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

Not Applicable

Recruiting

• Conditions: Cesarean Section Complications; Uterine Bleeding
• Interventions: Procedure: Niche prevention suture

• Registration Number: NCT04766073
• Lead Sponsor: Hadassah Medical Organization

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-21
• Study First Posted: 2021-02-23
• Study Start: 2021-07-22
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 183

Inclusion Criteria

• Women at first cesarean delivery
• Women who consent to the study

Exclusion Criteria

• Women who are having a repeat caesarean section
• Refusal to participate in the study
• Urgent or emergent cesarean delivery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New Closure Technique	Niche prevention suture	This group will have the uterus closed after delivery of the fetus during cesarean section with a new technique.

Primary Outcome Measures

Name	Time	Method
Formation of a uterine niche	At least 12 weeks after delivery.	Presence of a uterine niche on ultrasound

Secondary Outcome Measures

Name	Time	Method
Blood loss over 1000 mL	At surgery	As assessed by the operating surgeon
Need for repeat laparotomy	Up to 6 weeks after intervention	The number of patients who undergo a repeat laparotomy after the initial cesarean delivery will be ascertained.
Duration of surgery	At surgery	Total duration of surgery
Postoperative infection	Up to 6 weeks after intervention	The number of patients who are diagnosed with postoperative infection including endometritis or wound infection.
Formation of a n abscess/hematoma	Up to 6 weeks after intervention	The number of patients who are diagnosed with a pelvic abscess or hematoma from the time of the cesarean delivery until 6 weeks after the cesarean delivery.

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel