Vaginal BleedingNCT02385747
Uterine Cavity Assessment and Endometrial Hormonal Receptors in Women With Peri and Post Menopausal Bleeding
A study testing hystroscopy in people with Vaginal Bleeding, run by Cairo University at 1 site in Egypt.
Trial summary
100 women with abnormal uterine bleeding (peri and postmenopausal) were subjected to transvaginal ultrasound , saline sonohysterography , Diagnostic hysteroscopy and fractional curettage followed by histopathological examination and immunohistochemical analysis for estrogen and progesterone receptors. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Vaginal Bleeding
- What is being tested?
- hystroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2015to Feb 2016
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women older than 45 years with Abnormal uterine bleeding for more than 3 months duration
Who cannot join
- history of hormonal treatment or hormonal contraception within the last 6 months. Women who had used IUD or those had hysteroscopy or fractional curettage done within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Uterine Cavity and Endometrial Steroid Receptors in Women With Peri- and Post Menopausal Bleeding
100 women with abnormal uterine bleeding (peri and postmenopausal) were subjected to transvaginal ultrasound , saline sonohysterography , Diagnostic hysteroscopy and fractional curettage followed by histopathological examination and immunohistochemical analysis for estrogen and progesterone receptors.
Read the detailed description
Conventional TVUS will be done to all participants to measure the uterine size \& endometrial thickness and other pathology. TVUS will be done with an empty bladder in the lithotomy position using an endovaginal curved linear probe (EV 4-9/10 ED) with frequency 4-9 MHz.
SIS will be performed for all patients at the same setting of TVUS. With the patient in the lithotomy position, . A 6 or 8 French Foley's catheter will be inserted through the external cervical os into the cervical canal. Its balloon tip will be inflated with 2-3 mL of saline, depending on patient comfort, to help hold it in place. The speculum was then removed.
The vaginal probe was then reinserted and a 5-10 mL syringe filled with sterile saline was attached to the catheter. Fluid will be instilled while the transducer moved from side to side (cornua to cornua) in a long-axis projection then the transducer was rotated 90° into an axial plane. More fluid was instilled while fanning down toward the endocervical canal and up toward the uterine fundus to obtain a detailed survey of the endometrium. Every portion of the uterine cavity should be imaged, to exclude any focal abnormality as polyps, myomas, hyperplasia, and carcinoma. Any detected intrauterine pathology is described; including its shape, size and site.
The hysteroscope used in this study is a rigid continuous flow panoramic hysteroscope, 25 cm in length, 4 mm in diameter with an outer sheath 5 mm diameter and 30° fibro-optic lens.
The technique used to provide constant uterine distention will be by attaching plastic bags of saline. Infusion pressure was elevated by pneumatic cuff under manometric control at a pressure of 100-120 mmHg.
Detailed hysteroscopic examination will be performed under general anesthesia with the patient in the lithotomy position, The thickness, colour, aspect and vasculature of the mucous membrane lining the uterine cavity will be observed and recorded.
Endometrial curettage will be done to all patients, and specimens were fixed in Formalin 10% solution for histopathological examination. Patients in whom endometrial polyps were found by hysteroscopy, had polypectomy performed before curettage. The first sample will be taken from the endocervical canal before hysteroscopy or cervical dilatation. Following diagnostic hysteroscopy, cervical dilatation u. A sharp curette will be introduced into the uterine cavity, and curettage will be done starting with the fundus then posterior, anterior, right and left lateral walls consecutively.
Histopathological examination. All curettage \& polypectomy specimens were embedded in paraffin wax, then slides will be prepared to be stained by the conventional Haematoxylin and Eosin (H \& E) stain.
Detection of estrogen \& progesterone receptors in the specimens (formalin-fixed, paraffin wax-embedded) using immunohistochemical staining which will be carried out by using the Dako ER/PR pharmDx™ Kit which specifically detects the ERα protein as well as the PR-A protein located in the cell nuclei of ER and PR expressing cells, respectively.
- Conditions
- Vaginal Bleeding
- Being tested
- hystroscopy
- Keywords
- perimenopausal bleeding, postmenopausal bleeding, hysteroscopy, Steroid receptors
- Medical subject headings
- Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hystroscopyProcedure or surgery
Detailed hysteroscopic examination under general anesthesia Once the cavity entered, a panoramic view of the uterine cavity then systematic; first the fundus, then anterior, posterior and lateral walls of the uterus consecutively, ending by visualization of the uterine -tubal junctions, The thickness, colour, aspect and vasculature of the mucous membrane lining the uterine cavity was observed and recorded. If there is any intrauterine pathology detected; the shape, size and site were estimated.
| Study group | Role | What they receive |
|---|---|---|
| women with anbormal bleeding | Experimental | women with perimenopausal and postmenopausal bleeding who will be evaluated with transvaginal ultrasound, saline sonohysterography,hystroscopy and endometrial currettage Receives: Procedure: hystroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of endometrial lesion
Measured: 2 days after curretage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal BleedingStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385747
- Sponsor's protocol ID
- 130
- Status last verified
- Mar 2017
- First submitted
- 3 Mar 2015
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Uterine Cavity and Endometrial Steroid Receptors in Women With Peri- and Post Menopausal Bleeding
- ClinicalTrials.gov ID
- NCT02385747
- Acronym / sponsor ID
- 130
- Conditions
- Vaginal Bleeding
- Keywords
- perimenopausal bleeding, postmenopausal bleeding, hysteroscopy, Steroid receptors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 11 Mar 2015 (estimated)
- 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.
100 women with abnormal uterine bleeding (peri and postmenopausal) were subjected to transvaginal ultrasound , saline sonohysterography , Diagnostic hysteroscopy and fractional curettage followed by histopathological examination and immunohistochemical analysis for estrogen and progesterone receptors.
Detailed description
Conventional TVUS will be done to all participants to measure the uterine size \& endometrial thickness and other pathology. TVUS will be done with an empty bladder in the lithotomy position using an endovaginal curved linear probe (EV 4-9/10 ED) with frequency 4-9 MHz.
SIS will be performed for all patients at the same setting of TVUS. With the patient in the lithotomy position, . A 6 or 8 French Foley's catheter will be inserted through the external cervical os into the cervical canal. Its balloon tip will be inflated with 2-3 mL of saline, depending on patient comfort, to help hold it in place. The speculum was then removed.
The vaginal probe was then reinserted and a 5-10 mL syringe filled with sterile saline was attached to the catheter. Fluid will be instilled while the transducer moved from side to side (cornua to cornua) in a long-axis projection then the transducer was rotated 90° into an axial plane. More fluid was instilled while fanning down toward the endocervical canal and up toward the uterine fundus to obtain a detailed survey of the endometrium. Every portion of the uterine cavity should be imaged, to exclude any focal abnormality as polyps, myomas, hyperplasia, and carcinoma. Any detected intrauterine pathology is described; including its shape, size and site.
The hysteroscope used in this study is a rigid continuous flow panoramic hysteroscope, 25 cm in length, 4 mm in diameter with an outer sheath 5 mm diameter and 30° fibro-optic lens.
The technique used to provide constant uterine distention will be by attaching plastic bags of saline. Infusion pressure was elevated by pneumatic cuff under manometric control at a pressure of 100-120 mmHg.
Detailed hysteroscopic examination will be performed under general anesthesia with the patient in the lithotomy position, The thickness, colour, aspect and vasculature of the mucous membrane lining the uterine cavity will be observed and recorded.
Endometrial curettage will be done to all patients, and specimens were fixed in Formalin 10% solution for histopathological examination. Patients in whom endometrial polyps were found by hysteroscopy, had polypectomy performed before curettage. The first sample will be taken from the endocervical canal before hysteroscopy or cervical dilatation. Following diagnostic hysteroscopy, cervical dilatation u. A sharp curette will be introduced into the uterine cavity, and curettage will be done starting with the fundus then posterior, anterior, right and left lateral walls consecutively.
Histopathological examination. All curettage \& polypectomy specimens were embedded in paraffin wax, then slides will be prepared to be stained by the conventional Haematoxylin and Eosin (H \& E) stain.
Detection of estrogen \& progesterone receptors in the specimens (formalin-fixed, paraffin wax-embedded) using immunohistochemical staining which will be carried out by using the Dako ER/PR pharmDx™ Kit which specifically detects the ERα protein as well as the PR-A protein located in the cell nuclei of ER and PR expressing cells, respectively.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women with anbormal bleeding | Experimental | Procedure: hystroscopywomen with perimenopausal and postmenopausal bleeding who will be evaluated with transvaginal ultrasound, saline sonohysterography,hystroscopy and endometrial currettage |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women older than 45 years with Abnormal uterine bleeding for more than 3 months duration
Key exclusion criteria (1 listed)
- history of hormonal treatment or hormonal contraception within the last 6 months. Women who had used IUD or those had hysteroscopy or fractional curettage done within the last 6 months
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 |
|---|---|---|
| hystroscopyDetailed hysteroscopic examination under general anesthesia Once the cavity entered, a panoramic view of the uterine cavity then systematic; first the fundus, then anterior, posterior and lateral walls of the uterus consecutively, ending by visualization of the uterine -tubal junctions, The thickness, colour, aspect and vasculature of the mucous membrane lining the uterine cavity was observed and recorded. If there is any intrauterine pathology detected; the shape, size and site were estimated. | Procedure or surgery | women with anbormal bleeding |
Primary outcome
detection of endometrial lesion
Time frame: 2 days after curretage
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 21 Mar 2017.
Related trials for Vaginal Bleeding
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
Active, not recruitingObservational study
Endometrial Cancer Vaginal Fluid Specimen Collection Study
Abnormal Uterine Bleeding (AUB), Endometrial Cancer
Not yet recruitingObservational study
Expediting Pregnancy of Unknown Location Risk Stratification Using the ROM-Plus Point of Care Test
Pregnancy of Unknown Location (PUL)
Recruiting
Deep Neuromuscular Blockade and a Low-Residue Diet for the Surgical Field in vNOTES Hysterectomy
Leiomyoma, Uterine, Benign Gynecological Disease
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 Maged, MD principal investigator
Kasr Alainy medical school
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hystroscopy in people with Vaginal Bleeding, run by Cairo University at 1 site 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 1 inclusion and 1 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 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
detection of endometrial lesion (time frame: 2 days after curretage). 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 21 Mar 2017.