Abnormal Uterine BleedingNCT03441087
The Role of TVSG and HS in Determining Endometrial Pathologies
A study testing Transvaginal ultrasound and Hysteroscopy in people with Abnormal Uterine Bleeding, run by Sisli Hamidiye Etfal Training and Research Hospital.
Trial summary
Although hysteroscopy (HS) and transvaginal ultrasonography (TVSG) are methods in the diagnosis of AUB, there is some suspicion about their efficacy. The aim of this study was to determine the efficacy and safety of HS and TVSG on diagnosing abnormal uterine bleeding(AUB) .216 women admitted to the investigators… Read more about this study
- Who is it for?
- Ages 21 to 51 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abnormal Uterine Bleeding
- What is being tested?
- Transvaginal ultrasound and Hysteroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Dec 2011
- Phase
- Interventional
- 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 21 to 51 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients who have no history of hysteroscopy and curettage,
- patients who have no history of ovulatory dysfunction
- women who have active vaginal bleeding.
Who cannot join
- presence of genital infections/PID
- presence of pregnancy
- presence of vaginal or cervical pathology causing vaginal bleeding
- women who are receiving hormonal treatment (COC/HRT)
- patients formerly diagnosed with endometrial pathology
- patients having coagulopathy
- women who are using intrauterine device.
About this study
Official title: Ultrasound and Hysteroscopy's Place on the Diagnosis of Abnormal Uterin Bleeding
Although hysteroscopy (HS) and transvaginal ultrasonography (TVSG) are methods in the diagnosis of AUB, there is some suspicion about their efficacy. The aim of this study was to determine the efficacy and safety of HS and TVSG on diagnosing abnormal uterine bleeding(AUB) .216 women admitted to the investigators clinic (Sisli Ethal Training and Research Hospital, Obstetrics and Gynecology Department Obstetrics Service ) between 21-51 years of age. These patients were divided into two groups; menopause (71women) and pre-menopause (145 women). HS and endometrial sampling were performed both groups after TVSG.The success of these methods was assessed by kappa analysis
- Conditions
- Abnormal Uterine Bleeding
- Being tested
- Transvaginal ultrasound, Hysteroscopy
- Keywords
- transvaginal ultrasonography, hysteroscopy, abnormal uterine bleeding
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasoundDevice
HysteroscopyDevice
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal ultrasound | Other | Transvaginal ultrasound was applied 216 women with abnormal uterine bleeding.The transvaginal ultrasound diagnoses were compared with the received endometrial samples. Receives: Device: Transvaginal ultrasound |
| Hysteroscopy | Other | Hysteroscopy was also performed under general anesthesia.Hysteroscopy was performed by a single operator (NNY).The operator and two supervising endoscopists were blinded to the ultrasound results.After the hysteroscopy, endometrial sampling was also done. The diagnoses were compared with the received endometrial samples. Receives: Device: Hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of diagnostic performance transvaginal ultrasonography and hysteroscopy
The main outcome variable of the study was accuracy of diagnostic performance of transvaginal ultrasonography and hysteroscopy in premenopausal and menopausal women with abnormal uterin bleeding .
Measured: up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Jan 2011
- Primary completion31 Dec 2011
- Study completion31 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uterine BleedingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazlı YENIGUL, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Nefise Nazlı YENIGUL, MD, Study director, Sisli Etfal Research and Training hospital, Obstetrics and gynecology department Istanbul, Marmara Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441087
- Sponsor's protocol ID
- 349
- Status last verified
- Feb 2018
- First submitted
- 15 Feb 2018
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound and Hysteroscopy's Place on the Diagnosis of Abnormal Uterin Bleeding
- ClinicalTrials.gov ID
- NCT03441087
- Acronym / sponsor ID
- 349
- Conditions
- Abnormal Uterine Bleeding
- Keywords
- transvaginal ultrasonography, hysteroscopy, abnormal uterine bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2011 (actual)
- Study completion
- 31 Dec 2011 (actual)
- First posted
- 22 Feb 2018 (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.
Although hysteroscopy (HS) and transvaginal ultrasonography (TVSG) are methods in the diagnosis of AUB, there is some suspicion about their efficacy. The aim of this study was to determine the efficacy and safety of HS and TVSG on diagnosing abnormal uterine bleeding(AUB) .216 women admitted to the investigators clinic (Sisli Ethal Training and Research Hospital, Obstetrics and Gynecology Department Obstetrics Service ) between 21-51 years of age. These patients were divided into two groups; menopause (71women) and pre-menopause (145 women). HS and endometrial sampling were performed both groups after TVSG.The success of these methods was assessed by kappa analysis
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvaginal ultrasound | Other | Device: Transvaginal ultrasoundTransvaginal ultrasound was applied 216 women with abnormal uterine bleeding.The transvaginal ultrasound diagnoses were compared with the received endometrial samples. |
| Hysteroscopy | Other | Device: HysteroscopyHysteroscopy was also performed under general anesthesia.Hysteroscopy was performed by a single operator (NNY).The operator and two supervising endoscopists were blinded to the ultrasound results.After the hysteroscopy, endometrial sampling was also done. The diagnoses were compared with the received endometrial samples. |
Who may qualify
- Ages
- 21 to 51 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients who have no history of hysteroscopy and curettage,
- patients who have no history of ovulatory dysfunction
- women who have active vaginal bleeding.
Key exclusion criteria (7 listed)
- presence of genital infections/PID
- presence of pregnancy
- presence of vaginal or cervical pathology causing vaginal bleeding
- women who are receiving hormonal treatment (COC/HRT)
- patients formerly diagnosed with endometrial pathology
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 |
|---|---|---|
| Transvaginal ultrasound | Device | Transvaginal ultrasound |
| Hysteroscopy | Device | Hysteroscopy |
Primary outcome
accuracy of diagnostic performance transvaginal ultrasonography and hysteroscopy
Time frame: up to 12 month
The main outcome variable of the study was accuracy of diagnostic performance of transvaginal ultrasonography and hysteroscopy in premenopausal and menopausal women with abnormal uterin bleeding .
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 26 Feb 2018.
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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.
Nefise Nazlı YENIGUL, MD study director
Sisli Etfal Research and Training hospital, Obstetrics and gynecology department Istanbul, Marmara Turkey
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal ultrasound and Hysteroscopy in people with Abnormal Uterine Bleeding, run by Sisli Hamidiye Etfal Training and Research Hospital.
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 3 inclusion and 7 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 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
accuracy of diagnostic performance transvaginal ultrasonography and hysteroscopy (time frame: up to 12 month). 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 26 Feb 2018.