ContraceptionNCT05263544
Uterine Anatomical Flexion Degree ( Uterocervical Angle) and Intrauterine Device (IUD) Dislocation
An observational study of Contraception and Intrauterine Device Dislocation, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Intrauterine Device Dislocation
- What is being tested?
- measuring uterocervical angle and uterine dimensions
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2021to 28 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: patients with and without intrauterine device displacement
Who may be able to join
- using intrauterine device
Who cannot join
- 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
Show all 9Show fewer
- History and/or presence of malignancy
- Pregnancy
- Menopause or premature ovarian failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training and Research Hospital
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- Contraception, Intrauterine Device Dislocation
- Being tested
- measuring uterocervical angle and uterine dimensions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring uterocervical angle and uterine dimensionsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with displaced IUD | Not described Receives: Other: measuring uterocervical angle and uterine dimensions | |
| Patients without displaced IUD | Not described Receives: Other: measuring uterocervical angle and uterine dimensions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of factors associated with intrauterine device dislocation.
Degree of uterocervical angle (°)will be measured and assessed for association with dislocation.
Measured: 6 months
Determination of factors associated with intrauterine device dislocation.
uterus size (mm) will be measured and assessed for association with dislocation.
Measured: 6 months
Determination of factors associated with intrauterine device dislocation.
uterine width (mm) will be measured and assessed for association with dislocation.
Measured: 6 months
Determination of factors associated with intrauterine device dislocation.
cervical canal length(mm) will be measured and assessed for association with dislocation.
Measured: 6 months
Determination of factors associated with intrauterine device dislocation.
endometrial canal length (mm) will be measured and assessed for association with dislocation.
Measured: 6 months
Determination of factors associated with intrauterine device dislocation.
endometrial canal width (mm) will be measured and assessed for association with dislocation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start30 Jun 2021
- Primary completion15 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma Ketenci Gencer, MD, Gaziosmanpasa Research and Education Hospital
- Investigators
- Fatma Ketenci Gencer, MD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263544
- Sponsor's protocol ID
- GaziosmanpasaTREHg
- Status last verified
- Jun 2023
- First submitted
- 3 Feb 2022
- Last updated
- 5 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Uterine Anatomical Flexion Degree ( Uterocervical Angle) in Cases With and Without Intrauterine Device (IUD) Dislocation
- ClinicalTrials.gov ID
- NCT05263544
- Acronym / sponsor ID
- GaziosmanpasaTREHg
- Conditions
- Contraception, Intrauterine Device Dislocation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with displaced IUD | – | Other: measuring uterocervical angle and uterine dimensions |
| Patients without displaced IUD | – | Other: measuring uterocervical angle and uterine dimensions |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients with and without intrauterine device displacement
Key inclusion criteria (1 listed)
- using intrauterine device
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measuring uterocervical angle and uterine dimensionsin 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 | Other | Patients with displaced IUD, Patients without displaced IUD |
Primary outcome
Determination of factors associated with intrauterine device dislocation.
Time frame: 6 months
Degree of uterocervical angle (°)will be measured and assessed for association with dislocation.
Determination of factors associated with intrauterine device dislocation.
Time frame: 6 months
uterus size (mm) will be measured and assessed for association with dislocation.
Determination of factors associated with intrauterine device dislocation.
Time frame: 6 months
uterine width (mm) will be measured and assessed for association with dislocation.
Determination of factors associated with intrauterine device dislocation.
Time frame: 6 months
cervical canal length(mm) will be measured and assessed for association with dislocation.
Determination of factors associated with intrauterine device dislocation.
Time frame: 6 months
endometrial canal length (mm) will be measured and assessed for association with dislocation.
Determination of factors associated with intrauterine device dislocation.
Time frame: 6 months
endometrial canal width (mm) will be measured and assessed for association with dislocation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Ketenci Gencer, MD principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception and Intrauterine Device Dislocation, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of factors associated with intrauterine device dislocation. (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.