Vaginal Infection Clinical Trial
Official title:
Relation Between Internal Vaginal Douching and Vaginal Infections in Intrauterine Contraceptive Device Users
NCT number | NCT03261804 |
Other study ID # | VD in IUD users |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | August 1, 2021 |
Verified date | May 2022 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To determine the effect of performing internal vaginal douching on the frequency and severity and type of vaginal infections in IUD users
Status | Completed |
Enrollment | 604 |
Est. completion date | August 1, 2021 |
Est. primary completion date | August 1, 2021 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 48 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Women's Health Hospital, Assiut University | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Ferraz do Lago R, Simões 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. — View 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. — View 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. — View 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. — View 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. Epub 2007 Oct 31. — View Citation
Luong ML, Libman M, Dahhou M, Chen MF, Kahn SR, Goulet L, Séguin 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)3 — View Citation
Martino JL, Vermund SH. Vaginal douching: evidence for risks or benefits to women's health. Epidemiol Rev. 2002;24(2):109-24. Review. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | frequency of vaginal infections in IUD user | Compare frequency of vaginal infections in IUD user who perform internal vaginal douching with not perform internal vaginal douching | 18 months |
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