Mri in Evaluation of Cesarean Section Scar Niche
April 9, 2019 updated by: Kero Wagdy, Assiut University
Role of Magnetic Resonance Imaging in Evaluation of Uterine Cesarean Section Scar Niche
To evaluate cesarean section scar and the lower uterine segment in non pregnant woman by MRI to :
- 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 .
- development of scoring system and correlating it with the symptoms .
Study Overview
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 Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 41 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Patients attending at out patient clinic complaining from abnormal bleat gynecology department at Assiut university hospitals
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
|
baseline
|
|
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.
|
baseline
|
|
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 .
|
baseline
|
|
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
|
baseline
|
|
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
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
baseline
|
|
transabdominal and transvaginal ultrasound examination
Time Frame: baseline
|
measuring scar depth in mm .
|
baseline
|
|
transabdominal and transvaginal ultrasound examination
Time Frame: baseline
|
position in relation to external cervical os and remaining adjacent lower uterine segment
|
baseline
|
|
transabdominal and transvaginal ultrasound examination
Time Frame: baseline
|
width in mm
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Gehan Sayed, PHD, Assiut University
- Study Director: Omran Khodary, MD, Assiut University
- Study Director: Hisham Abou Taleb, MD, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jastrow N, Irion O, Roberge S, Bujold E. Clinical importance of appearance of cesarean hysterotomy scar at transvaginal ultrasonography in nonpregnant women. Obstet Gynecol. 2011 Jun;117(6):1438. doi: 10.1097/AOG.0b013e31821e24bc. No abstract available.
- Satpathy G, Kumar I, Matah M, Verma A. Comparative accuracy of magnetic resonance morphometry and sonography in assessment of post-cesarean uterine scar. Indian J Radiol Imaging. 2018 Apr-Jun;28(2):169-174. doi: 10.4103/ijri.IJRI_325_17.
- Hoffmann J, Stumpp P, Exner M, Grothoff M, Stepan H. Magnetic resonance imaging as additional diagnostic tool in assessment of lower uterine segment in women with previous Cesarean section. Ultrasound Obstet Gynecol. 2019 Feb;53(2):270-272. doi: 10.1002/uog.19046. No abstract available.
- Wong WSF, Fung WT. Magnetic Resonance Imaging in the Evaluation of Cesarean Scar Defect. Gynecol Minim Invasive Ther. 2018 Jul-Sep;7(3):104-107. doi: 10.4103/GMIT.GMIT_23_18. Epub 2018 Aug 23.
- Gonser M. Re: Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Sep;44(3):371. doi: 10.1002/uog.14631. No abstract available.
- Pomorski M, Fuchs T, Zimmer M. Prediction of uterine dehiscence using ultrasonographic parameters of cesarean section scar in the nonpregnant uterus: a prospective observational study. BMC Pregnancy Childbirth. 2014 Oct 29;14:365. doi: 10.1186/s12884-014-0365-3.
- Kumar I, Verma A, Matah M, Satpathy G. Utility of multiparametric MRI in Caesarean section scar characterization and preoperative prediction of scar dehiscence: a prospective study. Acta Radiol. 2017 Jul;58(7):890-896. doi: 10.1177/0284185116675659. Epub 2016 Oct 31.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 30, 2019
Primary Completion (Anticipated)
August 30, 2020
Study Completion (Anticipated)
September 30, 2020
Study Registration Dates
First Submitted
April 7, 2019
First Submitted That Met QC Criteria
April 9, 2019
First Posted (Actual)
April 11, 2019
Study Record Updates
Last Update Posted (Actual)
April 11, 2019
Last Update Submitted That Met QC Criteria
April 9, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- MRI in cesarean scar defects
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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