Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03261804
Recruitment Status : Not yet recruiting
First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Alaaeldin Mahmoud Youssef, 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

Condition or disease Intervention/treatment
Vaginal Infection Behavioral: relation between vaginal douching and vaginal infection

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 608 participants
Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Relation Between Internal Vaginal Douching and Vaginal Infections in Intrauterine Contraceptive Device Users
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : December 30, 2018

Group/Cohort Intervention/treatment
Group I:internal vaginal douching users Behavioral: relation between vaginal douching and vaginal infection
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 Behavioral: relation between vaginal douching and vaginal infection
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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Family planning and population growth problems
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261804


Contacts
Layout table for location contacts
Contact: AHMED A YOUSSEF, MD 01006184921 Ahmedalaa11282@yahoo.com
Contact: OMAR M SHABAAN, MD 01223971457 Omshaaban2000@yahoo.com

Sponsors and Collaborators
Assiut University

Publications of Results:

Layout table for additonal information
Responsible Party: Ahmed Mohamed Alaaeldin Mahmoud Youssef, Lecturer of Obstetrics and Gynaecology, Women Health Hospitals, Assiut University, Assiut University
ClinicalTrials.gov Identifier: NCT03261804     History of Changes
Other Study ID Numbers: VD in IUD users
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs