Can Uterocervical Angle Predict the Displacement of Copper Intrauterine Devices (T-Cu 380A)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- uterocervical angle
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 21-45
排除标准
- •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)
结局指标
主要结局
uterocervical angle
时间窗: 6 months
Uterocervical angle (UCA) is the angle measured in the triangle region between the anterior uterine segment and the cervical canal
次要结局
- endometrial cavity length(6 months)
- uterine volume(6 months)
研究者
Ozan Karadeniz
Principal investigator
Kanuni Sultan Suleyman Training and Research Hospital