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NCT Number: NCT07138248

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Women's Health Hospital, Assiut

Asyut, 17155, Egypt

Location contact

Women's Health Hospital, Assiut Women's Health Hospital, Assiut

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2D Transvaginal Ultrasound

Biological

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

Primary outcomes

  1. Prevalence of IUD displacement 6 weeks after insertion

    Time frame: 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

Secondary outcomes

  1. Accuracy of 3D vs 2D transvaginal ultrasound in detecting IUD displacement

    Time frame: 6 weeks after IUD insertion

    Comparison of the diagnostic performance (sensitivity, specificity) of 3D versus 2D ultrasound in identifying malpositioned IUDs, including partial expulsion, embedment, or perforation

  2. Accuracy of 3D vs 2D transvaginal ultrasound in detecting IUD displacement

    Time frame: 6 weeks after IUD insertion

    Comparison of the diagnostic performance (sensitivity, specificity) of 3D versus 2D ultrasound in identifying malpositioned IUDs, including partial expulsion, embedment, or perforation.

Study contacts

Contact information is provided by the study sponsor or research team.

Amira Khaled Khafaga, resident

CONTACT

[email protected]

01019895625

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.