Ignite Creation Date:
2024-05-06 @ 7:22 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05996926
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-18
First Post:
2023-08-03
Brief Title:
Diagnostic Accuracy of Saline Sonohystrography vs 3D Transvaginal Ultrasound for Cesarean Scar Defect Assessment
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None