Transvaginal Ultrasound Clinical Trial
Official title:
Transabdominal Versus Transvaginal Ultrasound to Assess the Thickness of the Lower Uterine Segment at Term in Women With Previous One Cesarean Section.
| 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 |
| Verified date | July 2021 |
| Source | Cairo University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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?
| 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) |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | faculty of medicine - Cairo university | Cairo | Kasr El Ainy |
| Lead Sponsor | Collaborator |
|---|---|
| Cairo University |
Egypt,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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