Ayman Shehata Dawood
Tanta, Algharbia, 31111, Egypt
NCT Number: NCT03609281
This study was designed to evaluate the scar characteristics following scheduled and emergency cesarean deliveries.
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Notify Me20 year–35 year
Female
Observational
Tanta, Algharbia, 31111, Egypt
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3D ultrasound assessment of scar characteristics
Time frame: 6 months
Site of scar in relation to internal os of cervix
Time frame: 6 months
length of scar in mm
Time frame: 6 months
Scar depth in mm
Time frame: 6 months
Length multiplied by width multiplied by depth
Time frame: 6 month
Doppler on scar to assess vascularity
Time frame: 6 months
Assessment of scar weakness or scar defect by ultrasound with measurement of depth, width and length of defects plus the residual myometrial tissue
Tanta University
Other
Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries: A Single Center Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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