Use Sonography in Patients With Intrauterine Device Presenting With Bleeding

May 3, 2017 updated by: ESShafeek, Assiut University

Intrauterine Contraceptive Device:Clinical and Sonographic Correlation in Patients Presenting With Bleeding

Intrauterine contraceptive device is one of the most efficient and reversible methods of birth control with low cost and long duration of use However, in the first year after insertion, between 5 and 15% of women will have their Intrauterine contraceptive device removed because of irregular uterine bleeding which have been attributed to the effect of contact between the device and the endometrium and even the pressure on the uterine muscle . The disharmonious relationship between the Intrauterine contraceptive device and the uterus is the cause of most of the bleeding complaints, so bleeding is related to improper position rather than the contraceptive method itself which should be excluded before abandoning the Intrauterine contraceptive device for any other method of birth control

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

patients using intrauterine contraceptive device complaining of bleeding

Description

Inclusion Criteria:

patients using intrauterine contraceptive device complaining of bleeding

Exclusion Criteria:

  • a-Associated uterine, cervical,or adenexal pathology b-Associated pelvic infection c-Generalized bleeding disorders d-Medications causing coagulation defects e-Medical disorders causing bleeding e.g hypertention f-Endocrine disorder as thyroid dysfunction g-Who refuse to share in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The intrauterine device-Endometrial distance
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2017

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

May 3, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (Actual)

May 4, 2017

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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