Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries

Study Overview
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Brief Summary
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This study was designed to evaluate the scar characteristics following scheduled and emergency cesarean deliveries.

Detailed Description
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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.

Official Title
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Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries: A Single Center Study

Conditions
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Cesarean Scar Niche, Cesarean Wound; Dehiscence, Cesarean Section; Dehiscence

Intervention / Treatment
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* Radiation: Ultrasound assessement of uterine scar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primipara delivered by cs Multipara with last delivery by cs Full term delivery >37 weeks Double layer cesarean repair Pfannenstiel incison Exclusion Criteria: Repeat cs Any placental abnormalities Preterm delivery Single layer cesarean repair Refusal to participate

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Scheduled cesaren group<br>Patient delivered by elective cesarean section without labour pains | Radiation: Ultrasound assessement of uterine scar<br>* 3D ultrasound assessment of scar characteristics<br>|
| Emergency cesarean group<br>Patients delivered by cesarean section due to an emergency | Radiation: Ultrasound assessement of uterine scar<br>* 3D ultrasound assessment of scar characteristics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar characteristics | Site of scar in relation to internal os of cervix | 6 months | 
| Scar length | length of scar in mm | 6 months | 
| thickness of scar | Scar depth in mm | 6 months | 
| Scar volume | Length multiplied by width multiplied by depth | 6 months | 
| Scar vascularity | Doppler on scar to assess vascularity | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months |