TVS, SHG, and MRI in Uterine Niche

NCT07279181 | Completed

• 1 other identifier: GKLW-2024-044-A
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Detection rates of niches

  Detection rates of niches

  Periprocedural

Secondary Outcomes (2)

• Residual myometrial thickness

  Periprocedural

• The differences in the detection of abnormal structures

  Periprocedural

Study Arms (1)

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Peace Maternity and Child Health Hospital: lead

Study Sites (1)

International Peace Maternity & Child Health Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (3)

• 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.

  PMID: 40481886 BACKGROUND

• Donnez 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.

  PMID: 32228874 BACKGROUND

• Klein 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.

  PMID: 37506497 BACKGROUND

Study Officials

• Jian Zhang

  The International Peace Maternity & Child Health Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 12, 2025
• Study Start: June 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: January 21, 2026

Record last verified: 2025-11

Locations

CN (1)