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Completed

NCT Number: NCT03609281

Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries

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

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Ayman Shehata Dawood

Tanta, Algharbia, 31111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound assessement of uterine scar

Radiation

3D ultrasound assessment of scar characteristics

Primary outcomes

  1. Scar characteristics

    Time frame: 6 months

    Site of scar in relation to internal os of cervix

  2. Scar length

    Time frame: 6 months

    length of scar in mm

  3. thickness of scar

    Time frame: 6 months

    Scar depth in mm

  4. Scar volume

    Time frame: 6 months

    Length multiplied by width multiplied by depth

  5. Scar vascularity

    Time frame: 6 month

    Doppler on scar to assess vascularity

Secondary outcomes

  1. Scar defect or niche

    Time frame: 6 months

    Assessment of scar weakness or scar defect by ultrasound with measurement of depth, width and length of defects plus the residual myometrial tissue

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2018
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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