Can Uterocervical Angle Predict the Displacement of Copper Intrauterine Devices (T-Cu 380A)

NCT05556421 | Completed

• 1 other identifier: KanuniSSEAH2
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators conducted a case-control study between December 2020-June 2021 at Istanbul Health Sciences University Kanuni Sultan Suleyman Training and Research Hospital family planning outpatient clinics. One hundred and forty-three patients who had copper intrauterine devices (T Cu 380 A) inserted for contraception were evaluated between the 6th week to 5 years after insertion. Patients were divided into two groups according to their ultrasonographic examinations as "displaced" or "normal" positions. Uterocervical angles were measured of both groups by transvaginal ultrasonography and investigated whether the uterocervical angle had any effect in predicting the displacement of copper intrauterine devices.

Conditions

Intrauterine Device

Keywords

displacement; contraception; family planning; T-Cu 380A; uterocervical angle

Outcome Measures

Primary Outcomes (1)

• uterocervical angle

  Uterocervical angle (UCA) is the angle measured in the triangle region between the anterior uterine segment and the cervical canal

  6 months

Secondary Outcomes (2)

• uterine volume

  6 months

• endometrial cavity length

  6 months

Study Arms (2)

case group

dislocated intrauterine device

Diagnostic Test: uterocervical angle

control group

normal intrauterine device position

Diagnostic Test: uterocervical angle

Interventions

uterocervical angle DIAGNOSTIC_TEST

uterocervical angles were measured for both groups by transvaginal ultrasonography and investigated whether the uterocervical angle had any effect in predicting the displacement of copper intrauterine devices.

case group; control group

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The female patients between the ages of 21-45 who applied to either gynecology or family planning outpatient clinics and who had been using copper IUD (T Cu 380-A) as a contraception method for the last 6 weeks to 5 years were included in the study. Patients were included in the study on a voluntary basis.

You may qualify if:

• Patients aged between 21-45

You may not qualify if:

• Patients under the age of twenty-one and over the age of 45
• Patients applied to the hospital within the first 6 weeks after copper IUD insertion
• Patients with Space-occupying lesions (polyp, fibroid) in the uterine cavity
• Patients who have and/or had a pelvic inflammatory disease
• Patients who had Ascus, Hgsil, Lgsil, CIN (1,2,3), carcinoma in situ, and malignancy in their smear results before the study started or detected during the study period, and patients who were done LEEP or conization procedures due to these pathologies.
• Patients with Descensus uteri
• Patients with cervical polyps
• Patients with connective tissue disease I- Patients with uterine myomas or adenomyosis
• Patients with uterine anomaly
• Patients with vaginal infection or recurrent vaginitis and patients with abnormal uterine bleeding
• l- Patients with immune-compromised situations such as AIDS, drug use, or cortisone treatment m- Patients using anticoagulants for any reason n- Patients who have known Copper allergy or rare Copper metabolism disease (Wilson disease)

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Istanbul, 34307, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: January 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: September 12, 2025

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)