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Mri in Evaluation of Cesarean Section Scar Niche

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ClinicalTrials.gov Identifier: NCT03911622
Recruitment Status : Unknown
Verified April 2019 by Kero Wagdy, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Kero Wagdy, Assiut University

Study Description
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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 .

Condition or disease Intervention/treatment
Cesarean Section; Dehiscence Device: MRI

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 .

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Magnetic Resonance Imaging in Evaluation of Uterine Cesarean Section Scar Niche
Estimated Study Start Date : April 30, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: MRI
    medical device that is used as an imaging tool for soft tissues

Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    • Pre-designated standard protocols were followed consisting of T1-weighted (T1W) and T2-weighted (T2W) imaging sequences in axial and sagittal planes remaining perpendicular to the long axis of the scar
    • The scar site will be identified as the thinnest portion of LUS and having the lowest signal intensity on T2W imaging.

  2. 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 position will be evaluated using relative distance in mm from inferior boundary of scar to external cervix os, which will be measured by curve distance in mm along the endometrium and cervical inner surface.

  3. 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 thickness in mm will be calculated at the site of the scar .

  4. 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 ]
    Presence of endometrium adjacent to scar will be recorded

  5. 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 Outcome Measures :
  1. clinical evaluation [ Time Frame: baseline ]
    asking patients about clinical symptoms like postmenstrual spotting , secondary infertility and chronic pelvic pain in order to correlate them with the scar criteria collected by MRI

  2. transabdominal and transvaginal ultrasound examination [ Time Frame: baseline ]
    measuring scar depth in mm .

  3. transabdominal and transvaginal ultrasound examination [ Time Frame: baseline ]
    position in relation to external cervical os and remaining adjacent lower uterine segment

  4. transabdominal and transvaginal ultrasound examination [ Time Frame: baseline ]
    width in mm


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients attending at out patient clinic complaining from abnormal bleat gynecology department at Assiut university hospitals
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Post menopausal women .
  2. hysterectomy .
  3. Presence of other gynecological disease like endometriosis , uterine fibroids .
  4. any general contraindication to MRI as presence of any paramagnetic substance as pacemakers or in severely ill patients or those with claustrophobia, arrhythmic patients .
  5. intrauterine devices .
  6. bleeding tendency.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03911622


Contacts
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Contact: kerolos wagdy 01284296866 kerowagdy25@gmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Gehan Sayed, PHD Assiut University
Study Director: Omran Khodary, MD Assiut University
Study Director: Hisham Abou Taleb, MD Assiut University
More Information
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Publications:

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Responsible Party: Kero Wagdy, resident doctor, Assiut University
ClinicalTrials.gov Identifier: NCT03911622    
Other Study ID Numbers: MRI in cesarean scar defects
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No