TVS, SHG, and MRI in Uterine Niche

January 18, 2026 updated by: International Peace Maternity and Child Health Hospital

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • International Peace Maternity & Child Health Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The sample size is the actual number included within the study time frame

Description

Inclusion Criteria:

  • Women (18-45 years) diagnosed with CSD at our center.
  • Women having postmenstrual spotting after CS
  • Signed informed consent.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rates of niches
Time Frame: Periprocedural
Detection rates of niches
Periprocedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual myometrial thickness
Time Frame: Periprocedural
Residual myometrial thickness of niches measured by TVS, SHG and MRI
Periprocedural
The differences in the detection of abnormal structures
Time Frame: Periprocedural
The differences in the detection of abnormal structures
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Peace Maternity and Child Health Hospital

Investigators

  • Study Chair: Jian Zhang, The International Peace Maternity & Child Health Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 30, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GKLW-2024-044-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Ask the principal investigator by email

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uterine Niche

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe