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Study About Patients Using Copper Intrauterine Device (IUD)

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ClinicalTrials.gov Identifier: NCT01541241
Recruitment Status : Unknown
Verified February 2012 by Egymedicalpedia.
Recruitment status was:  Recruiting
First Posted : February 29, 2012
Last Update Posted : February 29, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
THE AIM OF THE this study is to assess the hemodynamic changes of uterine artery in patients with CIUD induced bleeding by using transvaginal color Doppler indices (uterine artery resistance index and pulsatility index) to prove the relationship between these changes and bleeding in these patient .

Condition or disease
Copper Intrauterine Device Induced Bleeding

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Uterine Haemodynamic Changes in Patients With Copper Intrauterine Device Induced Bleeding
Study Start Date : January 2012
Primary Completion Date : January 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
copper IUD used

Group I: includes 50 cases using CIUD and complaining of menorrhagia or menometrorrhagia.

Group II: includes 50 cases using CIUD and not complaining of abnormal uterine bleeding.



Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
primary care clinic, hospital out patient clinic
Criteria

Inclusion Criteria:

  1. Regularly menstruating women before CIUD insertion.
  2. Age between 18 and 35 years.
  3. Hormonal treatment has not been taken at least two months before the study.
  4. Non steroidal anti-inflammatory drugs has not been taken 24 hours before the examination.

Exclusion Criteria:

  1. Pregnancy.
  2. The presence of pelvic pathology as ovarian cysts, pelvic endometriosis, endometrial polyps or fibrosis.
  3. Present or past history of pelvic inflammatory disease.
  4. Patients on hormonal treatment in the last two months before the study.
  5. Patients on non steroidal anti-inflammatory drugs last 24 hours before the examination.
Contacts and Locations

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): NCT01541241


Contacts
Contact: Mohamed SE Elsafty, lecturer 01003922211 ext 002
Contact: Mohamed Elmandouh Mohamed, ass proff

Locations
Egypt
Shoubra Maternity Hospital Recruiting
Cairo, Shoubra, Egypt
Contact: Ayman Abdelazeem elgamal, Resident    010003385499 ext 002      
Contact: Mohamed SE Elsafty, Lecture    01003922211 ext 002      
Principal Investigator: Ayman Abdelazim Elgamal, resident         
Sponsors and Collaborators
Egymedicalpedia
Investigators
Principal Investigator: Ayman Abdelazim Elgamal, Residant Shoubra General Hospital
More Information

Responsible Party: Egymedicalpedia
ClinicalTrials.gov Identifier: NCT01541241     History of Changes
Other Study ID Numbers: Ayman-1
First Posted: February 29, 2012    Key Record Dates
Last Update Posted: February 29, 2012
Last Verified: February 2012

Keywords provided by Egymedicalpedia:
Intrauterine contraceptive device (IUD) is one of the most frequently used methods of birth control around the world
Uterine Hemodynamic changes

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Copper
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs