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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonography | Radiation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moharam A ABDEL HAEY, MD | Benha University | Principal Investigator |
| AHMED WALEED A Mrad, MD | Benha University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha university hospitalا | Banhā | Alqalubia | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9528912 | Background | 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. | |
| 15016770 | Background | Ng 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. |
| Label | URL |
|---|---|
| Banha university | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)
| Posted | Mean | Standard Deviation | index | two weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| dr khalid M Salama | Benha university | 01225861026 | dr.khalid_sleem@yahoo.com |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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|
| 2 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | 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. | All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)
| Posted | Mean | Standard Deviation | index | two weeks |
|
|
|
|
| Primary | 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. | All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)
| Posted | Mean | Standard Deviation | index | two weeks |
|
|
|
|
| Primary | 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 | All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)
| Posted | Mean | Standard Deviation | index | 2 weeks |
|
|
|
|
| Primary | Endometrial Thickness According to Histological Diagnosis | Endometrial Thickness was assessed by measuring the trilaminar halo of the Endometrial Thickness by trans vaginal sonography | All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)
| Posted | Mean | Standard Deviation | millimeter | 2 weeks |
|
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
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| D055585 |
| Physical Phenomena |
| Title | Measurements |
|---|---|
|
| all benig endometrial lesions |
|
| endometrial cancer(n=10) |
|
| Title | Measurements |
|---|---|
|
| all benign endometrial lesions. |
|
| endometrial cancer(n=10) |
|
| Title | Measurements |
|---|---|
|
| all benign endometrial lesions |
|
| endometrial cancer lesions |
|
| Title | Measurements |
|---|---|
|
| all benign lesions |
|
| endometrial cancer |
|