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

NCT03261804 | Completed

• 1 other identifier: VD in IUD users
• Study Type: observational
• Target: 604
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vaginal Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group I:internal vaginal douching users

Behavioral: relation between vaginal douching and vaginal infection

Group II: none internal vaginal douching users

Behavioral: relation between vaginal douching and vaginal infection

Interventions

relation between vaginal douching and vaginal infection BEHAVIORAL

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 I:internal vaginal douching users; Group II: none internal vaginal douching users

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Family planning and population growth problems

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women's Health Hospital, Assiut University

Asyut, 71515, Egypt

Location

Related Publications (10)

• 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: 12954522 RESULT

• 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: 12762087 RESULT

• 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: 9240115 RESULT

• 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: 15458898 RESULT

• 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: 17413534 RESULT

• 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: 20500937 RESULT

• 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: 11463927 RESULT

• 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: 19553425 RESULT

• 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: 17972087 RESULT

• 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.

  PMID: 3447813 RESULT

MeSH Terms

Conditions

Vaginitis

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ahmed A YOUSSEF, M.D

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynaecology, Women Health Hospitals, Assiut University

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 25, 2017
• Study Start: June 1, 2018
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

EG (1)