Transvaginal Three-Dimensional Ultrasound in the Evaluation of Intrauterine Device Placement Six Weeks After Insertion: A Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Prevalence of IUD displacement 6 weeks after insertion
研究概览
简要总结
This study aims to evaluate the position of intrauterine devices (IUDs) six weeks after insertion using transvaginal three-dimensional (3D) ultrasound. Women aged 18-45 who undergo postpartum IUD insertion, either vaginally or during cesarean delivery, will be included. The study will compare the accuracy of 3D ultrasound versus conventional two-dimensional (2D) ultrasound in detecting IUD displacement, including partial expulsion, embedment, or perforation.
Participants will receive a copper T380A IUD, and all procedures will follow standard clinical protocols. Ultrasound assessments will be conducted six weeks after insertion to confirm proper placement. Data collected will include demographic information, reproductive history, and ultrasound findings.
The primary outcome is the prevalence of IUD displacement at six weeks. Secondary outcomes include the diagnostic accuracy of 3D versus 2D ultrasound. This study is designed to improve early detection of malpositioned IUDs, enhancing patient safety and contraceptive effectiveness.
详细描述
Intrauterine devices (IUDs) are highly effective, long-acting reversible contraceptives. Complications such as expulsion, perforation, and embedment can reduce contraceptive effectiveness and cause abnormal uterine bleeding or pelvic pain. Traditional 2D transvaginal ultrasound may fail to detect malpositioned IUDs, especially levonorgestrel-IUDs or when uterine anomalies are present. 3D transvaginal ultrasound offers improved visualization of the uterine cavity and IUD position.
Objectives
To evaluate the accuracy of 3D transvaginal ultrasound in detecting IUD displacement six weeks after insertion and compare it to conventional 2D ultrasound.
Methods
Study Design: Cross-sectional study Setting: Assiut General Hospital and Women's Health Hospital, Assiut, Egypt Duration: July 2025 - June 2026 Participants: Women aged 18-45 receiving postpartum IUD insertion (vaginal or cesarean) Sample Size: 138 women, accounting for 10% loss to follow-up
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 18-45 years
- •Postpartum women receiving copper T380A IUD insertion, either vaginal or cesarean
- •Agree to participate and provide written informed consent
排除标准
- •Uterine anomalies (e.g., bicornuate uterus)
- •Significant uterine pathology (e.g., large fibroids)
- •Puerperal sepsis
- •Refusal to insert IUD
- •Past history of IUD complications
研究组 & 干预措施
Postpartum Women Receiving IUD
Women aged 18-45 who undergo postpartum copper T380A IUD insertion, either vaginally or during cesarean delivery, and who consent to follow-up ultrasound at 6 weeks to assess IUD position.
干预措施: 2D Transvaginal Ultrasound (Biological)
结局指标
主要结局
Prevalence of IUD displacement 6 weeks after insertion
时间窗: 6 weeks after IUD insertion
The proportion of postpartum women whose copper T380A IUD is malpositioned, partially expelled, embedded, or perforated as determined by transvaginal ultrasound at 6 weeks post-insertion
次要结局
- Accuracy of 3D vs 2D transvaginal ultrasound in detecting IUD displacement(6 weeks after IUD insertion)
研究者
Amira khaled mohamed khafaga
Resident, Obstetric and Gynecology Department
Assiut University