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Starting soon Observational

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

NCT07138248 · tracked via the Priya Life Science Egypt tracker
Phase
Observational
Started
2025-09
Last updated
2025-08-22

Condition(s) studied

Evaluation of IUD Position Six Weeks After InsertionIntrauterine Device Placement and Displacement

Investigational drug(s) / intervention(s)

2D Transvaginal Ultrasound

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

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Prevalence of IUD displacement 6 weeks after insertion — 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

Trial sites (1)

FacilityCityRegionStatus
Women's Health Hospital, Assiut Asyut Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07138248 on ClinicalTrials.gov ↗ ← All trials in Egypt