Postmenopausal BleedingNCT02822885
Uterine Artery and Spiral Artery Doppler Parameters in Patients With Postmenopausal Bleeding
A study testing Ultrasonography in people with Postmenopausal Bleeding, run by Benha University at 1 site in Egypt.
Trial summary
This study was to investigate the diagnostic value of ultrasonography and blood flow measurements in uterine arteries and spiral arteries by transvaginal color Doppler ultrasonography in the detection of the endometrial pathology in women with postmenopausal bleeding. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Postmenopausal Bleeding
- What is being tested?
- Ultrasonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Endometrial thickness ≥ 5 mm measured by two-dimensional transvaginal ultrasound.
- Pap smear is negative for malignancy.
Who cannot join
- Postmenopausal woman on hormon replacement therapy.
- Trans-vaginal examination not possible (Vaginal stenosis or patient refusing trans-vaginal ultrasound).
- Adnexal pathology.
- General causes of bleeding e.g: Hemophilia , anticoagulation therapy
Trial locations and contacts
1 site in 1 country.
About this study
This study was to investigate the diagnostic value of ultrasonography and blood flow measurements in uterine arteries and spiral arteries by transvaginal color Doppler ultrasonography in the detection of the endometrial pathology in women with postmenopausal bleeding.
Read the detailed description
This prospective Cross-sectional Observational study will be conducted at the Department of Obstetrics and Gynecology, Banha University, Egypt during the period starting from January 2014. The study protocol will be approved by the Local Ethics Committee and written informed consent will be obtained from each patient before the study commenced.
Seventy patients with postmenopausal bleeding will be included in the study after verbal consent. They will be recruited from patients attending gynecologic clinic in Banha University hospital.
All patients will be subjected to the following:
For all included women the following will be done:
- Full history taking.
- Complete general, abdominal, and local examination.
- Ultrasonographic assessment of the uterus
All data were performed for all patients in the lithotomy position after they had emptied their bladder using a 7.5 megahertz transducer by a single operator.
- Using colour Doppler in the 2D mode, flow velocity waveforms were obtained from the ascending main branch of the uterine artery on the right and left side of the cervix in a longitudinal plane before they entered the uterus.
- The gate of the Doppler was positioned when the vessel with good colour signals was identified on the screen. Pulsatility index of the uterine arteries were calculated electronically when similar consecutive waveforms of good quality were obtained and the averaged uterine PI. Pulsatility index (PI): This index, also known as the mean pulsatility index, to distinguish it from the peak to peak pulsatility index, is expressed by: PI= (S-D) / Mean Where S is the peak systolic velocity, D is the end diastolic velocity and velocity is the time averaged maximum velocity over the cardiac cycle (1).
- Blood flow velocity waveforms were evaluated in the spiral arteries at the sub endometrial region that is within 1 mm of the originally defined myometrial-endometrial contour (2).
Histopathological diagnosis of endometrium obtained by biopsy is the gold standard for diagnosis.
- Conditions
- Postmenopausal Bleeding
- Being tested
- Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyRadiation
Also called color Doppler ultrasonography
Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
| Study group | Role | What they receive |
|---|---|---|
| ultrasonography | Experimental | Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries Receives: Radiation: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis
Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance
Measured: two weeks
Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis
The primary outcome measure is spiral artery resistive index (RI) .In ultrasonography,it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity.lower values are better than higher values.
Measured: two weeks
Uterine Artery Resistive Index According to Histological Diagnosis
The primary outcome measures is uterine artery resistive index (RI) .In ultrasonography,it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity.lower values are better than higher values.
Measured: two weeks
Uterine Artery Pulsatility Index According to Histological Diagnosis
Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance
Measured: 2 weeks
Endometrial Thickness According to Histological Diagnosis
Endometrial Thickness was assessed by measuring the trilaminar halo of the Endometrial Thickness by trans vaginal sonography
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionNov 2016
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal BleedingStudies of the same condition, open and under way.
- More trials run by Benha 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khalid mohammed salama, Benha University
- Investigators
- Moharam A ABDEL HAEY, MD, Principal investigator, Benha UniversityAHMED WALEED A Mrad, MD, Study director, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822885
- Sponsor's protocol ID
- sleem
- Status last verified
- Jan 2017
- First submitted
- 27 Jun 2016
- Last updated
- 14 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dickey RP. Doppler ultrasound investigation of uterine and ovarian blood flow in infertility and early pregnancy. Hum Reprod Update. 1997 Sep-Oct;3(5):467-503. doi: 10.1093/humupd/3.5.467.
PubMed 9528912Ng EH, Chan CC, Tang OS, Yeung WS, Ho PC. Endometrial and subendometrial blood flow measured during early luteal phase by three-dimensional power Doppler ultrasound in excessive ovarian responders. Hum Reprod. 2004 Apr;19(4):924-31. doi: 10.1093/humrep/deh205. Epub 2004 Mar 11.
PubMed 15016770
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Artery and Spiral Artery Doppler Parameters in Patients With Postmenopausal Bleeding
- ClinicalTrials.gov ID
- NCT02822885
- Acronym / sponsor ID
- sleem
- Conditions
- Postmenopausal Bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Apr 2017 (estimated)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Posted 14 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was to investigate the diagnostic value of ultrasonography and blood flow measurements in uterine arteries and spiral arteries by transvaginal color Doppler ultrasonography in the detection of the endometrial pathology in women with postmenopausal bleeding.
Detailed description
This prospective Cross-sectional Observational study will be conducted at the Department of Obstetrics and Gynecology, Banha University, Egypt during the period starting from January 2014. The study protocol will be approved by the Local Ethics Committee and written informed consent will be obtained from each patient before the study commenced.
Seventy patients with postmenopausal bleeding will be included in the study after verbal consent. They will be recruited from patients attending gynecologic clinic in Banha University hospital.
All patients will be subjected to the following:
For all included women the following will be done:
- Full history taking.
- Complete general, abdominal, and local examination.
- Ultrasonographic assessment of the uterus
All data were performed for all patients in the lithotomy position after they had emptied their bladder using a 7.5 megahertz transducer by a single operator.
- Using colour Doppler in the 2D mode, flow velocity waveforms were obtained from the ascending main branch of the uterine artery on the right and left side of the cervix in a longitudinal plane before they entered the uterus.
- The gate of the Doppler was positioned when the vessel with good colour signals was identified on the screen. Pulsatility index of the uterine arteries were calculated electronically when similar consecutive waveforms of good quality were obtained and the averaged uterine PI. Pulsatility index (PI): This index, also known as the mean pulsatility index, to distinguish it from the peak to peak pulsatility index, is expressed by: PI= (S-D) / Mean Where S is the peak systolic velocity, D is the end diastolic velocity and velocity is the time averaged maximum velocity over the cardiac cycle (1).
- Blood flow velocity waveforms were evaluated in the spiral arteries at the sub endometrial region that is within 1 mm of the originally defined myometrial-endometrial contour (2).
Histopathological diagnosis of endometrium obtained by biopsy is the gold standard for diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasonography | Experimental | Radiation: UltrasonographyUltrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Endometrial thickness ≥ 5 mm measured by two-dimensional transvaginal ultrasound.
- Pap smear is negative for malignancy.
Key exclusion criteria (4 listed)
- Postmenopausal woman on hormon replacement therapy.
- Trans-vaginal examination not possible (Vaginal stenosis or patient refusing trans-vaginal ultrasound).
- Adnexal pathology.
- General causes of bleeding e.g: Hemophilia , anticoagulation therapy
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 |
|---|---|---|
| UltrasonographyAlso: color Doppler ultrasonographyUltrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries | Radiation | ultrasonography |
Primary outcome
Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis
Time frame: two weeks
Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance
Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis
Time frame: two weeks
The primary outcome measure is spiral artery resistive index (RI) .In ultrasonography,it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity.lower values are better than higher values.
Uterine Artery Resistive Index According to Histological Diagnosis
Time frame: two weeks
The primary outcome measures is uterine artery resistive index (RI) .In ultrasonography,it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity.lower values are better than higher values.
Uterine Artery Pulsatility Index According to Histological Diagnosis
Time frame: 2 weeks
Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance
Endometrial Thickness According to Histological Diagnosis
Time frame: 2 weeks
Endometrial Thickness was assessed by measuring the trilaminar halo of the Endometrial Thickness by trans vaginal sonography
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9528912Dickey RP. Doppler ultrasound investigation of uterine and ovarian blood flow in infertility and early pregnancy. Hum Reprod Update. 1997 Sep-Oct;3(5):467-503. doi: 10.1093/humupd/3.5.467.
- Background: PubMed 15016770Ng EH, Chan CC, Tang OS, Yeung WS, Ho PC. Endometrial and subendometrial blood flow measured during early luteal phase by three-dimensional power Doppler ultrasound in excessive ovarian responders. Hum Reprod. 2004 Apr;19(4):924-31. doi: 10.1093/humrep/deh205. Epub 2004 Mar 11.
- Banha universityLink provided by the sponsor.
- 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.
Moharam A ABDEL HAEY, MD principal investigator
Benha University
AHMED WALEED A Mrad, MD study director
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography in people with Postmenopausal Bleeding, run by Benha 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 2 inclusion and 4 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 14 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?
Yes. Results are posted in the registry (first posted 14 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis (time frame: two weeks). The study lists 5 primary outcomes in all. 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 NCT02822885, which also lists 2 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 14 Mar 2017.