Mri in Evaluation of Cesarean Section Scar Niche

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03911622
Collaborator
(none)
30
17.1

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Role of Magnetic Resonance Imaging in Evaluation of Uterine Cesarean Section Scar Niche
Anticipated Study Start Date :
Apr 30, 2019
Anticipated Primary Completion Date :
Aug 30, 2020
Anticipated Study Completion Date :
Sep 30, 2020

Outcome Measures

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 [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 [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 [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 [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 [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 [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 [baseline]

    measuring scar depth in mm .

  3. transabdominal and transvaginal ultrasound examination [baseline]

    position in relation to external cervical os and remaining adjacent lower uterine segment

  4. transabdominal and transvaginal ultrasound examination [baseline]

    width in mm

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Gehan Sayed, PHD, Assiut University
  • Study Director: Omran Khodary, MD, Assiut University
  • Study Director: Hisham Abou Taleb, MD, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kero Wagdy, resident doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT03911622
Other Study ID Numbers:
  • MRI in cesarean scar defects
First Posted:
Apr 11, 2019
Last Update Posted:
Apr 11, 2019
Last Verified:
Apr 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 11, 2019