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

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ClinicalTrials.gov Identifier: NCT03859258
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Mohammed Raafat Abdelfatah Mohamed Said, Cairo University

Tracking Information
First Submitted Date February 26, 2019
First Posted Date March 1, 2019
Last Update Posted Date July 22, 2020
Actual Study Start Date July 1, 2017
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 27, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 27, 2019)
  • Measuring Residual myometrial thickness (RMT) [ Time Frame: baseline ]
    Measuring the remaining myometrium above uterine Niche
  • Measuring depth of uterine Niche [ Time Frame: baseline ]
    Measuring the depth of cesarean scar defect developed after cesarean section
  • Measuring width of uterine Niche [ Time Frame: baseline ]
    Measuring the width of cesarean scar defect developed after cesarean section
  • Assessment of potential risk factors for Niche development [ Time Frame: baseline ]
    Detect why Niche develop
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ultrasound Based Study For Niche Development In The Uterine Cesarean Section Scar
Official Title A Prospective Controlled Ultrasound Based Study For Niche Development In The Uterine Cesarean Section Scar With Hysteroscopic Correlation In Symptomatizing Patients
Brief Summary 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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pregnant women
Condition Cesarean Section; Dehiscence
Intervention Device: Transvaginal sonography
Niche is assessed using TVS, SIS and office hysteroscopy
Other Name: SIS, office hysteroscopy
Study Groups/Cohorts
  • Patient having Cesarean section
    Transvaginal sonography for patients having ceserean section to assess uterine Niche development and parameters
    Intervention: Device: Transvaginal sonography
  • Patient delivered vaginally
    Transvaginal sonography for patients having vaginal delivery to confirm absence of uterine Niche development
    Intervention: Device: Transvaginal sonography
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 21, 2020)
221
Original Estimated Enrollment
 (submitted: February 27, 2019)
200
Actual Study Completion Date July 30, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Delivered by Lower segment cesarean section
  2. Singleton fetus
  3. Living fetus
  4. 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03859258
Other Study ID Numbers CSD1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Mohammed Raafat Abdelfatah Mohamed Said, Cairo University
Study Sponsor Cairo University
Collaborators Not Provided
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
PRS Account Cairo University
Verification Date July 2020