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

Last updated: September 22, 2023
Sponsor: Hadassah Medical Organization
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pressure Ulcer

Uterine Disorders

Treatment

Niche prevention suture

Clinical Study ID

NCT04766073
8978006-HMO-CTIL
  • Ages 17-50
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 183
Treatment Group(s): 1
Primary Treatment: Niche prevention suture
Phase:
Study Start date:
July 22, 2021
Estimated Completion Date:
February 29, 2024

Connect with a study center

  • Hadassah Medical Organization

    Jerusalem,
    Israel

    Active - Recruiting

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