FibroidNCT04736095
3 Dimensional Ultrasound in Comparison to Hysteroscopy in Myomas
An observational study of Fibroid, run by Aljazeera Hospital at 2 sites in Egypt.
Trial summary
three-dimensional saline infusion sonohysterography (3D SIS) was performed in all cases. A sterile Cuscoe speculum was passed, the cervix visualized and cleaned with sterile chlorhexidine solution. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Fibroid
- What is being tested?
- 3D Ultrasound and Hysteroscopy
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 7 Feb 2021to 17 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Women between 20 and 60 years with abnormal uterine bleeding
Who may be able to join
- • Women between 20 and 60 years with abnormal uterine bleeding in form of heavy menstrual bleeding, irregular and heavy menstrual bleeding) diagnosed on non-enhanced two-dimensional ultrasonography with submucous fibroids.
- Absence of STD, PID, active vaginal bleeding.
Who cannot join
- Presence of general cause of abnormal uterine bleeding
- History of drug use that can cause vaginal bleeding (anticoagulants, OCPs, HRT)
- History of recent hormonal treatment
- High risk of undergoing hysteroscopy
- Vaginal, Vulval causes of bleeding
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 3 Dimensional Ultrasound in Comparison to Hysteroscopy in Diagnosis of Myomas
- three-dimensional saline infusion sonohysterography (3D SIS) was performed in all cases. A sterile Cuscoe speculum was passed, the cervix visualized and cleaned with sterile chlorhexidine solution. A 3.3 mm soft plastic paediatric naso-gastric suction catheter was then passed through the cervix into the uterine cavity without grasping the cervix.
Read the detailed description
The speculum was removed and a 5 MHz transvaginal 3D ultrasound probe inserted into the vagina (Voluson 730; KretzTechnik, Austria).
- Conditions
- Fibroid
- Being tested
- 3D Ultrasound, Hysteroscopy
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D UltrasoundDiagnostic test
Doing 3D ultrasound for diagnosis of submucous myoma
HysteroscopyDiagnostic test
Doing hysteroscopy for diagnosis of submucous myoma
| Study group | Role | What they receive |
|---|---|---|
| 3D ultrasound for diagnosis of submucous myomas | Not described Receives: Diagnostic Test: 3D Ultrasound | |
| Hysteroscopy for diagnosis of submucous myoma | Not described Receives: Diagnostic Test: Hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of 3D ultrasound in doiagnosis of submucous myomas in comparison to hysteroscopy
How many women will be diagnosed by 3D US to have submucous myoma
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start7 Feb 2021
- Primary completion15 May 2021
- Study completion17 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, PhD, Study chair, Algezeera hospitaland National Research Centre ,Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736095
- Sponsor's protocol ID
- 3D
- Status last verified
- May 2021
- First submitted
- 29 Jan 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3 Dimensional Ultrasound in Comparison to Hysteroscopy in Diagnosis of Myomas
- ClinicalTrials.gov ID
- NCT04736095
- Acronym / sponsor ID
- 3D
- Conditions
- Fibroid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 7 Feb 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 17 May 2021 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- three-dimensional saline infusion sonohysterography (3D SIS) was performed in all cases. A sterile Cuscoe speculum was passed, the cervix visualized and cleaned with sterile chlorhexidine solution. A 3.3 mm soft plastic paediatric naso-gastric suction catheter was then passed through the cervix into the uterine cavity without grasping the cervix.
Detailed description
The speculum was removed and a 5 MHz transvaginal 3D ultrasound probe inserted into the vagina (Voluson 730; KretzTechnik, Austria).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D ultrasound for diagnosis of submucous myomas | – | Diagnostic Test: 3D Ultrasound |
| Hysteroscopy for diagnosis of submucous myoma | – | Diagnostic Test: Hysteroscopy |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women between 20 and 60 years with abnormal uterine bleeding
Key inclusion criteria (2 listed)
- • Women between 20 and 60 years with abnormal uterine bleeding in form of heavy menstrual bleeding, irregular and heavy menstrual bleeding) diagnosed on non-enhanced two-dimensional ultrasonography with submucous fibroids.
Key exclusion criteria (5 listed)
- Presence of general cause of abnormal uterine bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D UltrasoundDoing 3D ultrasound for diagnosis of submucous myoma | Diagnostic test | 3D ultrasound for diagnosis of submucous myomas |
| HysteroscopyDoing hysteroscopy for diagnosis of submucous myoma | Diagnostic test | Hysteroscopy for diagnosis of submucous myoma |
Primary outcome
The accuracy of 3D ultrasound in doiagnosis of submucous myomas in comparison to hysteroscopy
Time frame: one week
How many women will be diagnosed by 3D US to have submucous myoma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
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Renal Tumor Histology, Cutaneous Leiomyoma
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Life Study: Lifestyle Intervention in Fibroid Elimination
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Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
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Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Alalfy, PhD study chair
Algezeera hospitaland National Research Centre ,Egypt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibroid, run by Aljazeera Hospital at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of 3D ultrasound in doiagnosis of submucous myomas in comparison to hysteroscopy (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.