MedTrace Logo

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

NCT04766073 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2023-09-25

No results posted yet for this 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.

Conditions

  • Cesarean Section Complications
  • Uterine Bleeding

Interventions

PROCEDURE

Niche prevention suture

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

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Hila Hochler, MD · Hadassah Medical Organization

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-22
Primary Completion
2024-02-29
Completion
2024-02-29

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04766073 on ClinicalTrials.gov