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

Intrauterine Device Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05556421
• Other study ID #: KanuniSSEAH2
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: September 2022
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: July 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Intrauterine Device

Intervention

Diagnostic Test:
• uterocervical angle
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.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	uterine volume	Uterine volume was accepted as ellipsoid with transvaginal ultrasonography device measured in transverse, longitudinal, and antero-posterior planes and volume was calculated in cm3.	6 months
Secondary	endometrial cavity length	The length of the endometrial cavity (ECL) was determined as the canal extending from the beginning of the internal cervical os to the uterine fundus endometrium.	6 months