Clinical Trials Directory

Trials / Completed

CompletedNCT03609281

Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries

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

Status
Completed
Phase
Study type
Observational
Enrollment
900 (actual)
Sponsor
Tanta University · Academic / Other
Sex
Female
Age
20 Years – 35 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
RADIATIONUltrasound assessement of uterine scar3D ultrasound assessment of scar characteristics

Timeline

Start date
2018-08-01
Primary completion
2019-03-31
Completion
2019-03-31
First posted
2018-08-01
Last updated
2019-04-23

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03609281. Inclusion in this directory is not an endorsement.