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Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries

T

Tanta University

Status

Completed

Conditions

Cesarean Section; Dehiscence
Cesarean Scar Niche
Cesarean Wound; Dehiscence

Treatments

Radiation: Ultrasound assessement of uterine scar

Study type

Observational

Funder types

Other

Identifiers

NCT03609281
Ayman CS Scar

Details and patient eligibility

About

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

Full 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.

Enrollment

900 patients

Sex

Female

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

900 participants in 2 patient groups

Scheduled cesaren group
Description:
Patient delivered by elective cesarean section without labour pains
Treatment:
Radiation: Ultrasound assessement of uterine scar
Emergency cesarean group
Description:
Patients delivered by cesarean section due to an emergency
Treatment:
Radiation: Ultrasound assessement of uterine scar

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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