Uterine BleedingNCT03205111
Role of Office Hysteroscope in Premenopausal Uterine Bleeding
An observational study of Uterine Bleeding, run by Assiut University.
Trial summary
The aim of this study is to photographically characterize the endometrium in patients presenting with abnormal uterine bleeding at age group from 20 to 45 years old. and compare dilatation and curettage with hysteroscopy in obtaining an accurate diagnosis of the etiology of abnormal uterine bleeding. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Uterine Bleeding
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Jul 2018
- 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 45 years
- Women only
- Adult
Study population: 100 women between 20 and 45 years of age who presented with complaints of abnormal uterine bleeding will be recruited for this study.
Who may be able to join
- Perimenopausal women complaining of abnormal uterine bleeding.
Who cannot join
- Active pelvic infections
- Medical disorders
- Bleeding tendency
- Hormonal treatment
- Pregnancy
- Contraceptive treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Endometrial Characterization Using Office Hysteroscopy in Women Presenting With Abnormal Uterine Bleeding
The aim of this study is to photographically characterize the endometrium in patients presenting with abnormal uterine bleeding at age group from 20 to 45 years old.
and compare dilatation and curettage with hysteroscopy in obtaining an accurate diagnosis of the etiology of abnormal uterine bleeding.
Read the detailed description
Menstrual dysfunction is the cause of discomfort and disturbed healthy lifestyle. Abnormal uterine bleeding (AUB) is considered as a common problem in premenopausal women. AUB is defined as bleeding from the uterine that is abnormal in volume, regularity, and/or timing.
There are various diagnostic modalities available in the market, ranging from traditional dilation and curettage (D\&C), transvaginal sonography, hysteroscopy and saline infusion sonography. Dilation and curettage is the most widely used simple day care procedure for histological evaluation of the endometrial. It was once considered as the gold standard of investigating women with AUB.
Office hysteroscopy is a very useful technique for diagnosis and treatment of uterine pathology in an office-based environment. It is directly related to the technological explosion, which during the last years has further evolved and given us the opportunity to perform hysteroscopy without providing general anesthesia or sedation to the patients, due to the narrow width of the latest generation hysteroscopes. Hysteroscopic inspection of uterine cavity is a simple and well accepted method. The direct real time visualization, real-color, hydrated, well-illuminated, and augmented vision of the uterine cavity make this diagnostic tool very accurate to detect minute focal endometrial pathology and small lesions and helping us to take well guided direct biopsies.
- Conditions
- Uterine Bleeding
- Medical subject headings
- Uterine Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Hysteroscopic assessment of endometrial pathology
Patterns of endometrial pathology after histopathological examination of the curretings in patients with abnormal uterine bleeding
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study startJul 2017 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uterine BleedingStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Zaki Fahmi, Assiut University
- Investigators
- Ahmed Z. Fahmi, Principal investigator, Assiut UniversityEssam M. Abdallah, Profosser, Study chair, Assiut UniversityHazem S. Mohammed, Professor, Study director, Assiut UniversityKamal M. Zahran, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205111
- Sponsor's protocol ID
- Office Hysteroscope
- Status last verified
- Jun 2017
- First submitted
- 29 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bennett AR, Gray SH. What to do when she's bleeding through: the recognition, evaluation, and management of abnormal uterine bleeding in adolescents. Curr Opin Pediatr. 2014 Aug;26(4):413-9. doi: 10.1097/MOP.0000000000000121.
PubMed 25007322Saadia A, Mubarik A, Zubair A, Jamal S, Zafar A. Diagnostic accuracy of endometrial curettage in endometrial pathology. J Ayub Med Coll Abbottabad. 2011 Jan-Mar;23(1):129-31.
PubMed 22830167Zhu HL, Liang XD, Wang JL, Cui H, Wei LH. Hysteroscopy and directed biopsy in the diagnosis of endometrial carcinoma. Chin Med J (Engl). 2010 Dec;123(24):3524-8.
PubMed 22166624
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Characterization Using Office Hysteroscopy in Women Presenting With Abnormal Uterine Bleeding
- ClinicalTrials.gov ID
- NCT03205111
- Acronym / sponsor ID
- Office Hysteroscope
- Conditions
- Uterine Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 2 Jul 2017 (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.
The aim of this study is to photographically characterize the endometrium in patients presenting with abnormal uterine bleeding at age group from 20 to 45 years old.
and compare dilatation and curettage with hysteroscopy in obtaining an accurate diagnosis of the etiology of abnormal uterine bleeding.
Detailed description
Menstrual dysfunction is the cause of discomfort and disturbed healthy lifestyle. Abnormal uterine bleeding (AUB) is considered as a common problem in premenopausal women. AUB is defined as bleeding from the uterine that is abnormal in volume, regularity, and/or timing.
There are various diagnostic modalities available in the market, ranging from traditional dilation and curettage (D\&C), transvaginal sonography, hysteroscopy and saline infusion sonography. Dilation and curettage is the most widely used simple day care procedure for histological evaluation of the endometrial. It was once considered as the gold standard of investigating women with AUB.
Office hysteroscopy is a very useful technique for diagnosis and treatment of uterine pathology in an office-based environment. It is directly related to the technological explosion, which during the last years has further evolved and given us the opportunity to perform hysteroscopy without providing general anesthesia or sedation to the patients, due to the narrow width of the latest generation hysteroscopes. Hysteroscopic inspection of uterine cavity is a simple and well accepted method. The direct real time visualization, real-color, hydrated, well-illuminated, and augmented vision of the uterine cavity make this diagnostic tool very accurate to detect minute focal endometrial pathology and small lesions and helping us to take well guided direct biopsies.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 100 women between 20 and 45 years of age who presented with complaints of abnormal uterine bleeding will be recruited for this study.
Key inclusion criteria (1 listed)
- Perimenopausal women complaining of abnormal uterine bleeding.
Key exclusion criteria (6 listed)
- Active pelvic infections
- Medical disorders
- Bleeding tendency
- Hormonal treatment
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hysteroscopic assessment of endometrial pathology
Time frame: 7 days
Patterns of endometrial pathology after histopathological examination of the curretings in patients with abnormal uterine bleeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Results publication: PubMed 25007322Bennett AR, Gray SH. What to do when she's bleeding through: the recognition, evaluation, and management of abnormal uterine bleeding in adolescents. Curr Opin Pediatr. 2014 Aug;26(4):413-9. doi: 10.1097/MOP.0000000000000121.
- Results publication: PubMed 22830167Saadia A, Mubarik A, Zubair A, Jamal S, Zafar A. Diagnostic accuracy of endometrial curettage in endometrial pathology. J Ayub Med Coll Abbottabad. 2011 Jan-Mar;23(1):129-31.
- Results publication: PubMed 22166624Zhu HL, Liang XD, Wang JL, Cui H, Wei LH. Hysteroscopy and directed biopsy in the diagnosis of endometrial carcinoma. Chin Med J (Engl). 2010 Dec;123(24):3524-8.
- Individual participant dataSharing planned: No
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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.
Ahmed Z. Fahmi principal investigator
Assiut University
Essam M. Abdallah, Profosser study chair
Assiut University
Hazem S. Mohammed, Professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Bleeding, run by Assiut University.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Jul 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Z. Fahmi (+201020440944, ahmed_zaki_1985@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hysteroscopic assessment of endometrial pathology (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03205111, which also lists 3 linked publications.
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 2 Jul 2017.