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CompletedNCT03441087Updated Feb 26, 2018

The Role of TVSG and HS in Determining Endometrial Pathologies

An interventional study of Transvaginal ultrasound and Hysteroscopy in Abnormal Uterine Bleeding, sponsored by Sisli Hamidiye Etfal Training and Research Hospital. Completed. Open to female participants aged 21 Years to 51 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-26.

Sponsored by Sisli Hamidiye Etfal Training and Research Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 7 years 1 month after the study started (first participant enrolled Jan 2011, registered Feb 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
216
Allocation
Non-randomized
Ages
21 Years to 51 Years
Sex
Female
01

Study 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 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

02

Conditions studied

  • Abnormal Uterine Bleeding

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Keywords

  • transvaginal ultrasonography
  • hysteroscopy
  • abnormal uterine bleeding
03

In context

Metrorrhagia

153 studies on the registry are indexed under Metrorrhagia; 35 are open to participants now.

This study's enrollment of 216 is above the median of 100 across 115 interventional studies indexed under Metrorrhagia.

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Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital is the lead sponsor of 114 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 51 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients who have no history of hysteroscopy and curettage,
  • patients who have no history of ovulatory dysfunction
  • women who have active vaginal bleeding.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
216 participants (actual)

Study arms

  • Other
    Transvaginal ultrasound

    Transvaginal ultrasound was applied 216 women with abnormal uterine bleeding.The transvaginal ultrasound diagnoses were compared with the received endometrial samples.

    Device: Transvaginal ultrasound

  • Other
    Hysteroscopy

    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.

    Device: Hysteroscopy

Interventions

  • DeviceTransvaginal ultrasound
  • DeviceHysteroscopy
06

What researchers measure

Primary outcomes

  1. 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 .

    Time frame: up to 12 month

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2011 to primary completion in Dec 2011, 11 months.

Of 41 non-industry interventional studies with no phase under Metrorrhagia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 30. This study's 11 months is below that.

Counting every sponsor, half of 43 studies reached it within 17 months; a quarter within 6 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2018
First posted
Feb 22, 2018
StartActual
Jan 1, 2011
Primary completionActual
Dec 31, 2011
CompletionActual
Dec 31, 2011
Last update
Feb 26, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03441087
Responsible party
Nazlı YENIGUL (Principal Investigator MD, Sisli Hamidiye Etfal Training and Research Hospital) — Principal investigator
First posted
Feb 22, 2018
Start date
Jan 1, 2011
Primary completion
Dec 31, 2011
Completion
Dec 31, 2011
Last update
Feb 26, 2018

Study contacts

Nefise Nazlı YENIGUL, MD
study director · Sisli Etfal Research and Training hospital, Obstetrics and gynecology department Istanbul, Marmara Turkey

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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