Uterine Anatomical Flexion Degree ( Uterocervical Angle) and Intrauterine Device (IUD) Dislocation

Evaluation of Uterine Anatomical Flexion Degree ( Uterocervical Angle) in Cases With and Without Intrauterine Device (IUD) Dislocation

Investigators want to find numerical determination of the degree of anatomical anterior or posterior flexion of the uterus (uterocervical angle) at the intersection of both lines using a protractor, provided that straight lines are drawn from the middle of the cervical canal and the middle of the endometrial canal in cases where the intrauterine device is found to have dislocated and and cases with no dislocation. Investigators will also measure uterus size, uterine width, cervical canal length, endometrial canal length, endometrial canal width and compare the results in both groups.

Study Overview

• Status: Completed
• Conditions: Contraception; Intrauterine Device Dislocation
• Intervention / Treatment: Other: measuring uterocervical angle and uterine dimensions

Detailed Description

IUD (intrauterine device) is one of the most preferred birth control methods in our country and in the world, and this usage rate is approximately 23% in the world. In our country, this rate is around 17%. The high chance of success, ease of use and long-term effectiveness can be counted among the reasons for preference.Currently used IUD is a 'T' shaped, has a 380 mm copper surface and its arms open at the widest part of the endometrium (TCu380A), thereby preventing it from slipping back. Undesirable effects include pelvic pain, dysmenorrhea, heavy menstrual bleeding, malposition/dislocation. Malposition/dislocation occurs in approximately 10% of patients. Malposition/dislocation of the IUD may be associated with excessive menstrual bleeding, or the IUD may be displaced without any symptoms. Malposition/dislocation can be classified as expulsion, burial, displacement, or perforation. Expulsion is defined as partial or complete protrusion of the cervical canal, and displacement is defined as rotation of the IUD or its displacement towards the lower segments. At the same time, IUD may be embedded in the myometrium to such an extent that it does not reach the serosa of the myometrium, while it may puncture the serosa and cause perforation may occur. TCu380A devices have a 6% risk of expulsion in the first 1 year. Displacement or slippage of the IUD reduces the effectiveness of the IUD and may cause expulsion. Therefore, being able to predict that the IUD will not slip is very important in terms of preventing unwanted pregnancies. In our study, in both groups with and without displaced IUD, uterus size, uterine width, cervical canal length, endometrial canal length, endometrial canal width, and the angle at the intersection of the imaginary lines corresponding to the middle of the endometrium and cervical canal, which can be detected by transvaginal ultrasound were measured. Investigators aimed to determine the measurements and compare the obtained data to find associated factors related to dislocation.

• Study Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

• Study Contact: Name: Fatma Ketenci Gencer, MD; Phone Number: +905416116469; Email: fathma_k@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Gaziosmanpasa Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

patients with and without intrauterine device displacement

Description

Inclusion Criteria:

• using intrauterine device

Exclusion Criteria:

• Pelvic mass that cannot be differentially diagnosed by physical examination and imaging techniques
• Having an indication for surgical treatment
• Presence of space-occupying polyp or fibroid affecting the anatomy of the endometrium
• Presence of myoma or adenomyosis that disrupts the integrity of the myometrium
• Presence of pelvic infection
• Currently using any hormonal therapy
• History and/or presence of malignancy
• Pregnancy
• Menopause or premature ovarian failure

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with displaced IUD	Other: measuring uterocervical angle and uterine dimensions; in both groups with and without displaced IUD, uterus size, uterine width, cervical canal length, endometrial canal length, endometrial canal width, and the angle at the intersection of the imaginary lines corresponding to the middle of the endometrium and cervical canal, which can be detected by transvaginal ultrasound will be measured
Patients without displaced IUD	Other: measuring uterocervical angle and uterine dimensions; in both groups with and without displaced IUD, uterus size, uterine width, cervical canal length, endometrial canal length, endometrial canal width, and the angle at the intersection of the imaginary lines corresponding to the middle of the endometrium and cervical canal, which can be detected by transvaginal ultrasound will be measured

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of factors associated with intrauterine device dislocation.	Degree of uterocervical angle (°)will be measured and assessed for association with dislocation.	6 months
Determination of factors associated with intrauterine device dislocation.	uterus size (mm) will be measured and assessed for association with dislocation.	6 months
Determination of factors associated with intrauterine device dislocation.	uterine width (mm) will be measured and assessed for association with dislocation.	6 months
Determination of factors associated with intrauterine device dislocation.	cervical canal length(mm) will be measured and assessed for association with dislocation.	6 months
Determination of factors associated with intrauterine device dislocation.	endometrial canal length (mm) will be measured and assessed for association with dislocation.	6 months
Determination of factors associated with intrauterine device dislocation.	endometrial canal width (mm) will be measured and assessed for association with dislocation.	6 months

Collaborators and Investigators

• Sponsor: Gaziosmanpasa Research and Education Hospital
• Investigators: Principal Investigator: Fatma Ketenci Gencer, MD, Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 27, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations
• Other Study ID Numbers: GaziosmanpasaTREHg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No