Clinical trial NCT05556421: Can Uterocervical Angle Predict the Displacement of Copper Intrauterine Devices (T-Cu 380A)
Official title: Can Uterocervical Angle Predict the Displacement of Copper Intrauterine Devices (T-Cu 380A)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrauterine Device
Keywords: displacement
contraception
family planning
T-Cu 380A
uterocervical angle
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 123
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: We 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.

Detailed description: Family planning contains various protection methods, and copper intrauterine devices (IUD) are one of these. It has come forward among the contraception methods due to its long-acting effect, rapid return of fertility when discontinued, and ease of use. In worldwide usage, IUDs are the third most common method of contraception after tubal ligation and male condoms (1). When long-acting contraception methods were compared, the failure rate of the IUD was 0.8% per 100 women within one year (2). Factors affecting failure were; the application time of IUDs (3), application technique (4), uterus dimensions (5), endometrial cavity length (6), parity (7), and mode of delivery (8).

Uterocervical angle (UCA) is the angle measured in the triangle region between the anterior uterine segment and the cervical canal (9). UCA has been evaluated to predict the threat of preterm birth in national and international studies (9,10). In the literature, UCA has not been used in any studies within the scope of family planning. Our study aimed to investigate the feasibility of uterocervical angle measurements in predicting the dislocation of IUDs.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 21-45

Exclusion Criteria:

1. Patients under the age of twenty-one and over the age of 45
2. Patients applied to the hospital within the first 6 weeks after copper IUD insertion
3. Patients with Space-occupying lesions (polyp, fibroid) in the uterine cavity
4. Patients who have and/or had a pelvic inflammatory disease
5. 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.
6. Patients with Descensus uteri
7. Patients with cervical polyps
8. Patients with connective tissue disease I- Patients with uterine myomas or adenomyosis
9. Patients with uterine anomaly
10. 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)

Primary outcomes:
measure: uterocervical angle
timeFrame: 6 months
Secondary outcomes:
measure: uterine volume
timeFrame: 6 months
measure: endometrial cavity length
timeFrame: 6 months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
Study officials:
References: