Uterine Cavity Volume Measuring With Sonohysterography: A New Objective Method

• Sponsor: Ain Shams University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03777566
• Collaborator: (none)
• Enrollment: 185
• Location: 1
• Anticipated Duration (Months): 10.7
• Patients Per Site Per Month: 17.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cavity	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 185 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Uterine Cavity Volume Measuring With Sonohysterography: A New Objective Method
• Actual Study Start Date: Feb 10, 2019
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. calculation of uterine cavity volume with an objective method [one day]

   measuring uterine cavity volume objectively

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AIn Shams University Maternity Hospital	Cairo		Egypt	11357

Sponsors and Collaborators

• Ain Shams University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed I Amer, Professor, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03777566
• Other Study ID Numbers: mohamed amer
• First Posted: Dec 17, 2018
• Last Update Posted: Dec 23, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 23, 2019