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Cesarean Section; DehiscenceNCT03911622

Mri in Evaluation of Cesarean Section Scar Niche

An observational study of Cesarean Section; Dehiscence, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Cesarean Section; Dehiscence
What is being tested?
MRI
Type of treatment
Medical device
How many people
30 participants
Where
No sites listed yet
Study dates
30 Apr 2019to 30 Sep 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Patients attending at out patient clinic complaining from abnormal bleat gynecology department at Assiut university hospitals

Who may be able to join

  • 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 .

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

kerolos wagdy contact

01284296866

kerowagdy25@gmail.com

About this study

Official title: 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 :

  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 .
Read the 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 .

Being tested
MRI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRIDevice

    medical device that is used as an imaging tool for soft tissues

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    • 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.

    Measured: baseline

  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

    • 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.

    Measured: baseline

  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

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

    Measured: baseline

  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

    Presence of endometrium adjacent to scar will be recorded

    Measured: baseline

  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

    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

    Measured: baseline

Secondary outcomes (4)

  1. clinical evaluation

    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

    Measured: baseline

  2. transabdominal and transvaginal ultrasound examination

    measuring scar depth in mm .

    Measured: baseline

  3. transabdominal and transvaginal ultrasound examination

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

    Measured: baseline

  4. transabdominal and transvaginal ultrasound examination

    width in mm

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2019
  2. Study start30 Apr 2019 (estimated)
  3. Primary completion30 Aug 2020 (estimated)
  4. Study completion30 Sep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03911622
Sponsor's protocol ID
MRI in cesarean scar defects
Status last verified
Apr 2019
First submitted
7 Apr 2019
Last updated
11 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 21606763

  • 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.

    PubMed 30050239

  • 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.

    PubMed 29532537

  • 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.

    PubMed 30254950

  • 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.

    PubMed 25154489

  • 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.

    PubMed 25733122

  • 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.

    PubMed 27799572

Questions about this trial

What is this clinical trial studying?

An observational study of Cesarean Section; Dehiscence, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact kerolos wagdy (01284296866, kerowagdy25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03911622, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.

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