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

Hadassah Medical Center

Status: Enrolling

Conditions: Uterine Bleeding; Cesarean Section Complications

Treatments: Procedure: Niche prevention suture

Study type: Interventional

Funder types: Other

Identifiers

NCT04766073

8978006-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 183 estimated patients

Sex: Female

Ages: 17 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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183 participants in 2 patient groups

New Closure Technique

Experimental group

Description:

This group will have the uterus closed after delivery of the fetus during cesarean section with a new technique.

Treatment:

Procedure: Niche prevention suture

Regular closure technique

No Intervention group

Description:

The usual method of closing the surgical incision is to suture the entire wall of the uterus with a stratafix suture without locking the suture.