Clinical trial NCT05996926: Diagnostic Accuracy of Saline Sonohystrography vs. 3D Transvaginal Ultrasound for Cesarean Scar Defect Assessment
Official title: Diagnostic Correlation Between Saline Infused Sonohystrography and Three Dimensional Transvaginal Ultrasound in the Assessment of Cesarean Section Scar Defect. A Study of a Diagnostic Test Accuracy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cesarean Scar Defects
Cesarean Section Complications
Uterine Scar Dehiscence
Vaginal Birth After Cesarean
Abnormal Uterine Bleeding
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 72
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To compare accuracy of three dimensional transvaginal ultrasound versus the "gold standard" saline infused sonography for assessing the characteristics, frequency and appearance of caesarean scar defects in symptomatic patients with a history of cesarean section.

Detailed description: Cesarean section (CS) is a frequently performed surgical procedure in obstetric practice. With a significant number of women undergoing this procedure annually, studying its impact on future reproductive capacity has become increasingly important.

The prevalence of cesarean deliveries is rising and constitutes about one-third of all births in both the USA and Italy. As the use of cesarean delivery increases, so do the associated complications, including cesarean scar pregnancy, morbidly adherent placenta, and Cesarean section scar dehiscence and rupture.

Cesarean scar defects (CSD) are described using various terms (pouch, niche, or isthmocoele) and are characterized by thinning of the myometrium or a uterine scar dehiscence, often appearing as a triangular shape within the endometrial cavity.

The exact prevalence of symptomatic Cesarean scar defects varies due to factors like population differences and lack of standardized criteria. Clinical presentations of Cesarean scar defects range from no symptoms to abnormal uterine bleeding, infertility, dyspareunia, and pelvic pain.

Women with a history of Cesarean section are considered high-risk during pregnancy and require specialized assessments to ensure scar integrity. Saline-infused sonography (Sonohystrography) is effective for demonstrating caesarean niches, although transvaginal ultrasound (TVS) is more accessible and commonly used.

Experts generally agree that a niche should be defined by an indentation at the CS scar site with a depth of at least 2 mm, and it can be classified as simple, simple with one branch, or complex with multiple branches. Additional measurements, such as the distances between the niche and the vesicovaginal fold, are useful for surgical planning.

Given the increasing frequency of cesarean deliveries, healthcare providers will encounter related complications more frequently. Cesarean scar defects are common yet often go undiagnosed. Encouraging vaginal birth after cesarean (VBAC) can help reduce cesarean rates and raise questions about future obstetric practices, especially in developing countries.

Eligibility criteria: Inclusion Criteria:

* Age between 20 and 45 years
* Previous 1-3 cesarean sections
* The duration from the last cesarean section ranging from 6 months to 5 years.

Exclusion Criteria:

* Pregnancy (Positive pregnancy test)
* Recent pelvic infection.
* Active pelvic infection.
* Recent surgery on the tubes or the uterus.
* Active vaginal bleeding.
* Menstruation.
* Suspected malignancy.
* Intrauterine device in situ.

Primary outcomes:
measure: Diagnostic Accuracy of Cesarean Scar Defect Assessment Using 3D TVS
timeFrame: Intraoperatively
measure: Diagnostic Accuracy of Cesarean Scar Defect Assessment Using Saline-Infused Sonography
timeFrame: Intraoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: