Ultrasound Based Study For Niche Development In The Uterine Cesarean Section Scar

October 9, 2021 updated by: Mohammed Raafat Abdelfatah Mohamed Said, Cairo University

A Prospective Controlled Ultrasound Based Study For Niche Development In The Uterine Cesarean Section Scar With Hysteroscopic Correlation In Symptomatizing Patients

The aim of this study is to evaluate different factors affecting niche development in the uterine cesarean section scar in women enrolled 3 to 6 months after cesarean delivery using both TVS and SIS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cesarean delivery is amongst the most widely recognized operations performed on women and its rate continue expanding. The rates of cesarean section (CS) in the United States in 1996 and 2009 were 20.7% and 32.3% respectively, witnessing an expansion of more than half. In China, 50% of deliveries in 2010 were through CS. In the Netherlands, the cesarean delivery rate jumped from 7.4 to 15.8% between 1990 and 2008, whereas in the United Kingdom, the CS rate increased from 12 to 29% throughout the same time period. In Brazil, the CS rate jumped from 15% in 1970 to even 80% in 2004.

The expanding rate of cesarean deliveries can be credited to many variables including an increase in repeated cesarean sections. There is no discourse that CS is a lifesaving method for a few women, for instance for women with placenta previa or obstructed labor, or for fetuses with either antenatal or intrapartum distress, breech pregnancy or a twin pregnancy. The World Health Organization suggests that the ideal CS rate should be 15%.

Also, this expanding CS rate has fortified an enthusiasm for the potential long-term morbidity of CS scars. By and large, the cesarean incision heals uneventfully. However, some authors depicted a cesarean scar defect on transvaginal sonography (TVS) or saline infusion sonography (SIS) as a wedge shape anechoic structure at the site of the scar or a gap in anterior myometrium of the anterior lower myometrium at the site of previous cesarean section site. This was first described using hysterosalpingography in 1961. The terminology used to describe these scar abnormalities include scar defects, or 'niches' in the uterine scar, cesarean scar defect, uterine diverticulum, uterine isthmocele, pouch or sacculation and differs various publications. The term 'niche', which was introduced in 2001. A niche appears to be frequently present after a CS. Using SIS, niches were identified in the scar in more than half of the women who had had a caesarean delivery. Niches were defined as indentations of the myometrium of at least 2 mm. Large niches occur less frequently, with an incidence varying from 11 to 45% dependent on the definition used (a depth of at least 50 or 80% of the anterior myometrium, or the remaining myometrial thickness ≤2.2 mm when evaluated by TVS and ≤2.5 mm when evaluated by sonohysterography).

It is usually asymptomatic. Be that as it may, some authors have described some symptoms identified with this condition and there are several studies relating abnormal uterine bleeding and niche, especially postmenstrual spotting which appears to be the most common symptom in women with niches due to the collection of menstrual blood in a uterine scar defect causing postmenstrual spotting.

Later prospective cohort studies reported spotting in ∼30% of women with a niche at 6- 12 months after their CS compared with 15% of women without a niche after CS. It is undoubtedly a generally new pathology that needs assessment.

Study Type

Observational

Enrollment (Actual)

221

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 113411
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women

Description

Inclusion Criteria:

  1. Cases are delivered by Lower segment cesarean section
  2. Controls are delivered vaginally
  3. Singleton fetus
  4. Living fetus
  5. Term pregnancy

Exclusion Criteria:

  1. Placenta praevia
  2. Congenital fetal anomalies
  3. Severe oligohydramnios(MVP <2cm)
  4. Rupture of membranes more than 18 hours
  5. Puerperal pyrexia or sepsis
  6. Bladder injury
  7. Blood transfusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient having Cesarean section
Transvaginal sonography for patients having ceserean section to assess uterine Niche development and parameters
Device: Transvaginal sonography
Niche is assessed using TVS, SIS (cases only) and office hysteroscopy
Other Names:
  • SIS, office hysteroscopy
Patient delivered vaginally
Transvaginal sonography for patients having vaginal delivery to confirm absence of uterine Niche development
Device: Transvaginal sonography
Niche is assessed using TVS, SIS (cases only) and office hysteroscopy
Other Names:
  • SIS, office hysteroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Niche development in the uterine cesarean section scar
Time Frame: baseline
Measure number of patients that will develop uterine Niche following lower segment cesarean section
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring Residual myometrial thickness (RMT)
Time Frame: baseline
Measuring the remaining myometrium above uterine Niche
baseline
Measuring depth of uterine Niche
Time Frame: baseline
Measuring the depth of cesarean scar defect developed after cesarean section
baseline
Measuring width of uterine Niche
Time Frame: baseline
Measuring the width of cesarean scar defect developed after cesarean section
baseline
Assessment of potential risk factors for Niche development
Time Frame: baseline
Detect why Niche develop
baseline
Rate of postmenstrual spotting in patients with uterine Niche
Time Frame: baseline
Measure number of patients having uterine Niche that will complain from postmenstrual spotting
baseline
Rate of uterine Isthmocele development on hysteroscopic evaluation in patients presenting with postmenstrual spotting after cesarean section
Time Frame: basline
Measure number of patients having uterine Isthmocele detected during hysteroscopic evaluation from all patients presenting with postmenstrual spotting
basline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mona M Aboulghar, M.D., Cairo University
  • Principal Investigator: Hassan M Gaafar, M.D., Cairo University
  • Principal Investigator: Hisham M Haggag, M.D., Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ACTUAL)

June 30, 2019

Study Completion (ACTUAL)

July 30, 2019

Study Registration Dates

First Submitted

February 26, 2019

First Submitted That Met QC Criteria

February 27, 2019

First Posted (ACTUAL)

March 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 18, 2021

Last Update Submitted That Met QC Criteria

October 9, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • CSD1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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