Transabdominal Versus Transvaginal Ultrasound to Assess the Thickness of the Lower Uterine Segment.

July 23, 2021 updated by: ahmed nagy shaker ramadan, Cairo University

Transabdominal Versus Transvaginal Ultrasound to Assess the Thickness of the Lower Uterine Segment at Term in Women With Previous One Cesarean Section.

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Kasr El Ainy
      • Cairo, Kasr El Ainy, Egypt, 11562
        • Faculty of medicine - Cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

130 pregnant women at term with a previous one cesarean section admitted for an elective cesarean delivery will be enrolled. LUS thickness will be measured using both TVS and TAS prior to the cesarean. The actual thickness of the LUS will be measured using a sterile metal ruler before the neonate had been delivered.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy test for measuring
Time Frame: 1 week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

December 24, 2020

First Submitted That Met QC Criteria

December 24, 2020

First Posted (Actual)

December 29, 2020

Study Record Updates

Last Update Posted (Actual)

July 29, 2021

Last Update Submitted That Met QC Criteria

July 23, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 35/2020 (Registry Identifier: Ejercicio multicomponente para mejorar el desempeño físico)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe