Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06324331
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-03-15
Brief Title:
Effect of Decidual Sparing in cs Niche Formation
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
The Impact of Decidual al Sparing During Uterine Closure on Post Cesarean Niche Formation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
Assessing the impact of endometrial sparing at double-layer uterine closure as a specific surgical technique in CS to reduce the rate of post-cessarian delivery niche develoment
Detailed Description:
A Cesarean scar defect CSD or niche also termed isthmocele has been the subject of intensive research over the past 20 years which resulted in over 3000 publications worldwide At the beginning of the twentieth century a cesarean scar described as furrow was noted in hysterectomized uteri of women after a Cesarean delivery CD In 2001 Monteagudo et al described a specific intrauterine defect or niche using saline infusion sonohysterography SIS as a triangular hypoechoic anechoic fluid-filled space present in uteri of 40 women with postmenopausal bleeding who had a previous cesarean delivery reflecting a discontinuity of the myometrium at the site of the uterine incision scar most likely the result of incomplete healingThe degree of defect referring to the size of the niche and the thinness of the residual myometrial thickness RMT by ultrasound is often associated with a higher complication rate The presence of a niche is associated with other dangerous obstetrical complications such as Cesarean scar pregnancies CSP placenta accreta spectrum PAS as well as numerous gynecological problems including intermenstrual spotting dysmenorrhea pelvic pain subfertility and suboptimal IVF implantation rate3As the absolute number of CDs increased their associated complications presented significant challenges for patients providers and researchers Several hypotheses have been advanced to explain niche formation including oxygen deprivation poor tissue healing surgical techniques and maternal factorsA recent publication described the origin of a post-CD niche following uterine closure The authors outlined the uterine defect immediately by SIS and using histopathological studies demonstrated the presence of the decidua lining the defect extending and penetrating the surface of the incision The inclusion of the endometrium into the uterine closure and lack of myometrial approximation were video recordedAlthough these findings have implications for layer-to-layer approximation the clinical relevance of niche development remains unclear as its association with intrinsic surgical techniques remains poorly investigated Possible reasons Most studies include heterogeneous groups of patients surgeons and uterine closure techniques offering no uniform understanding of niche development and size Reading the history of uterine closure techniques in 1882 Max Sänger cautioned to avoid the decidua into the uterine closure of the classical cesarean operation which has become the present-day classical CS8 The practice of avoiding including the decidua into the uterine wall closure was taught and practiced until the 1970s gradually losing popularity as newer closure techniques were described10-12 These more recent developments made no reference to how to handle the endometrium during incision closure The impact of the endometrium on scar strength and integrity has been studied in animal and human modelsA recent retrospective study of 4496 consecutive deliveries was conducted and concluded that there was no abnormal placentation in subsequent pregnancies of 737 women who underwent a CD during the 30-year period when a specific technique termed endometrium-free uterine closure technique EFCT was employed16 This study compares the incidence and size of uterine niches after routine closure technique of the CD incision versus the EFCT using TVUS in their non-pregnant state among women with one prior CD
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