NCT07138248

Transvaginal Three-Dimensional Ultrasound for Evaluation of Intrauterine Device Position Six Weeks After Insertion

Transvaginal Three-Dimensional Ultrasound in the Evaluation of Intrauterine Device Placement Six Weeks After Insertion: A Cross-Sectional Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 138 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 Procedures: Participants provide written informed consent. Baseline data collection: age, parity, residency, educational level, reproductive history, prior IUD use, dysmenorrhea, cervical surgery, lactation status. Copper T380A IUD insertion: Vaginal insertion: sterile technique, uterine sounding, insertion per manufacturer instructions. Cesarean insertion: IUD placed in uterine fundus post-placenta delivery before uterine closure. Follow-up at 6 weeks with 2D and 3D transvaginal ultrasound to assess IUD position. Outcomes: Primary: Prevalence of IUD displacement at 6 weeks Secondary: Accuracy of 3D vs 2D ultrasound in detecting displacement, partial expulsion, embedment, and perforation. Data Management: Data entered and analyzed using SPSS v21. Categorical variables: Chi-square or Fisher's exact test Quantitative variables: Shapiro-Wilkes test for normality; Mann-Whitney or Student's t-test as appropriate Significance: p \< 0.05 Ethical Considerations Study approved by Assiut Faculty of Medicine Ethical Review Committee Conducted according to Declaration of Helsinki and Good Clinical Practice Participant privacy and confidentiality ensured

Conditions

• Evaluation of IUD Position Six Weeks After Insertion
• Intrauterine Device Placement and Displacement

Interventions

Type	Name	Description
BIOLOGICAL	2D Transvaginal Ultrasound	Three-dimensional transvaginal ultrasound used to assess the same outcomes as 2D, providing volumetric imaging and coronal reconstruction to detect displacement or malposition of the IUD

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2025-08-22
• Last updated: 2025-08-22

Locations

1 site across 1 country: Egypt