Mri in Evaluation of Cesarean Section Scar Niche

• Conditions: Cesarean Section; Dehiscence

• Registration Number: NCT03911622
• Lead Sponsor: Assiut University

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 .

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 Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-07
• Study First Submitted QC: 2019-04-09
• Last Update Submitted: 2019-04-09
• Study First Posted: 2019-04-11
• Last Update Posted: 2019-04-11
• Study Start: 2019-04-30
• Primary Completion: 2020-08-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
transabdominal and transvaginal ultrasound examination	baseline	width in mm
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