Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries
- Conditions
- Cesarean Scar NicheCesarean Wound; DehiscenceCesarean Section; Dehiscence
- Interventions
- Radiation: Ultrasound assessement of uterine scar
- Registration Number
- NCT03609281
- Lead Sponsor
- Tanta University
- Brief Summary
This study was designed to evaluate the scar characteristics following scheduled and emergency cesarean deliveries.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 900
- Primipara delivered by cs
- Multipara with last delivery by cs
- Full term delivery >37 weeks
- Double layer cesarean repair
- Pfannenstiel incison
- Repeat cs
- Any placental abnormalities
- Preterm delivery
- Single layer cesarean repair
- Refusal to participate
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Scheduled cesaren group Ultrasound assessement of uterine scar Patient delivered by elective cesarean section without labour pains Emergency cesarean group Ultrasound assessement of uterine scar Patients delivered by cesarean section due to an emergency
- Primary Outcome Measures
Name Time Method Scar length 6 months length of scar in mm
thickness of scar 6 months Scar depth in mm
Scar vascularity 6 month Doppler on scar to assess vascularity
Scar characteristics 6 months Site of scar in relation to internal os of cervix
Scar volume 6 months Length multiplied by width multiplied by depth
- Secondary Outcome Measures
Name Time Method Scar defect or niche 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
Trial Locations
- Locations (1)
Ayman Shehata Dawood
🇪🇬Tanta, Algharbia, Egypt