<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03261804</url>
  </required_header>
  <id_info>
    <org_study_id>VD in IUD users</org_study_id>
    <nct_id>NCT03261804</nct_id>
  </id_info>
  <brief_title>Relation Between Internal Vaginal Douching and Vaginal Infections in Intrauterine Contraceptive Device Users</brief_title>
  <official_title>Relation Between Internal Vaginal Douching and Vaginal Infections in Intrauterine Contraceptive Device Users</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the effect of performing internal vaginal douching on the frequency and severity&#xD;
      and type of vaginal infections in IUD users&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The actual frequency of infectious vaginitis is difficult to determine, due to numerous&#xD;
      confounding factors, such as a high asymptomatic rate, inaccurate self-diagnosis and&#xD;
      treatment, and population dependence. In the USA, the prevalence of cervicovaginal infections&#xD;
      was 29.1% and that bacterial vaginosis was frequently found 19.7% among IUDs users 6 months&#xD;
      after insertion.&#xD;
&#xD;
      Vaginal douching (VD) is the process of intravaginal cleansing with any type of liquid&#xD;
      solution. Douching is a common practice among women all over the world and is used for&#xD;
      personal hygiene. Studies in the USA showed that about 37% of US women in reproductive age&#xD;
      (15-44 Y) reported regular VD. The performance of this habit varied between different ethnic&#xD;
      groups and different socioeconomic levels. In a Turkish study, VD reported to be performed by&#xD;
      91.6% of women living in rural areas.&#xD;
&#xD;
      There are cultural believes that VD is necessary for good hygiene. Other motives for douching&#xD;
      are to clean the vagina after the end of menses or before and/or after sexual intercourse, to&#xD;
      prevent or ameliorate an odor, to prevent or treat vaginal symptoms such as itching and&#xD;
      discharge. Other factors contribute to a woman's decision to douche her vagina like the&#xD;
      influence of patients' mothers, friends, and relatives. Some others consider VD as religious&#xD;
      duty to be able to pray after menses or sexual intercourse.&#xD;
&#xD;
      Previous studies have pointed to reproductive health hazards of VD. Women who perform this&#xD;
      habit were 1.2 to 5.1 times more likely to develop bacterial vaginosis (BV); 1.6 -1.9 times&#xD;
      more likely to experience a preterm labor (PTL). Women who adopt this habit were twice likely&#xD;
      to develop cancer cervix; 1.7 times more likely to have sexually transmitted infections&#xD;
      (STIs). Moreover, VD performers have 73% increased risk of pelvic inflammatory disease (PID)&#xD;
      and are 1.5 times more likely to develop endometritis.&#xD;
&#xD;
      The intrauterine device (IUD) is the most widely used method of contraception because of its&#xD;
      safety and cost-effective benefit. Over 100 million women are now using this device. However,&#xD;
      the number of user is still much less than expected. This probably due to the doubt about&#xD;
      complications from IUD, the most common medical reasons for early discontinuation of IUD are&#xD;
      bleeding and/or pain along with genital infections.&#xD;
&#xD;
      Many women who have vaginitis generally complain of some combination of discharge, odor,&#xD;
      irritation, and itch. The most common causes of vaginitis in premenopausal group were&#xD;
      bacterial vaginosis, vaginal candidiasis and trichomoniasis. Previous studies showed that&#xD;
      copper IUD caused a change in the cervicovaginal flora that resulted in the predominance of&#xD;
      anaerobic species. These alterations may affect vaginal health and cause more vaginal&#xD;
      infection and symptoms for example itching, soreness and abnormal discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">August 1, 2021</completion_date>
  <primary_completion_date type="Actual">August 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Family-Based</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>frequency of vaginal infections in IUD user</measure>
    <time_frame>18 months</time_frame>
    <description>Compare frequency of vaginal infections in IUD user who perform internal vaginal douching with not perform internal vaginal douching</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">604</enrollment>
  <condition>Vaginal Infection</condition>
  <arm_group>
    <arm_group_label>Group I:internal vaginal douching users</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II: none internal vaginal douching users</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>relation between vaginal douching and vaginal infection</intervention_name>
    <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.</description>
    <arm_group_label>Group I:internal vaginal douching users</arm_group_label>
    <arm_group_label>Group II: none internal vaginal douching users</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Family planning and population growth problems&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1- Women currently using cu IUD for at least 6 months before the study 2-Within the&#xD;
             age 18-48 years 3-Accept to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1-Woman who are using a contraceptive method other than IUD 2-Any other endocrinal&#xD;
             disease like DM , thyroid ……etc 3- Patient under chemotherapy for treatment of cancer&#xD;
             4- antibiotic and Steroid users 5-inperfect IUD place&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Ahmed A YOUSSEF, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Women's Health Hospital, Assiut University</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>12954522</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>12762087</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>9240115</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>15458898</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>17413534</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>20500937</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>11463927</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>19553425</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>17972087</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>3447813</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>May 19, 2022</last_update_submitted>
  <last_update_submitted_qc>May 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Mohamed Alaaeldin Mahmoud Youssef</investigator_full_name>
    <investigator_title>Lecturer of Obstetrics and Gynaecology, Women Health Hospitals, Assiut University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03261804
org study id: VD in IUD users
nct id: NCT03261804
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To determine the effect of performing internal vaginal douching on the frequency and severity
      and type of vaginal infections in IUD users
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.
observational model: Family-Based
time perspective: Cross-Sectional
measure: frequency of vaginal infections in IUD user
time frame: 18 months
description: Compare frequency of vaginal infections in IUD user who perform internal vaginal douching with not perform internal vaginal douching
arm group label: Group I:internal vaginal douching users
arm group label: Group II: none internal vaginal douching users
intervention type: Behavioral
intervention name: relation between vaginal douching and vaginal infection
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.
arm group label: Group I:internal vaginal douching users
arm group label: Group II: none internal vaginal douching users
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 48 Years
last name: Ahmed A YOUSSEF, M.D
role: Principal Investigator
affiliation: Assiut University
facility: 
country: Egypt
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: 12954522
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: 12762087
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: 9240115
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: 15458898
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: 17413534
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: 20500937
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: 11463927
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: 19553425
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: 17972087
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.
PMID: 3447813
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Mohamed Alaaeldin Mahmoud Youssef
investigator title: Lecturer of Obstetrics and Gynaecology, Women Health Hospitals, Assiut University
mesh term: Infections
mesh term: Communicable Diseases