirus in
the last two years. Vaccine-induced menstrual disturbances have led to
discomfort and concern among reproductive-age women, such that some decided not
to receive the subsequent doses of the vaccine. Although many vaccinated women
report these menstrual disturbances, the mechanism is still poorly understood.
This review article discusses the endocrine and immune changes following
COVID-19 vaccination and the possible mechanisms of vaccine-related menstrual
disturbances. The
investigator will introduce self and inform subjects about the nature of the
study so as to ensure better co-operation during the data collection.
Investigator will enquire their willingness to participate in the study and
will obtain written consent from the subjects. Questionnaire will be
distributed among the participant.
|