跳至主要内容
临床试验/CTRI/2022/01/039237
CTRI/2022/01/039237招募中不适用

Acceptability and Performance of menstrual cup versus conventional methods for menstrual hygiene in Reproductive Age Group women in selected states in India

She Cup agency MediAseso Pvt Ltd3 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年7月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
180
试验地点
3
主要终点
Acceptability and performance of a menstrual cup to manage the periods

研究概览

简要总结

A menstrual cup is a type of feminine hygiene product it’s made up of health grade silicon shaped like a bell, flexible, which is non-toxic and non-allergic worn inside the vagina to catch the menstrual blood About every 4–12 hours (depending on the amount of flow), the menstruating woman removes the menstrual cup from her vagina empties the collected menstrual blood into a toilet or sink, washes the cup under running water and inserts it again. At the end of the monthly period, the cup can be sterilized, usually by boiling in water. Unlike tampons and pads the menstrual cup collects menstrual fluid rather than absorbing it. A menstrual cup is a nonabsorbent reusable cup that collects menstrual blood.

In present scenario women and girls of a developing country like India instead of the availability of various other alternatives still lacking sufficient knowledge and practice related to proper menstrual hygiene.

The study aims to improve the quality of life of women by introducing them all the benefits of a menstrual cup as -

Economical – It’s affordable simply due to reusability. Women spend money buying pads and tampons. Girls can use up to 15,000 hygiene products in their lifetime while they only need to use five or six vaginal cups since they are reusable for up to ten years – which means fewer trips to the pharmacy store.

Environment-friendly and Hassle-free waste disposal – According to the environmentalist, using sanitary pads and tampons is a big threat to the environment from raw materials to processing and production. Based on research, the tampons are made up of cotton fibre, and it takes six months to bio grade, which is hazardous for the environment.

Maintain vaginal pH and aids in minimal bacterial growth- As pad contains harmful chemicals and it makes the soft vaginal area more prone to infection by absorbing the normal moisture and allowing bacteria to enter and accumulate. Even though the condition makes the female believe that it’s common to experience allergies and itchiness in the vagina during menstruation which is actually not. The cups can be easily emptied when it’s full and with minimal or almost no presence of bacteria since it can be sterilized after any use.

Accessible and convenient – The cup is made up of silicon and rubber, designed to be flexible, soft edges and are flexible for quick and easy insertion though the pads are easy to place but the associated risks are much more.

Inodorous –Using of the scented hygiene products is discouraged by medical experts because the added chemicals cause irritation and further vaginal infections due to reaction between expelled blood, preservative gel present in pads and the environment of vaginal flora. So with cups, there is no need to be too conscious about unpleasant mensuration odour since there is very less exposure of the fluid to the air.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
15.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • The reproductive age group of women of 15 to 50 years (however the inclusion criteria is participants with menstrual phase).

排除标准

  • Women with known silicon allergy, uterovaginal infection or fistula, pregnant or intendant to become pregnant.

结局指标

主要结局

Acceptability and performance of a menstrual cup to manage the periods

时间窗: Three months

次要结局

  • Quality of life, comfort, physical activities during menstruation(three months)

研究者

发起方
She Cup agency MediAseso Pvt Ltd
申办方类型
Pharmaceutical industry-Indian

研究点 (3)

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