Ultrasound Based Study For Niche Development In The Uterine Cesarean Section Scar
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| ClinicalTrials.gov Identifier: NCT03859258 |
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Recruitment Status :
Completed
First Posted : March 1, 2019
Last Update Posted : July 22, 2020
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| Tracking Information | ||||||||||
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| 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 |
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
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures |
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| 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. |
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| Study Type | Observational [Patient Registry] | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| 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
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| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
221 | |||||||||
| Original Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 |
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| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | Mohammed Raafat Abdelfatah Mohamed Said, Cairo University | |||||||||
| Study Sponsor | Cairo University | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
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| PRS Account | Cairo University | |||||||||
| Verification Date | July 2020 | |||||||||