Uterine Cavity Volume Measuring With Sonohysterography: A New Objective Method

Measuring of uterine cavity volume using sonohysterography will be done in two groups of patients, Group A included 35 patients for home hysterectomy were indicated and group B includes 150 infertile patients in the childbearing age.

Study Overview

• Status: Unknown
• Conditions: Cavity
• Intervention / Treatment: Diagnostic test: sonohysterography

Detailed Description

Uterine cavity volume will be measured in group A before and after hysterectomy, and in the group, B will be measured using sonohysterography only using a mathematical method of the sum of a volume of a cone and part of a sphere.

• Study Type: Observational
• Enrollment (Anticipated): 185

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11357
    • Recruiting
    • Ain shams university maternity hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women undergo sonohysterography for gynecologic indication without gross uterine pathology.

Description

Inclusion Criteria:

1. Patients without any gross pathology within the uterus.
2. Patients admitted for hysterectomy.
3. Patients agreed with written consent to participate in the study.

Exclusion Criteria:

1. Virgins.
2. Pregnancy.
3. Systemic blood disease.
4. Any clinical evidence of cervical, uterine or tubal infection.
5. Refusal to undergo saline infusion sonography.
6. Any gross uterine pathology diagnosed clinically or with sonography.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group A; 35 patients with an indication for hysterectomy without gross uterine pathology	Diagnostic test: sonohysterography; sonohysterography with measuring the uterine cavity volume
group B; 150 infertile patients in the childbearing age without gross uterine pathology	Diagnostic test: sonohysterography; sonohysterography with measuring the uterine cavity volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
calculation of uterine cavity volume with an objective method	measuring uterine cavity volume objectively	one day

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Mohamed I Amer, MD, Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2019
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): January 1, 2020

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (ACTUAL): December 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 23, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: mohamed amer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No