Clinical trial NCT03609281: Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries
Official title: Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries: A Single Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Scar Niche
Cesarean Wound; Dehiscence
Cesarean Section; Dehiscence
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 900
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients will be selected according to inclusion and exclusion criteria.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Scar characteristics
timeFrame: 6 months
measure: Scar length
timeFrame: 6 months
measure: thickness of scar
timeFrame: 6 months
measure: Scar volume
timeFrame: 6 months
measure: Scar vascularity
timeFrame: 6 month
Secondary outcomes:
measure: Scar defect or niche
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Ayman Shehata Dawood
state: Algharbia
Study officials:
References: