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Clinical Trials/NCT03911622
NCT03911622
Unknown
Not Applicable

Role of Magnetic Resonance Imaging in Evaluation of Uterine Cesarean Section Scar Niche

Assiut University0 sites30 target enrollmentApril 30, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cesarean Section; Dehiscence
Sponsor
Assiut University
Enrollment
30
Primary Endpoint
MRI pelvis examination (sagittal T2WI ) using 1.5 tesla system Torso phased-array body coil with the patient in the supine position and a moderately full urinary bladder
Last Updated
7 years ago

Overview

Brief Summary

To evaluate cesarean section scar and the lower uterine segment in non pregnant woman by MRI to :

  1. Assess the clinical symptoms like postmenstrual spotting or prolonged menstrual bleeding, dysmenorrhea, chronic pelvic pain and dyspareunia and its relation to the presence of cesarean scar defects and its characteristics .
  2. development of scoring system and correlating it with the symptoms .

Detailed Description

With increasing cesarean section rate nowadays, the risks of cesarean scar defect (CSD) should increase. CSD is defined by ultrasound imaging as a triangular hypoechoic defect in the myometrium at the site of the previous cesarean section scar. However, patients with CSD are sometimes asymptomatic. Yet, some patients with CSD can have symptoms of abnormal uterine bleeding, pelvic pain, infertility, uterine rupture, and potential risks of adverse pregnancy outcome .There is an association between the size of a niche and postmenstrual spotting. women with a history of CS, the depth and shape of the niche were not significant factors, while a larger niche volume was described in women with postmenstrual spotting. in women with gynecological symptoms, the niches were significantly wider in women with postmenstrual spotting, dysmenorrhea or chronic pelvic pain, and the prevalence of postmenstrual spotting or prolonged menstrual bleeding was higher with a larger diameter of the niche .Magnetic resonance imaging (MRI) has recently shown a promise tool for evaluation of uterine scar thickness. As opposed to ultrasonography (USG), which is the current gold standard for this purpose, MRI reduces observer dependence and has a superior multiplanar capability. MRI can be used for assessment of lower uterine segment. It provides accurate tissue characterization, independent of patient body mass index .

Registry
clinicaltrials.gov
Start Date
April 30, 2019
End Date
September 30, 2020
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kero Wagdy

resident doctor

Assiut University

Eligibility Criteria

Inclusion Criteria

  • previous lower uterine segment cesarean section before .
  • At least 6 months after the last cesarean section .
  • still regularly menstruating .
  • Absence of other gynecological disease or intrauterine lesions like endometriosis , uterine fibroid .

Exclusion Criteria

  • Post menopausal women .
  • hysterectomy .
  • Presence of other gynecological disease like endometriosis , uterine fibroids .
  • any general contraindication to MRI as presence of any paramagnetic substance as pacemakers or in severely ill patients or those with claustrophobia, arrhythmic patients .
  • intrauterine devices .
  • bleeding tendency.

Outcomes

Primary Outcomes

MRI pelvis examination (sagittal T2WI ) using 1.5 tesla system Torso phased-array body coil with the patient in the supine position and a moderately full urinary bladder

Time Frame: baseline

Scar shape were classified as "U" shape, "V" shape and mixed shape, judging from the transitional region from scar to normal uterine or cervical wal

Secondary Outcomes

  • transabdominal and transvaginal ultrasound examination(baseline)
  • clinical evaluation(baseline)

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