Relation Between Internal Vaginal Douching and Vaginal Infections in Intrauterine Contraceptive Device Users

May 19, 2022 updated by: Ahmed Mohamed Alaaeldin Mahmoud Youssef, Assiut University
To determine the effect of performing internal vaginal douching on the frequency and severity and type of vaginal infections in IUD users

Study Overview

Detailed Description

The actual frequency of infectious vaginitis is difficult to determine, due to numerous confounding factors, such as a high asymptomatic rate, inaccurate self-diagnosis and treatment, and population dependence. In the USA, the prevalence of cervicovaginal infections was 29.1% and that bacterial vaginosis was frequently found 19.7% among IUDs users 6 months after insertion.

Vaginal douching (VD) is the process of intravaginal cleansing with any type of liquid solution. Douching is a common practice among women all over the world and is used for personal hygiene. Studies in the USA showed that about 37% of US women in reproductive age (15-44 Y) reported regular VD. The performance of this habit varied between different ethnic groups and different socioeconomic levels. In a Turkish study, VD reported to be performed by 91.6% of women living in rural areas.

There are cultural believes that VD is necessary for good hygiene. Other motives for douching are to clean the vagina after the end of menses or before and/or after sexual intercourse, to prevent or ameliorate an odor, to prevent or treat vaginal symptoms such as itching and discharge. Other factors contribute to a woman's decision to douche her vagina like the influence of patients' mothers, friends, and relatives. Some others consider VD as religious duty to be able to pray after menses or sexual intercourse.

Previous studies have pointed to reproductive health hazards of VD. Women who perform this habit were 1.2 to 5.1 times more likely to develop bacterial vaginosis (BV); 1.6 -1.9 times more likely to experience a preterm labor (PTL). Women who adopt this habit were twice likely to develop cancer cervix; 1.7 times more likely to have sexually transmitted infections (STIs). Moreover, VD performers have 73% increased risk of pelvic inflammatory disease (PID) and are 1.5 times more likely to develop endometritis.

The intrauterine device (IUD) is the most widely used method of contraception because of its safety and cost-effective benefit. Over 100 million women are now using this device. However, the number of user is still much less than expected. This probably due to the doubt about complications from IUD, the most common medical reasons for early discontinuation of IUD are bleeding and/or pain along with genital infections.

Many women who have vaginitis generally complain of some combination of discharge, odor, irritation, and itch. The most common causes of vaginitis in premenopausal group were bacterial vaginosis, vaginal candidiasis and trichomoniasis. Previous studies showed that copper IUD caused a change in the cervicovaginal flora that resulted in the predominance of anaerobic species. These alterations may affect vaginal health and cause more vaginal infection and symptoms for example itching, soreness and abnormal discharge.

Study Type

Observational

Enrollment (Actual)

604

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Assiut, Egypt, 71515
        • Women's Health Hospital, Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Family planning and population growth problems

Description

Inclusion Criteria:

  • 1- Women currently using cu IUD for at least 6 months before the study 2-Within the age 18-48 years 3-Accept to participate in the study

Exclusion Criteria:

  • 1-Woman who are using a contraceptive method other than IUD 2-Any other endocrinal disease like DM , thyroid ……etc 3- Patient under chemotherapy for treatment of cancer 4- antibiotic and Steroid users 5-inperfect IUD place

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Family-Based
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I:internal vaginal douching users
personal hygiene including performing external or Internal vaginal douching, how she is performing this douching (by hand, water, jet, pump), how frequent and why they perform this internal vaginal douche.
Group II: none internal vaginal douching users
personal hygiene including performing external or Internal vaginal douching, how she is performing this douching (by hand, water, jet, pump), how frequent and why they perform this internal vaginal douche.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency of vaginal infections in IUD user
Time Frame: 18 months
Compare frequency of vaginal infections in IUD user who perform internal vaginal douching with not perform internal vaginal douching
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ahmed A YOUSSEF, M.D, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

August 23, 2017

First Submitted That Met QC Criteria

August 24, 2017

First Posted (Actual)

August 25, 2017

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • VD in IUD users

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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