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

Completed

• Conditions: Vaginal Infection
• Interventions: Behavioral: relation between vaginal douching and vaginal infection

• Registration Number: NCT03261804
• Lead Sponsor: Assiut University

Brief Summary

To determine the effect of performing internal vaginal douching on the frequency and severity and type of vaginal infections in IUD users

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 Timeline

• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-24
• Study First Posted: 2017-08-25
• Study Start: 2018-06-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 604

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group I:internal vaginal douching users	relation between vaginal douching and vaginal infection	-
Group II: none internal vaginal douching users	relation between vaginal douching and vaginal infection	-

Primary Outcome Measures

Name	Time	Method
frequency of vaginal infections in IUD user	18 months	Compare frequency of vaginal infections in IUD user who perform internal vaginal douching with not perform internal vaginal douching

Trial Locations

Locations (1)

Women's Health Hospital, Assiut University; 🇪🇬 Assiut, Egypt