| CTRI Number |
CTRI/2019/01/016946 [Registered on: 07/01/2019] Trial Registered Prospectively |
| Last Modified On: |
30/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on missing schools during menses reported by the adolescent girls in Udupi District |
|
Scientific Title of Study
|
A cross sectional study on self-reported school absenteeism during menstruation among adolescent girls in Udupi District. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Drushya N Shetty |
| Designation |
Student- MPH 3rd semester |
| Affiliation |
Prasanna School of Public Health, Manipal Academy of Higher Education |
| Address |
Department of Public Health, !st Floor, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9591620232 |
| Fax |
|
| Email |
drishyashetty12101@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Arathi Rao |
| Designation |
Coordinator, MPH Programme |
| Affiliation |
Prasanna School of Public Health, Manipal Academy of Higher Education |
| Address |
Department of Public Health, 1st Floor, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9008418848 |
| Fax |
|
| Email |
arathi.anil@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Drushya N Shetty |
| Designation |
Student- MPH 3rd semester |
| Affiliation |
Prasanna School of Public Health, Manipal Academy of Higher Education |
| Address |
Department of Public Health, 1st Floor, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9591620232 |
| Fax |
|
| Email |
drishyashetty12101@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Drushya N Shetty
MPH 2nd Semester, Department of Public Health, 1st Floor, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Drushya N Shetty |
| Address |
Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
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 Drushya N Shetty |
Schools of Udupi District |
Government, private aided and private unaided schools of Udupi district
Udupi
KARNATAKA |
9591620232
drishyashetty12101@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturaba Medical College and Kasturaba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Girls aged 13-16 years who have had missed their schools at least once during their menstruation since their menarche |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Female |
| Details |
Girls who have ever had missed school because of menstruation since menarche |
|
| ExclusionCriteria |
| Details |
Medical illness other than those due to menstruation
Girls who have never missed school because of menstruation since menarche
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will assess the factors affecting school absenteeism during menstruation |
Last week of April |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will assess the factors affecting school absenteeism during menstruation |
Last week of April |
|
|
Target Sample Size
|
Total Sample Size="1600"
Sample Size from India="1600"
Final Enrollment numbers achieved (Total)= "1546"
Final Enrollment numbers achieved (India)="1546" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/01/2019 |
| Date of Study Completion (India) |
30/05/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aims & objectives: Prevalence of self-reported school absenteeism during menstruation. To assess the factors affecting menstruation-related school absenteeism among adolescent girls. To compare the factors affecting menstruation-related school absenteeism between co-ed and girls school. Summary: Government, private aided and private unaided schools will be randomly selected from Udupi District. School girls aged 13-16 years, who have had missed their school at least once during menstruation since their menarche will be given consent forms to take part in the study. The ones who voluntarily agree to be a part of the study will be given ascent forms. All interviewees take part in the research voluntarily and they will be provided with a detailed description of how their anonymity is kept and personal information handled. The respondents will be given with structured questionnaires and the data will be collected. Data will be analyzed using SPSS V.16 and used only for research purpose. The study will assess the factors affecting school absenteeism during menstruation. |