NCT04766073

Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 183 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: Female
• Age: 17 Years – 50 Years
• Healthy volunteers: Accepted

Summary

In the last decade we have been exposed to the complication of a caesarean section called a "niche". A niche is an anaerobic defect in the location of the cesarean section, which represents the discontinuity of the endometrium and myometrium. A niche is usually diagnosed by ultrasound, and can also be diagnosed by hysterosalpingogram or hysteroscopy. In the presence of a niche women suffer more frequently from irregular bleeding, dysmenorrhea, chronic pelvic pain, and dyspareunia. We believe that a combination of tissue ischemia and thinning of the scar tissue that forms, causes a niche to form. Large randomized studies regarding the preferred surgical technique in cesarean section, including various methods of incision closure have found that there is no single method that is obviously superior. However, these studies did not examine niche formation as a complication of cesarean section. In this study we will examine whether a unique incision closure method reduces post-cesarean niche formation.

Conditions

• Cesarean Section Complications
• Uterine Bleeding

Interventions

Type	Name	Description
PROCEDURE	Niche prevention suture	This group will have the uterus sutured in two layers using a new technique.

Timeline

• Start date: 2021-07-22
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2021-02-23
• Last updated: 2023-09-25

Locations

1 site across 1 country: Israel