Clinical trial NCT05263544: Uterine Anatomical Flexion Degree ( Uterocervical Angle) and Intrauterine Device (IUD) Dislocation
Official title: Evaluation of Uterine Anatomical Flexion Degree ( Uterocervical Angle) in Cases With and Without Intrauterine Device (IUD) Dislocation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Intrauterine Device Dislocation
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2022-03-02
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with and without intrauterine device displacement

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determination of factors associated with intrauterine device dislocation.
timeFrame: 6 months
measure: Determination of factors associated with intrauterine device dislocation.
timeFrame: 6 months
measure: Determination of factors associated with intrauterine device dislocation.
timeFrame: 6 months
measure: Determination of factors associated with intrauterine device dislocation.
timeFrame: 6 months
measure: Determination of factors associated with intrauterine device dislocation.
timeFrame: 6 months
measure: Determination of factors associated with intrauterine device dislocation.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Training and Research Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Fatma Ketenci Gencer, MD
role: PRINCIPAL_INVESTIGATOR
References: