FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/05/014059 [Registered on: 23/05/2018] Trial Registered Retrospectively
Last Modified On: 27/05/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Cluster Randomized Trial 
Public Title of Study   a study of menstrual problems in adolescents 
Scientific Title of Study   MENSTRUAL PROBLEMS IN UNDERGRADUATES MEDICAL STUDENTS: A CROSS SECTIONAL STUDY IN A MEDICAL COLLEGE OF NORTH INDIA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Gaurika Joshi 
Designation  MBBS 3rd Year student 
Affiliation  Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana  
Address  Department of Obstetrics & Gynaecology Dept Of Obs and Gynae Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana

Ambala
HARYANA
133207
India 
Phone    
Fax    
Email  gaurikajoshi123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Indu Verma 
Designation  Associate Professor 
Affiliation  Maharishi Markandeshwar Institute of Medical Sciences and Research, 
Address  Department of Obstetrics & Gynaecology
Mullana
Ambala
HARYANA
133207
India 
Phone    
Fax    
Email  drinduverma68@gmail.com  
 
Details of Contact Person
Public Query  
Name  Indu Verma 
Designation  Associate Professor 
Affiliation  Maharishi Markandeshwar Institute of Medical Sciences and Research, 
Address  Department of Obstetrics & Gynaecology
Mullana
Ambala
HARYANA
133207
India 
Phone    
Fax    
Email  drinduverma68@gmail.com  
 
Source of Monetary or Material Support  
MMIMSR Mullana 
 
Primary Sponsor  
Name  MMIMSR Ambala 
Address  Mullana Ambala 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Gaurika Joshi  Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana   Department of Obstetrics & Gynaecology
Ambala
HARYANA 		 9814046817

gaurikajoshi123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  MBBS female students staying in the hostel of the college 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Medical undergraduate females studying in our institute 
 
ExclusionCriteria 
Details  Unwilling students 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study common menstrual problems in medical students  On analyzing the questionnaire  
 
Secondary Outcome  
Outcome  TimePoints 
Future planning of the management of menstrual problems detected  After analyzing the questionnaire 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   25/03/2018 
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)  Open to Recruitment 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Introduction:
Menstruation is a natural physiological process that is a part of a woman’s reproductive health. It is experienced by all females every month. Menstruation is the visible manifestation of cyclic physiologic uterine bleeding due to shedding of the endometrium following invisible interplay of hormones mainly through hypothalami-pituitary-ovarian axis. Once the menstruation starts,it comes at intervals of 21-35 days with a mean of 28 days. The duration is about 4-5 days and the amount of blood loss is estimated to be 20-80 ml with average of 35 ml. For some these days are as normal as regular days but for others it is quite a challenging time. Lack of awareness among young girls and different taboos are responsible for the hesitation,shyness and fear in sharing problems.1The prevalance of menstrual disorders can be as high as 87%.2 Various menstrual disorders are amenorrhea,irregular cycles,abnormal flow to dymenorrhea and premenstrual symptoms.Among which commonest is dysmenorrhea with prevalence of 60%-90%.3 Dysmenorrhea and premenstrual syndrome are cause for absenteeism and limitation of social and physical activities.4Sometimes, these menstrual problems effect the general health of young female and also effects their performance academically and this leads to stress.

Aim :
1. Prevalence of menstrual problems in medical undergraduates.
2. Associated factors
3. Common menstrual problems in medical undergraduates students.

Method & Material :
Type of study – Cross sectional study Study period - 2 months (april 2018-may 2018) Study population – Study will be conducted on 200 medical undergraduate females studying in our institute.

Exclusion criteria : Unwilling students

Study Tool : Interview based as per pre tested semi structural questionnaire which will comprise sociodemographic details of students & various menstrual problems experienced by them. 

Further data will be analyzed using SPSS VERSION 20 software and association among various variable will be determined.
P value < 0.05 will be considered significant.

Tool design :
Questionnaire - Students will be given proforma that will be filled anonymously. - The proforma contain questions related to: -BMI - Cycle - Regularity - Abnormal bleeding - Associated premenstrual symptoms - Abnormal discharge - Absenteeism from class Research will be started only after ethical clearance by our institute.

Statistics : Data will be analysed using SPSS VERSION 20 software and association among various variable will be determined.
Pvalue <0.05 will be considered significant.

References :
1. Shukla MK ,Khan S ,Srivastava A .Common menstrual complaints and use of medication ,among undergraduate students of Moradabad ,Uttar Pradesh. India: a cross sectional study .Int. J Community Med Public Health. 2016;3(8):2180-5.
2. Narayan KA Srinivasa DK ,Petlo PJ , Veerammal S; Puberty rituals ,reproductive knowledge and health of adolescents schoolgirls in South India .Asia Pacific Population Journal ,2001 ; 16(2) : 225-238.
3.Campbell M ,McGrath P ; Use of medication by the adolescents for the management of menstrual discomfort ,Arch Pediatr Adolesc Med.,1997;151(9) ;905 -912.
4.Singh A,Kiran D , Singh H ,Nel B , Singh P ,Tiwari P ; Prevalance and severity of dysmenorrhea : A problem related to menstruation among first and second year female medical students.Indian J Physiol Pharmacol., 2008;52(4) :389-397.
 
Close