Mri in Evaluation of Cesarean Section Scar Niche

NCT ID: NCT03911622

Last Updated: 2019-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-30

Study Completion Date

2020-09-30

Brief Summary

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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 .

Detailed Description

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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 .

Conditions

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Cesarean Section; Dehiscence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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MRI

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Kero Wagdy

resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gehan Sayed, PHD

Role: STUDY_CHAIR

Assiut University

Omran Khodary, MD

Role: STUDY_DIRECTOR

Assiut University

Hisham Abou Taleb, MD

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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kerolos wagdy

Role: CONTACT

01284296866

References

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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.

Reference Type BACKGROUND
PMID: 21606763 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30050239 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29532537 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30254950 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25154489 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25733122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27799572 (View on PubMed)

Other Identifiers

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MRI in cesarean scar defects

Identifier Type: -

Identifier Source: org_study_id

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