Transvaginal Three-Dimensional Ultrasound for Evaluation of Intrauterine Device Position Six Weeks After Insertion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 2D Transvaginal Ultrasound.
- Who it may be relevant to
- Registry conditions: Evaluation of IUD Position Six Weeks After Insertion, Intrauterine Device Placement and Displacement. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transvaginal Three-Dimensional Ultrasound in the Evaluation of Intrauterine Device Placement Six Weeks After Insertion: A Cross-Sectional Study
Overview
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
Interventions
- 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
Primary outcome measures
- Prevalence of IUD displacement 6 weeks after insertion [Time frame: 6 weeks after IUD insertion]
Secondary outcome measures (2)
- Accuracy of 3D vs 2D transvaginal ultrasound in detecting IUD displacement [Time frame: 6 weeks after IUD insertion]
- Accuracy of 3D vs 2D transvaginal ultrasound in detecting IUD displacement [Time frame: 6 weeks after IUD insertion]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
Egypt · 1 center
- Women's Health Hospital, Assiut — Asyut
Publications
- Abuhamad AZ, Singleton S, Zhao Y, Bocca S. The Z technique: an easy approach to the display of the mid-coronal plane of the uterus in volume sonography. J Ultrasound Med. 2006 May;25(5):607-12. doi: 10.7863/jum.2006.25.5.607. PMID 16632784
- Benacerraf BR, Shipp TD, Bromley B. Three-dimensional ultrasound detection of abnormally located intrauterine contraceptive devices which are a source of pelvic pain and abnormal bleeding. Ultrasound Obstet Gynecol. 2009 Jul;34(1):110-5. doi: 10.1002/uog.6421. PMID 19565532
- Nosseir MA, et al. Role of 3D-Ultrasound in Patients with Abnormal Uterine Bleeding for Detection of IUCD Malposition. Benha Med J. 2024;41(4):1-9.
- Thonneau P, Goulard H, Goyaux N. Risk factors for intrauterine device failure: a review. Contraception. 2001 Jul;64(1):33-7. doi: 10.1016/s0010-7824(01)00215-3. PMID 11535211
- Benacerraf BR, Shipp TD, Lyons JG, Bromley B. Width of the normal uterine cavity in premenopausal women and effect of parity. Obstet Gynecol. 2010 Aug;116(2 Pt 1):305-310. doi: 10.1097/AOG.0b013e3181e6cc10. PMID 20664389
- Wildemeersch D, Pett A, Jandi S, Hasskamp T, Rowe P, Vrijens M. Precision intrauterine contraception may significantly increase continuation of use: a review of long-term clinical experience with frameless copper-releasing intrauterine contraception devices. Int J Womens Health. 2013 Apr 30;5:215-25. doi: 10.2147/IJWH.S42784. Print 2013. PMID 23658502
- Teal SB, Sheeder J. IUD use in adolescent mothers: retention, failure and reasons for discontinuation. Contraception. 2012 Mar;85(3):270-4. doi: 10.1016/j.contraception.2011.07.001. PMID 22067773
- Lopez LM, Bernholc A, Zeng Y, Allen RH, Bartz D, O'Brien PA, Hubacher D. Interventions for pain with intrauterine device insertion. Cochrane Database Syst Rev. 2015 Jul 29;2015(7):CD007373. doi: 10.1002/14651858.CD007373.pub3. PMID 26222246
Identifiers
NCT: NCT07138248 · TV3D-IUD-2025