Clinical Value of Saline Infusion Sonohysterography in the Assessment of Cesarean Scar Defects

NCT07610668 | Recruiting

• 1 other identifier: K202604-36
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study selected patients who underwent cesarean section and were scheduled to undergo Saline Infusion Sonohysterography (SIS) for evaluating the structure of the incision. Clinical characteristics and clinical symptoms were collected. Combined with hysteroscopy, MRI, conventional ultrasound and SIS examination results, the study analyzed the detection rate of cesarean section diverticula by SIS, the changes in diverticulum size and the diagnostic efficacy of residual muscle layer thickness at the incision site. The surgical methods and clinical symptom improvement of patients with CSD after surgery were followed up for half a year to one year. The study aimed to clarify the guiding value of SIS in clinical decision-making and patient prognosis for patients, and to analyze the etiological relationship between the true incidence of CSD and clinical complications. Thus, it provided evidence-based basis for clinical events of cesarean section surgery → CSD → CSD complications → surgical treatment of CSD → patient prognosis, promoting the progress of precise diagnosis and treatment of female reproductive health.

Conditions

Infertility

Keywords

Saline Infusion Sonohysterography; Transvaginal ultrasonography; Cesarean scar diverticulum; Residual myometrial thickness

Outcome Measures

Primary Outcomes (3)

• The detection rate of cesarean scar diverticulum

  The detection rate of cesarean scar diverticulum refers to the proportion of patients in whom the diverticulum is identified through various diagnostic modalities among all patients examined.

  Day 1

• Clinical Pregnancy Rate

  The clinical pregnancy rate is defined as the proportion of patients with the presence of at least one intrauterine gestational sac with a visible fetal heartbeat, confirmed by transvaginal ultrasound.

  Up to 90 days of gestation

• Residual myometrial thickness

  The Residual myometrial thickness refers to the thickness of the myometrial layer at the uterine lower segment at the site of prior cesarean delivery.

  Day 1

Study Arms (1)

This group of patients received appropriate treatment based on the presence or absence of diverticul

The treatment plan was determined by the attending physician according to clinical guidelines and was strictly independent of this observational study protocol.

Procedure: diverticulum reconstruction surgery

Interventions

diverticulum reconstruction surgery PROCEDURE

This group of patients received conventional infertility treatment only, without undergoing diverticulum reconstruction surgery, in accordance with standard clinical practice.

This group of patients received appropriate treatment based on the presence or absence of diverticul

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The research population comprised adult women with a prior cesarean delivery who presented to Tangdu Hospital with symptoms including abnormal uterine bleeding, dysmenorrhea, prolonged menstrual spotting, or secondary infertility.

You may qualify if:

• More than 6 months after cesarean delivery;
• Presenting with clinical symptoms-including abnormal uterine bleeding, dysmenorrhea, prolonged menstrual spotting, or secondary infertility;
• Requiring saline infusion sonohysterography (SIS) to evaluate the cesarean scar.

You may not qualify if:

• Multiple cesarean deliveries;
• Patients contraindicated for saline infusion sonohysterography (SIS), including pregnancy or suspected pregnancy, failure to meet vaginal hygiene criteria, inability to cooperate during the procedure, or suboptimal image quality;
• Cases with incomplete clinical data or lost to follow-up.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tang-Du Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Li Zhang, MD

  The Second Affiliated Hospital of Air Force Military Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhang, MD

CONTACT

86-29-84778860; lilyzhang319_20@hotmail.com

Jing Ma, MM

CONTACT

+86-15529398263; 178937707@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 28, 2026
• Study Start: January 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be available beginning 6 months and ending 36 months following article publication.
• Access Criteria: To gain access, data requestors will need to contact the corresponding author and sign a formal data access agreement.

Locations

CN (1)