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Completed

NCT Number: NCT07279181

TVS, SHG, 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.

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Key information

Conditions

Uterine Niche

Sex eligibility

Female

Study type

Observational

Primary location

International Peace Maternity & Child Health Hospital

Shanghai, Shanghai Municipality, 200030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Detection rates of niches

    Time frame: Periprocedural

    Detection rates of niches

Secondary outcomes

  1. Residual myometrial thickness

    Time frame: Periprocedural

    Residual myometrial thickness of niches measured by TVS, SHG and MRI

  2. The differences in the detection of abnormal structures

    Time frame: Periprocedural

    The differences in the detection of abnormal structures

Sponsors and collaborators

Lead sponsor

International Peace Maternity and Child Health Hospital

Other

Registry information

Official study title

Comparative Assessment of Transvaginal Ultrasound, Hysterosonography, and MRI in Uterine Niche

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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