Study About Patients Using Copper Intrauterine Device (IUD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Egymedicalpedia.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Egymedicalpedia
ClinicalTrials.gov Identifier:
NCT01541241
First received: February 14, 2012
Last updated: February 28, 2012
Last verified: February 2012
  Purpose

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
Copper Intrauterine Device Induced Bleeding

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Uterine Haemodynamic Changes in Patients With Copper Intrauterine Device Induced Bleeding

Resource links provided by NLM:


Further study details as provided by Egymedicalpedia:

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: May 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Egymedicalpedia
ClinicalTrials.gov Identifier: NCT01541241     History of Changes
Other Study ID Numbers: Ayman-1
Study First Received: February 14, 2012
Last Updated: February 28, 2012
Health Authority: Egypt: Ministry of Health and Population

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

ClinicalTrials.gov processed this record on October 20, 2014