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

NCT ID: NCT04766073

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-22
• Study Completion Date: 2024-02-29

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.

Conditions

Cesarean Section Complications; Uterine Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

New Closure Technique

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

Group Type: EXPERIMENTAL

Niche prevention suture

Intervention Type: PROCEDURE

This group will have the uterus sutured in two layers using a new technique.

Regular closure technique

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Niche prevention suture

This group will have the uterus sutured in two layers using a new technique.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hila Hochler, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Hadas Lemberg, PhD

Role: CONTACT

lhadas@hadassah.org.il

+972 2 6777572

Facility Contacts

Hadass Lemberg, PhD

Role: primary

lhadas@hadassah.org.il

+972 2 6777572

Other Identifiers

8978006-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id