Mri in Evaluation of Cesarean Section Scar Niche

NCT03911622 | Unknown

• 1 other identifier: MRI in cesarean scar defects
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

1. 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. 2.development of scoring system and correlating it with the symptoms .

Conditions

Cesarean Section; Dehiscence

Outcome Measures

Primary Outcomes (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

  * 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.

  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

  \- 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

  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

  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

  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 Outcomes (4)

• clinical evaluation

  baseline

• transabdominal and transvaginal ultrasound examination

  baseline

• transabdominal and transvaginal ultrasound examination

  baseline

• transabdominal and transvaginal ultrasound examination

  baseline

Interventions

MRI DEVICE

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 21606763 BACKGROUND

• 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.

  PMID: 30050239 BACKGROUND

• 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.

  PMID: 29532537 BACKGROUND

• 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.

  PMID: 30254950 BACKGROUND

• 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.

  PMID: 25154489 BACKGROUND

• 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.

  PMID: 25733122 BACKGROUND

• 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.

  PMID: 27799572 BACKGROUND

Study Officials

• Gehan Sayed, PHD

  Assiut University

  STUDY CHAIR

• Omran Khodary, MD

  Assiut University

  STUDY DIRECTOR

• Hisham Abou Taleb, MD

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

kerolos wagdy

CONTACT

01284296866; kerowagdy25@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: April 7, 2019
• First Posted: April 11, 2019
• Study Start: April 30, 2019
• Primary Completion: August 30, 2020
• Study Completion: September 30, 2020
• Last Updated: April 11, 2019

Record last verified: 2019-04