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

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.

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section Complications; Uterine Bleeding
• Intervention / Treatment: Procedure: Niche prevention suture

• Study Type: Interventional
• Enrollment (Estimated): 183
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hadas Lemberg, PhD; Phone Number: +972 2 6777572; Email: lhadas@hadassah.org.il

Study Locations

• Israel
  • Jerusalem, Israel
    • Recruiting
    • Hadassah Medical Organization
    • Contact: Hadass Lemberg, PhD; Phone Number: +972 2 6777572; Email: lhadas@hadassah.org.il
    • Principal Investigator: Hila Hochler, MD
    • Sub-Investigator: Simcha Yagel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New Closure Technique; This group will have the uterus closed after delivery of the fetus during cesarean section with a new technique.	Procedure: Niche prevention suture; This group will have the uterus sutured in two layers using a new technique.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Formation of a uterine niche	Presence of a uterine niche on ultrasound	At least 12 weeks after delivery.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Hila Hochler, MD, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2021
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 21, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Wounds and Injuries; Hemorrhage; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Surgical Wound; Uterine Hemorrhage
• Other Study ID Numbers: 8978006-HMO-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No