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

NCT07138248 | Not Yet Recruiting

• 1 other identifier: TV3D-IUD-2025
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Intrauterine Device; 3D Transvaginal Ultrasound; Postpartum Contraception

Outcome Measures

Primary Outcomes (1)

• Prevalence of IUD displacement 6 weeks after 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

  6 weeks after IUD insertion

Secondary Outcomes (2)

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

  6 weeks after IUD insertion

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

  6 weeks after IUD insertion

Study Arms (1)

Postpartum Women Receiving IUD

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.

Biological: 2D Transvaginal Ultrasound

Interventions

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

Postpartum Women Receiving IUD

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Postpartum women aged 18-45 undergoing copper T380A IUD insertion at Assiut General Hospital or Women's Health Hospital, Assiut, Egypt, who consent to follow-up ultrasound assessment six weeks after insertion.

You may qualify if:

• Females aged 18-45 years
• Postpartum women receiving copper T380A IUD insertion, either vaginal or cesarean
• Agree to participate and provide written informed consent

You may not qualify if:

• Uterine anomalies (e.g., bicornuate uterus)
• Significant uterine pathology (e.g., large fibroids)
• Puerperal sepsis
• Refusal to insert IUD
• Past history of IUD complications

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women's Health Hospital, Assiut

Asyut, 17155, Egypt

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Goldstuck ND, Wildemeersch D. Role of uterine forces in intrauterine device embedment, perforation, and expulsion. Int J Womens Health. 2014 Aug 7;6:735-44. doi: 10.2147/IJWH.S63167. eCollection 2014.

  PMID: 25143756 BACKGROUND

• Committee on Practice Bulletins-Gynecology, Long-Acting Reversible Contraception Work Group. Practice Bulletin No. 186: Long-Acting Reversible Contraception: Implants and Intrauterine Devices. Obstet Gynecol. 2017 Nov;130(5):e251-e269. doi: 10.1097/AOG.0000000000002400.

  PMID: 29064972 BACKGROUND

Central Study Contacts

Amira Khaled Khafaga, resident

CONTACT

01019895625; amirakhaled456457458@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Obstetric and Gynecology Department

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: August 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)