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

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: Trans Abdominal Ultrasound; Transvaginal Ultrasound; Lower Uterine Segment Thickness
• Intervention / Treatment: Diagnostic test: transabdominal ultrasound and transvaginal ultrasound

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

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

Participation Criteria

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

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	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

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Nagy Afifi A, Ahmed Taymour M, Mamdouh El-Khayat W. Transabdominal versus transvaginal ultrasound to assess the thickness of lower uterine segment at term in women with previous cesarean section. Eur J Obstet Gynecol Reprod Biol. 2022 Apr;271:145-151. doi: 10.1016/j.ejogrb.2022.01.027. Epub 2022 Feb 7.

Study record dates

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