An observational study in Cesarean Scar Niche, Cesarean Wound; Dehiscence and Cesarean Section; Dehiscence, sponsored by Tanta University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-23.
Sponsored by Tanta University · Observational
This study was designed to evaluate the scar characteristics following scheduled and emergency cesarean deliveries.
design and settings: This study is a descriptive, cross-sectional and multicenter study conducted at Tanta and Benha Universities, Egypt in the period from August, 1, 2018 to December, 31, 2018.
Patients:
Eligibility: Nine hundred patients were selected carefully according to inclusion and exclusion criteria. The inclusion criteria were: (i) Primipara having prior cesarean delivery whether scheduled or emergency (ii) Term delivery ≥ 37 weeks of gestation (iii) Multipara having the last delivery by cesarean either scheduled or emergency (iv) The interval following cesarean delivery to be 6 months at least and (v) Double-layer repair of uterus and (vi) Cesarean by pfannensteil incisions. The exclusion criteria were: (i) Repeat cesarean sections (ii) Preterm delivery (iii) Associated placental abnormalities (iv) Single-layer repair of uterus and (v) Refusal to participate.
Allocations: This study is not a clinical trial so allocation is made based on characteristics of patients and eligibility to be allocated in either scheduled cesarean group or emergency cesarean group. The allocation was not equal based on the percentage of patients in either group. The scheduled cesarean group included 580 cases while the emergency cesarean group included 320 cases from both universities.
Intervention: Cesarean scar assessment included both uterine scar and cutaneous scar. The uterine scar was assessed by transvaginal 3D ultrasound. The used device in both universities was DC-30 device of Mindray Company. All ultrasound examinations were conducted by third author in this study. Cutaneous scar was assessed by surgery department represented by the fourth author in this study. The uterine scar in both groups was examined for distance from internal os, length, thickness, volume, vasculature and presence of any defects. Cutaneous scar was examined for distance from symphysis pubis, length, shape, any depressed areas, any defects (hernia orifice), sinus and presence of keloid or hypertrophic scar.
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's enrollment of 900 is above the median of 353 across 714 observational studies indexed under Emergencies.
Browse Emergencies studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
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All patients will be selected according to inclusion and exclusion criteria.
Exclusion Criteria:
Patient delivered by elective cesarean section without labour pains
Radiation: Ultrasound assessement of uterine scar
Patients delivered by cesarean section due to an emergency
Radiation: Ultrasound assessement of uterine scar
3D ultrasound assessment of scar characteristics
Scar characteristics
Site of scar in relation to internal os of cervix
Time frame: 6 months
Scar length
length of scar in mm
Time frame: 6 months
thickness of scar
Scar depth in mm
Time frame: 6 months
Scar volume
Length multiplied by width multiplied by depth
Time frame: 6 months
Scar vascularity
Doppler on scar to assess vascularity
Time frame: 6 month
Scar defect or niche
Assessment of scar weakness or scar defect by ultrasound with measurement of depth, width and length of defects plus the residual myometrial tissue
Time frame: 6 months
Plan to share: No — Individual participant data (IPD) are secret
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Tanta University