Evaluation of IUD Position Six Weeks After InsertionNCT07138248
Transvaginal Three-Dimensional Ultrasound for Evaluation of Intrauterine Device Position Six Weeks After Insertion
An observational study of Evaluation of IUD Position Six Weeks After Insertion and Intrauterine Device Placement and Displacement, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Evaluation of IUD Position Six Weeks After Insertion, Intrauterine Device Placement and Displacement
- What is being tested?
- 2D Transvaginal Ultrasound
- How many people
- 138 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Females aged 18-45 years
- Postpartum women receiving copper T380A IUD insertion, either vaginal or cesarean
- Agree to participate and provide written informed consent
Who cannot join
- Uterine anomalies (e.g., bicornuate uterus)
- Significant uterine pathology (e.g., large fibroids)
- Puerperal sepsis
- Refusal to insert IUD
- Past history of IUD complications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Women's Health Hospital, Assiut
Asyut, 17155
Women's Health Hospital, Assiut Women's Health Hospital, Assiut
About this study
Official title: Transvaginal Three-Dimensional Ultrasound in the Evaluation of Intrauterine Device Placement Six Weeks After Insertion: A Cross-Sectional Study
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.
Read the 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
- Conditions
- Evaluation of IUD Position Six Weeks After Insertion, Intrauterine Device Placement and Displacement
- Being tested
- 2D Transvaginal Ultrasound
- Keywords
- Intrauterine Device, 3D Transvaginal Ultrasound, Postpartum Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D Transvaginal UltrasoundBiological
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: 2D Transvaginal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks after IUD insertion
Secondary outcomes (2)
Accuracy of 3D vs 2D transvaginal ultrasound in detecting IUD displacement
Comparison of the diagnostic performance (sensitivity, specificity) of 3D versus 2D ultrasound in identifying malpositioned IUDs, including partial expulsion, embedment, or perforation
Measured: 6 weeks after IUD insertion
Accuracy of 3D vs 2D transvaginal ultrasound in detecting IUD displacement
Comparison of the diagnostic performance (sensitivity, specificity) of 3D versus 2D ultrasound in identifying malpositioned IUDs, including partial expulsion, embedment, or perforation.
Measured: 6 weeks after IUD insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Evaluation of IUD Position Six Weeks After InsertionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira khaled mohamed khafaga, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138248
- Sponsor's protocol ID
- TV3D-IUD-2025
- Status last verified
- Jul 2025
- First submitted
- 16 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16632784Benacerraf 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.
PubMed 19565532Nosseir 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.
PubMed 11535211Benacerraf 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.
PubMed 20664389Wildemeersch 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.
PubMed 23658502Teal 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.
PubMed 22067773Lopez 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.
PubMed 26222246Goldstuck 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.
PubMed 25143756Committee 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.
PubMed 29064972
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Three-Dimensional Ultrasound in the Evaluation of Intrauterine Device Placement Six Weeks After Insertion: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07138248
- Acronym / sponsor ID
- TV3D-IUD-2025
- Conditions
- Evaluation of IUD Position Six Weeks After Insertion, Intrauterine Device Placement and Displacement
- Keywords
- Intrauterine Device, 3D Transvaginal Ultrasound, Postpartum Contraception
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postpartum Women Receiving IUD | – | Biological: 2D Transvaginal UltrasoundWomen 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Females aged 18-45 years
- Postpartum women receiving copper T380A IUD insertion, either vaginal or cesarean
- Agree to participate and provide written informed consent
Key exclusion criteria (5 listed)
- Uterine anomalies (e.g., bicornuate uterus)
- Significant uterine pathology (e.g., large fibroids)
- Puerperal sepsis
- Refusal to insert IUD
- Past history of IUD complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2D Transvaginal UltrasoundThree-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 | Biological | Postpartum Women Receiving IUD |
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Results publication: PubMed 16632784Abuhamad 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.
- Results publication: PubMed 19565532Benacerraf 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.
- Results publicationNosseir 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.
- Results publication: PubMed 11535211Thonneau 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.
- Results publication: PubMed 20664389Benacerraf 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.
- Results publication: PubMed 23658502Wildemeersch 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.
- Results publication: PubMed 22067773Teal 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.
- Results publication: PubMed 26222246Lopez 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.
- Results publication: PubMed 25143756Goldstuck 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.
- Results publication: PubMed 29064972Committee 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluation of IUD Position Six Weeks After Insertion and Intrauterine Device Placement and Displacement, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira Khaled Khafaga, resident (01019895625, amirakhaled456457458@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of IUD displacement 6 weeks after insertion (time frame: 6 weeks after IUD insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07138248, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.