Cesarean Section; Dehiscence Clinical Trial
Official title:
A Prospective Controlled Ultrasound Based Study For Niche Development In The Uterine Cesarean Section Scar With Hysteroscopic Correlation In Symptomatizing Patients
NCT number | NCT03859258 |
Other study ID # | CSD1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2017 |
Est. completion date | July 30, 2019 |
Verified date | October 2021 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 221 |
Est. completion date | July 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Niche development in the uterine cesarean section scar | Measure number of patients that will develop uterine Niche following lower segment cesarean section | baseline | |
Secondary | Measuring Residual myometrial thickness (RMT) | Measuring the remaining myometrium above uterine Niche | baseline | |
Secondary | Measuring depth of uterine Niche | Measuring the depth of cesarean scar defect developed after cesarean section | baseline | |
Secondary | Measuring width of uterine Niche | Measuring the width of cesarean scar defect developed after cesarean section | baseline | |
Secondary | Assessment of potential risk factors for Niche development | Detect why Niche develop | baseline | |
Secondary | Rate of postmenstrual spotting in patients with uterine Niche | Measure number of patients having uterine Niche that will complain from postmenstrual spotting | baseline | |
Secondary | Rate of uterine Isthmocele development on hysteroscopic evaluation in patients presenting with postmenstrual spotting after cesarean section | Measure number of patients having uterine Isthmocele detected during hysteroscopic evaluation from all patients presenting with postmenstrual spotting | basline |
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