NCT03777566

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
185

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 10, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

December 23, 2019

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

December 14, 2018

Last Update Submit

December 20, 2019

Conditions

Cavity

Outcome Measures

Primary Outcomes (1)

  • calculation of uterine cavity volume with an objective method

    measuring uterine cavity volume objectively

    one day

Study Arms (2)

group A

35 patients with an indication for hysterectomy without gross uterine pathology

Diagnostic Test: sonohysterography

group B

150 infertile patients in the childbearing age without gross uterine pathology

Diagnostic Test: sonohysterography

Interventions

sonohysterographyDIAGNOSTIC_TEST

sonohysterography with measuring the uterine cavity volume

group Agroup B

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women undergo sonohysterography for gynecologic indication without gross uterine pathology.

You may qualify if:

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

You may not qualify if:

  • Virgins.
  • Pregnancy.
  • Systemic blood disease.
  • Any clinical evidence of cervical, uterine or tubal infection.
  • Refusal to undergo saline infusion sonography.
  • Any gross uterine pathology diagnosed clinically or with sonography.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIn Shams University Maternity Hospital

Cairo, 11357, Egypt

RECRUITING

Study Officials

  • Mohamed I Amer, MD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed I Amer, MD

CONTACT

00201001519370mohamed_amer810@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 14, 2018

First Posted

December 17, 2018

Study Start

February 10, 2019

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

December 23, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)