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CTRI Number  CTRI/2023/10/058819 [Registered on: 18/10/2023] Trial Registered Prospectively
Last Modified On: 15/10/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Menstrual Hygiene Product]  
Study Design  Other 
Public Title of Study   Acceptability and Feasibility of menstrual cup among married women of reproductive age: A Quasi Experimental Study 
Scientific Title of Study   Acceptability and feasibility of Menstrual Cup among married women of reproductive age: a quasi-experimental study 
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 Ankita Kankaria 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Bathinda 
Address  Department of Community and Family Medicine AIIMS Bathinda

Bathinda
PUNJAB
151001
India 
Phone  9646259076  
Fax    
Email  Kankariaankita@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ankita Kankaria 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Bathinda 
Address  Department of Community and Family Medicine AIIMS Bathinda

Bathinda
PUNJAB
151001
India 
Phone  9646259076  
Fax    
Email  Kankariaankita@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ankita Kankaria 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Bathinda 
Address  Department of Community and Family Medicine AIIMS Bathinda

Bathinda
PUNJAB
151001
India 
Phone  9646259076  
Fax    
Email  Kankariaankita@gmail.com  
 
Source of Monetary or Material Support  
Ambuja Cement Foundation, Near Guru Nanak Dev Thermal Plant, Bathinda 151002 
 
Primary Sponsor  
Name  NIL 
Address  Not applicable 
Type of Sponsor  Other [not applicable] 
 
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 
Dr Ankita Kankaria  All India Institute of Medical Sciences Bathinda  AIIMS Bathinda Punjab 151001
Bathinda
PUNJAB 		 9646259076

Kankariaankita@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ALL INDIA INSTITUTE OF MEDICAL SCIENCES BATHINDA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Married women of reproductive age meeting inclusion criteria 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Menstrual Cup  Eligible women will be given menstrual cup and feasibility will be seen among married women in the reproductive age group 
Comparator Agent  Menstrual Cup  The same group of women will act as controls. It is a Quasi Experimental Study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  1. Women who are non-pregnant
2. who do not have gynaecological issue (cervicitis, vaginitis, prolapse etc.)
3. Who are currently using menstrual products other than menstrual cups
 
 
ExclusionCriteria 
Details  1. Women with a history suggestive of intellectual disability will be excluded
2. Females in the reproductive age group (18-49 years) who have not attained menarche
3. Females in the reproductive age group (18-49 years) who have menopause due to physiological/surgical reasons
4. Did not give consent to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Feasibility and Acceptability of using menstrual cup among married reproductive age women..  At the end of 1 month, 3 month, 6 month and 1 year after introduction of menstrual cups 
 
Secondary Outcome  
Outcome  TimePoints 
development of context specific awareness material on menstrual cup usage  At the time of training in Phase II & revision if required at the end of 1 year after introduction of menstrual cup 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   31/10/2023 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [Kankariaankita@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 01-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Introduction- Menstrual Cup is a cost-effective ecofriendly convenient method of menstrual hygiene management but there is limited evidence of feasibility and acceptability of menstrual cups in India. 
Objective- To study the acceptability and safety of menstrual cup among married women aged 18-49 years in rural block of India.
Method- It is a three phase Pre and Post Intervention study in a rural block of north India. During Phase I baseline assessment will be done to study the background information, current practices of a menstrual management, expenditure on menstrual products and attitude towards using menstrual cups. In phase II in person training on menstrual cup will be provided by the study team and the content of the training will be anatomy of the reproductive tract composition of cup, methods of insertion removal and cleaning of the cup. After the training the appropriate size menstrual cup will be provided to the participants. Phase III includes the feasibility and acceptability of menstrual cup at one three and six months and one year post introduction of the menstrual cup. Pilot tested semi structured questionnaire will be used to assess the quantitative data for data collection. Chi square test/ Fischer test, independent samples student t- tests and Mann Whitney tests will be used for analysis of quantitative data using SPSS 21. An IDI/FGD Guide will be developed to capture the qualitative data. Thematic analysis will be done to analyze the quaIitative data using ATLAS.ti. 8 software.
Discussion- The findings from this study will help in assessing the facilitators and barriers about menstrual cups. These results can be used to plan a large multi centric study with a larger sample size in the future to assess the feasibility and acceptability of the menstrual cup.


 
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