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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04687891
Other study ID # 35/2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2020
Est. completion date December 31, 2020

Study information

Verified date July 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

aims to determine the accuracy of measurement of the LUS thickness by trans-abdominal and transvaginal ultrasound at term pregnancy in comparison to the actual thickness of LUS measured with manual caliper measurement during cesarean delivery. Study hypothesis: In women with previous cesarean delivery, determination of the LUS thickness can be done by trans-abdominal and transvaginal ultrasound at term pregnancy and compared to the actual thickness of LUS measured with a manual caliper at cesarean delivery. Study question: considering transabdominal & transvaginal ultrasound, which of them would be more accurate in the assessment of LUS thickness?


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date December 31, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - Age (20:40 years old). - Women at term (37:40 weeks). - With singleton pregnancy. - Presenting by vertex (cephalic presentation). - Having adequate liquor. - Previous delivered by cesarean delivery one time. Exclusion Criteria: - Fetal malformations, e.g fetal hydrops. - Uterine malformations, e.g bicornuate uterus. - Placental malformations, e.g placenta praevia, placenta accrete. - Uterine surgery is other than a cesarean, e.g myomectomy. - Women in labor (painful, regular uterine contractions, cervical dilatation, tender scar, and discomfort is not stopped by sedation). - Obese patients (BMI >30 kg/m2)

Study Design


Intervention

Diagnostic Test:
transabdominal ultrasound and transvaginal ultrasound
Within a week before scheduled delivery,antepartum transabdominal and transvaginal ultrasound will be performed with moderately full bladder.

Locations

Country Name City State
Egypt faculty of medicine - Cairo university Cairo Kasr El Ainy

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary accuracy test for measuring The accuracy of measurement of the LUS thickness by trans-abdominal and transvaginal ultrasound at term pregnancy in comparison to actual thickness of LUS measured with manual caliper at cesarean delivery. 1 week
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