Women's Health Hospital, Assiut
Asyut, 17155, Egypt
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Women's Health Hospital, Assiut Women's Health Hospital, Assiut
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NCT Number: NCT07138248
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.
Trial opening soon.
Get Notified18 year–45 year
Female
Observational
Asyut, 17155, Egypt
Women's Health Hospital, Assiut Women's Health Hospital, Assiut
CONTACT
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Postpartum women receiving copper T380A IUD insertion, either vaginal or cesarean
Agree to participate and provide written informed consent
Exclusion criteria
Significant uterine pathology (e.g., large fibroids)
Puerperal sepsis
Refusal to insert IUD
Past history of IUD complications
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
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
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
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.
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Transvaginal Three-Dimensional Ultrasound in the Evaluation of Intrauterine Device Placement Six Weeks After Insertion: A Cross-Sectional Study
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