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

NCT04766073 | Unknown

• 1 other identifier: 8978006-HMO-CTIL
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Formation of a uterine niche

  Presence of a uterine niche on ultrasound

  At least 12 weeks after delivery.

Secondary Outcomes (5)

• Duration of surgery

  At surgery

• Blood loss over 1000 mL

  At surgery

• Postoperative infection

  Up to 6 weeks after intervention

• Need for repeat laparotomy

  Up to 6 weeks after intervention

• Formation of a n abscess/hematoma

  Up to 6 weeks after intervention

Study Arms (2)

New Closure Technique

EXPERIMENTAL

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

Procedure: Niche prevention suture

Regular closure technique

NO INTERVENTION

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.

Interventions

Niche prevention suture PROCEDURE

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

New Closure Technique

Eligibility Criteria

• Age: 17 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Uterine Hemorrhage

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hila Hochler, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadas Lemberg, PhD

CONTACT

+972 2 6777572; lhadas@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 23, 2021
• Study Start: July 22, 2021
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)