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Completed

NCT Number: NCT05556421

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

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.

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Key information

Conditions

Age range

21 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34307, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged between 21-45

Exclusion criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. uterocervical angle

    Time frame: 6 months

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

Secondary outcomes

  1. uterine volume

    Time frame: 6 months

    Uterine volume was accepted as ellipsoid with transvaginal ultrasonography device measured in transverse, longitudinal, and antero-posterior planes and volume was calculated in cm3.

  2. endometrial cavity length

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 27, 2022
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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