Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries

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

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Dehiscence; Cesarean Wound; Dehiscence; Cesarean Scar Niche
• Intervention / Treatment: Radiation: Ultrasound assessement of uterine scar

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.

• Study Type: Observational
• Enrollment (Actual): 900

Contacts and Locations

Study Locations

• Egypt
  • Algharbia
    • Tanta, Algharbia, Egypt, 31111
      • Ayman Shehata Dawood

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All patients will be selected according to inclusion and exclusion criteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Scheduled cesaren group; Patient delivered by elective cesarean section without labour pains	Radiation: Ultrasound assessement of uterine scar; 3D ultrasound assessment of scar characteristics
Emergency cesarean group; Patients delivered by cesarean section due to an emergency	Radiation: Ultrasound assessement of uterine scar; 3D ultrasound assessment of scar characteristics

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): March 31, 2019
• Study Completion (ACTUAL): March 31, 2019

Study Registration Dates

• First Submitted: July 15, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (ACTUAL): August 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 20, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: Ayman CS Scar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) are secret

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No