- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07610668
Clinical Value of Saline Infusion Sonohysterography in the Assessment of Cesarean Scar Defects
Preliminary Clinical Application Study of Saline Infusion Onohysterography in Structure of Cesarean Scar Surgery
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Background and Rationale:
The precise assessment of the structure of the cesarean section incision is the core of achieving "individualized surgery". Through multi-dimensional analysis of anatomical structure, functional status, and patient needs, one can precisely select hysteroscopy, laparoscopy, or combined surgical methods, significantly improving symptom relief rate, diverticulum closure rate, and reducing the risks of recurrence and pregnancy complications. However, preoperative precise diagnosis is the prerequisite for treatment. The SIS technology can obtain a good acoustic window through a simple uterine cavity water injection method, clearly displaying the structure of the cesarean section incision, enhancing the diagnostic confidence of ultrasound doctors, providing more detailed diagnoses for patients and clinicians, and is expected to replace diagnostic hysteroscopy operations. In the future, it is necessary to promote the standardization of assessment and technology transformation, ultimately achieving the leap from "treatment based on symptoms" to "precise repair" of CSD, improving the long-term prognosis of patients.
Study Design and Methodology:
This is a single-center, prospective, observational cohort study. The objective is to To explore the diagnostic value of the acoustic contrast imaging technique using normal saline for the uterine cavity in the assessment of the incision structure after cesarean section.
This study included patients who were scheduled for cesarean section for secondary infertility from January 2023 to July 2025 as the research subjects. General clinical data of the patients were collected, including age, history of cesarean section, gynecological history, time of secondary infertility, whether there was excessive menstrual bleeding or dysmenorrhea, etc.
Data Collection and Assessments:
This study included patients who were scheduled for cesarean section for secondary infertility from January 2023 to July 2025 as the research subjects. General clinical data of the patients were collected, including age, history of cesarean section, gynecological history, time of secondary infertility, whether there was excessive menstrual bleeding or dysmenorrhea, etc.The primary ultrasonographic parameters to be recorded include:
During TVUS, assess whether a diverticulum is present at the cesarean section incision site. If identified, measure its longitudinal diameter, transverse diameter, depth, residual myometrial thickness, and the distance from the lower margin of the diverticulum to the external cervical os, in accordance with international consensus guidelines. During SIS, evaluate the presence of a diverticulum. In cases where a diverticulum is detected, apply the conventional TVUS measurement protocol to quantify all relevant dimensions and assess for associated complications-including cysts or polyps-as well as overall uterine cavity morphology. Concurrently, collect MRI and hysteroscopy findings.
Follow-up and Endpoints:
Following surgical intervention, participants will undergo longitudinal follow-up, including documentation of the surgical approach, clinical symptom status at 6 months postoperatively, and pregnancy outcomes at 12 months postoperatively. Analyze the aggregated data to determine the clinical decision-making utility of SIS.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Li Zhang, MD
- Telefonnummer: 86-29-84778860
- E-Mail: lilyzhang319_20@hotmail.com
Studieren Sie die Kontaktsicherung
- Name: Jing Ma, MM
- Telefonnummer: +86-15529398263
- E-Mail: 178937707@qq.com
Studienorte
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Shaanxi
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Xi'an, Shaanxi, China, 710038
- Rekrutierung
- Tang-Du Hospital
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Kontakt:
- Li Zhang, MD
- Telefonnummer: 86-29-84778860
- E-Mail: lilyzhang319_20@hotmail.com
-
Kontakt:
- Jing Ma, MM
- Telefonnummer: +86-15529398263
- E-Mail: 178937707@qq.com
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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.
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This group of patients received conventional infertility treatment only, without undergoing diverticulum reconstruction surgery, in accordance with standard clinical practice.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Klinische Schwangerschaftsrate
Zeitfenster: Bis zu 90 Tagen der Schwangerschaft
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Die klinische Schwangerschaftsrate ist definiert als der Anteil der Patientinnen mit mindestens einem intrauterinen Gestationssack mit sichtbarem fetalen Herzschlag, bestätigt durch transvaginalen Ultraschall.
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Bis zu 90 Tagen der Schwangerschaft
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The detection rate of cesarean scar diverticulum
Zeitfenster: Day 1
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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.
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Day 1
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Residual myometrial thickness
Zeitfenster: Day 1
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The Residual myometrial thickness refers to the thickness of the myometrial layer at the uterine lower segment at the site of prior cesarean delivery.
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Day 1
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Li Zhang, MD, The Second Affiliated Hospital of Air Force Military Medical University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- K202604-36
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
IPD-Sharing-Zeitrahmen
IPD-Sharing-Zugriffskriterien
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- ICF
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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