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

Assiut University

Status: Not yet enrolling

Conditions: Intrauterine Device Placement and Displacement; Evaluation of IUD Position Six Weeks After Insertion

Treatments: Biological: 2D Transvaginal Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT07138248

TV3D-IUD-2025

Details and patient eligibility

About

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.

Full 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

Enrollment: 138 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Females aged 18-45 years

Postpartum women receiving copper T380A IUD insertion, either vaginal or cesarean

Agree to participate and provide written informed consent

Exclusion criteria

• Uterine anomalies (e.g., bicornuate uterus)

Significant uterine pathology (e.g., large fibroids)

Puerperal sepsis

Refusal to insert IUD

Past history of IUD complications

Trial design

138 participants in 1 patient group

Postpartum Women Receiving IUD

Description:

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.

Treatment:

Biological: 2D Transvaginal Ultrasound