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

ConditionInfertility
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-50
SponsorTang-Du Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • diverticulum reconstruction surgery

    Procedure/Surgery

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

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: This group of patients received appropriate treatment based on the presence or absence of diverticul1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1
2

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.

Time frame
Up to 90 days of gestation
3

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.

Time frame
Day 1

Secondary outcomes

Other outcomes

Sponsors and contacts

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