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

Sponsor
Kanuni Sultan Suleyman Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05556421
Collaborator
(none)
123
1
5.9
20.7

Study Details

Study Description

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

  1. 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.
Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: uterocervical angle

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.

Study Design

Study Type:
Observational
Actual Enrollment :
123 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Can Uterocervical Angle Predict the Displacement of Copper Intrauterine Devices (T-Cu 380A)
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jun 1, 2021
Actual Study Completion Date :
Jul 1, 2021

Arms and Interventions

Arm Intervention/Treatment
case group

dislocated intrauterine device

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.

control group

normal intrauterine device position

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.

Outcome Measures

Primary Outcome Measures

  1. uterocervical angle [6 months]

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

Secondary Outcome Measures

  1. uterine volume [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kanuni Sultan Suleyman Training and Research Hospital İstanbul Turkey 34307

Sponsors and Collaborators

  • Kanuni Sultan Suleyman Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ozan Karadeniz, Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05556421
Other Study ID Numbers:
  • KanuniSSEAH2
First Posted:
Sep 27, 2022
Last Update Posted:
Sep 27, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ozan Karadeniz, Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital

Study Results

No Results Posted as of Sep 27, 2022