Uterine NicheNCT07279181
TVS, SHG, and MRI in Uterine Niche
An observational study of Uterine Niche, run by International Peace Maternity and Child Health Hospital at 1 site in China.
Trial summary
Uterine niche is a defect formed by poor healing of the lower uterine myometrium after cesarean section, defined as a depression of at least 2mm in the uterine myometrium at the cesarean scar; it is associated with gynecological symptoms and even life-threatening pregnancy complications, so accurate imaging evaluation… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Uterine Niche
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The sample size is the actual number included within the study time frame
Who may be able to join
- Women (18-45 years) diagnosed with CSD at our center.
- Women having postmenstrual spotting after CS
- Signed informed consent.
Who cannot join
- Women who has a positive urine pregnancy test.
- Presence of an intrauterine device.
- With poor image quality from image will be excluded.
- Refuse to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
International Peace Maternity & Child Health Hospital
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Comparative Assessment of Transvaginal Ultrasound, Hysterosonography, and MRI in Uterine Niche
Uterine niche is a defect formed by poor healing of the lower uterine myometrium after cesarean section, defined as a depression of at least 2mm in the uterine myometrium at the cesarean scar; it is associated with gynecological symptoms and even life-threatening pregnancy complications, so accurate imaging evaluation is crucial for diagnosis, symptom grading, and treatment planning. Currently, transvaginal ultrasound (TVS), saline hysterosonography (SHG), and magnetic resonance imaging (MRI) are commonly used for evaluation, but there are controversies about the consistency of their measurements and repeatability of results. This observational study, conducted at the International Peace Maternity and Child Health Hospital affiliated with Shanghai Jiao Tong University School of Medicine, included women diagnosed with uterine niche.
- Conditions
- Uterine Niche
- Keywords
- Uterine niche, MRI, Ultrasound, Hysterosonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women diagnosed with uterine niche | Women diagnosed with uterine niche, all patients underwent ultrasound, hysterosonography, and thin-slice MRI before surgery, and hysteroscopic evaluation of the niche was completed during the operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rates of niches
Detection rates of niches
Measured: Periprocedural
Secondary outcomes (2)
Residual myometrial thickness
Residual myometrial thickness of niches measured by TVS, SHG and MRI
Measured: Periprocedural
The differences in the detection of abnormal structures
The differences in the detection of abnormal structures
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Jun 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uterine NicheStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Peace Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Zhang, Study chair, The International Peace Maternity & Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279181
- Sponsor's protocol ID
- GKLW-2024-044-A
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Ask the principal investigator by email
Publications
Araujo Santana Tavares M, Busoletto Tripode BG, Kozlowski Andreucci B, Bezerra Cirne E, Almeida Sathler Bretas E, Rios Torres L, Oliveira Pacheco E, S Torres U, D'Ippolito G. Isthmic uterine lesions: a comprehensive pictorial review of MRI features and management strategies. Abdom Radiol (NY). 2025 Dec;50(12):6076-6084. doi: 10.1007/s00261-025-05037-0. Epub 2025 Jun 7.
PubMed 40481886Donnez O. Cesarean scar defects: management of an iatrogenic pathology whose prevalence has dramatically increased. Fertil Steril. 2020 Apr;113(4):704-716. doi: 10.1016/j.fertnstert.2020.01.037.
PubMed 32228874Klein Meuleman SJM, Min N, Hehenkamp WJK, Post Uiterweer ED, Huirne JAF, de Leeuw RA. The definition, diagnosis, and symptoms of the uterine niche - A systematic review. Best Pract Res Clin Obstet Gynaecol. 2023 Aug;90:102390. doi: 10.1016/j.bpobgyn.2023.102390. Epub 2023 Jul 15.
PubMed 37506497
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of Transvaginal Ultrasound, Hysterosonography, and MRI in Uterine Niche
- ClinicalTrials.gov ID
- NCT07279181
- Acronym / sponsor ID
- GKLW-2024-044-A
- Conditions
- Uterine Niche
- Keywords
- Uterine niche, MRI, Ultrasound, Hysterosonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- International Peace Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 12 Dec 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.
Uterine niche is a defect formed by poor healing of the lower uterine myometrium after cesarean section, defined as a depression of at least 2mm in the uterine myometrium at the cesarean scar; it is associated with gynecological symptoms and even life-threatening pregnancy complications, so accurate imaging evaluation is crucial for diagnosis, symptom grading, and treatment planning. Currently, transvaginal ultrasound (TVS), saline hysterosonography (SHG), and magnetic resonance imaging (MRI) are commonly used for evaluation, but there are controversies about the consistency of their measurements and repeatability of results. This observational study, conducted at the International Peace Maternity and Child Health Hospital affiliated with Shanghai Jiao Tong University School of Medicine, included women diagnosed with uterine niche.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women diagnosed with uterine niche | – | –Women diagnosed with uterine niche, all patients underwent ultrasound, hysterosonography, and thin-slice MRI before surgery, and hysteroscopic evaluation of the niche was completed during the operation. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The sample size is the actual number included within the study time frame
Key inclusion criteria (3 listed)
- Women (18-45 years) diagnosed with CSD at our center.
- Women having postmenstrual spotting after CS
- Signed informed consent.
Key exclusion criteria (4 listed)
- Women who has a positive urine pregnancy test.
- Presence of an intrauterine device.
- With poor image quality from image will be excluded.
- Refuse to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection rates of niches
Time frame: Periprocedural
Detection rates of niches
2 secondary outcomes
Residual myometrial thickness
Time frame: Periprocedural
The differences in the detection of abnormal structures
Time frame: Periprocedural
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 40481886Araujo Santana Tavares M, Busoletto Tripode BG, Kozlowski Andreucci B, Bezerra Cirne E, Almeida Sathler Bretas E, Rios Torres L, Oliveira Pacheco E, S Torres U, D'Ippolito G. Isthmic uterine lesions: a comprehensive pictorial review of MRI features and management strategies. Abdom Radiol (NY). 2025 Dec;50(12):6076-6084. doi: 10.1007/s00261-025-05037-0. Epub 2025 Jun 7.
- Background: PubMed 32228874Donnez O. Cesarean scar defects: management of an iatrogenic pathology whose prevalence has dramatically increased. Fertil Steril. 2020 Apr;113(4):704-716. doi: 10.1016/j.fertnstert.2020.01.037.
- Background: PubMed 37506497Klein Meuleman SJM, Min N, Hehenkamp WJK, Post Uiterweer ED, Huirne JAF, de Leeuw RA. The definition, diagnosis, and symptoms of the uterine niche - A systematic review. Best Pract Res Clin Obstet Gynaecol. 2023 Aug;90:102390. doi: 10.1016/j.bpobgyn.2023.102390. Epub 2023 Jul 15.
- Individual participant dataSharing planned: Undecided. Ask the principal investigator by email
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Uterine Niche
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. This study is not recruiting at the moment.
Jian Zhang study chair
The International Peace Maternity & Child Health Hospital
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 Uterine Niche, run by International Peace Maternity and Child Health Hospital at 1 site in China.
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 4 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: finished, as of the sponsor's last update on 21 Jan 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rates of niches (time frame: Periprocedural). 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 NCT07279181, which also lists 3 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 21 Jan 2026.