Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-05 @ 5:45 PM
Study NCT ID:
NCT03261804
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2017-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relation Between Internal Vaginal Douching and Vaginal Infections in Intrauterine Contraceptive Device Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014627', 'term': 'Vaginitis'}], 'ancestors': [{'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 604}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-19', 'studyFirstSubmitDate': '2017-08-23', 'studyFirstSubmitQcDate': '2017-08-24', 'lastUpdatePostDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'frequency of vaginal infections in IUD user', 'timeFrame': '18 months', 'description': 'Compare frequency of vaginal infections in IUD user who perform internal vaginal douching with not perform internal vaginal douching'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal Infection']}, 'referencesModule': {'references': [{'pmid': '12954522', 'type': 'RESULT', 'citation': 'Ferraz do Lago R, Simoes JA, Bahamondes L, Camargo RP, Perrotti M, Monteiro I. Follow-up of users of intrauterine device with and without bacterial vaginosis and other cervicovaginal infections. Contraception. 2003 Aug;68(2):105-9. doi: 10.1016/s0010-7824(03)00109-4.'}, {'pmid': '12762087', 'type': 'RESULT', 'citation': "Martino JL, Vermund SH. Vaginal douching: evidence for risks or benefits to women's health. Epidemiol Rev. 2002;24(2):109-24. doi: 10.1093/epirev/mxf004. No abstract available."}, {'pmid': '9240115', 'type': 'RESULT', 'citation': 'Zhang J, Thomas AG, Leybovich E. Vaginal douching and adverse health effects: a meta-analysis. Am J Public Health. 1997 Jul;87(7):1207-11. doi: 10.2105/ajph.87.7.1207.'}, {'pmid': '15458898', 'type': 'RESULT', 'citation': 'Zhang J, Hatch M, Zhang D, Shulman J, Harville E, Thomas AG. Frequency of douching and risk of bacterial vaginosis in African-American women. Obstet Gynecol. 2004 Oct;104(4):756-60. doi: 10.1097/01.AOG.0000139947.90826.98.'}, {'pmid': '17413534', 'type': 'RESULT', 'citation': 'Hutchinson KB, Kip KE, Ness RB; Gynecologic Infection Follow-Through (GIFT) Investigators. Vaginal douching and development of bacterial vaginosis among women with normal and abnormal vaginal microflora. Sex Transm Dis. 2007 Sep;34(9):671-5. doi: 10.1097/01.olq.0000258435.34879.da.'}, {'pmid': '20500937', 'type': 'RESULT', 'citation': 'Luong ML, Libman M, Dahhou M, Chen MF, Kahn SR, Goulet L, Seguin L, Lydon J, McNamara H, Platt RW, Kramer MS. Vaginal douching, bacterial vaginosis, and spontaneous preterm birth. J Obstet Gynaecol Can. 2010 Apr;32(4):313-320. doi: 10.1016/S1701-2163(16)34474-7.'}, {'pmid': '11463927', 'type': 'RESULT', 'citation': 'Fonck K, Kaul R, Keli F, Bwayo JJ, Ngugi EN, Moses S, Temmerman M. Sexually transmitted infections and vaginal douching in a population of female sex workers in Nairobi, Kenya. Sex Transm Infect. 2001 Aug;77(4):271-5. doi: 10.1136/sti.77.4.271.'}, {'pmid': '19553425', 'type': 'RESULT', 'citation': 'Rew L. Vaginal douching increased risk of sexually transmitted infections in high-risk adolescents. Evid Based Nurs. 2009 Jul;12(3):88. doi: 10.1136/ebn.12.3.88. No abstract available.'}, {'pmid': '17972087', 'type': 'RESULT', 'citation': 'Kanat-Pektas M, Ozat M, Gungor T. The effects of TCu-380A on cervicovaginal flora. Arch Gynecol Obstet. 2008 May;277(5):429-32. doi: 10.1007/s00404-007-0496-0. Epub 2007 Oct 31.'}, {'pmid': '3447813', 'type': 'RESULT', 'citation': 'Haukkamaa M, Stranden P, Jousimies-Somer H, Siitonen A. Bacterial flora of the cervix in women using an intrauterine device. Contraception. 1987 Nov;36(5):527-34. doi: 10.1016/0010-7824(87)90004-7.'}]}, 'descriptionModule': {'briefSummary': 'To determine the effect of performing internal vaginal douching on the frequency and severity and type of vaginal infections in IUD users', 'detailedDescription': "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.\n\nVaginal 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.\n\nThere 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.\n\nPrevious 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.\n\nThe 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.\n\nMany 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Family planning and population growth problems', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT03261804', 'briefTitle': 'Relation Between Internal Vaginal Douching and Vaginal Infections in Intrauterine Contraceptive Device Users', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Relation Between Internal Vaginal Douching and Vaginal Infections in Intrauterine Contraceptive Device Users', 'orgStudyIdInfo': {'id': 'VD in IUD users'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I:internal vaginal douching users', 'interventionNames': ['Behavioral: relation between vaginal douching and vaginal infection']}, {'label': 'Group II: none internal vaginal douching users', 'interventionNames': ['Behavioral: relation between vaginal douching and vaginal infection']}], 'interventions': [{'name': 'relation between vaginal douching and vaginal infection', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Group I:internal vaginal douching users', 'Group II: none internal vaginal douching users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'facility': "Women's Health Hospital, Assiut University", 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Ahmed A YOUSSEF, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obstetrics and Gynaecology, Women Health Hospitals, Assiut University', 'investigatorFullName': 'Ahmed Mohamed Alaaeldin Mahmoud Youssef', 'investigatorAffiliation': 'Assiut University'}}}}