Postmenopausal Bleeding
Conditions
Brief 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.
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: 1. Full history taking. 2. Complete general, abdominal, and local examination. 3. 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. 1. 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. 2. 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). 3. 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.
Interventions
RADIATIONUltrasonography
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
Sponsors
Benha University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Endometrial thickness ≥ 5 mm measured by two-dimensional transvaginal ultrasound. 2. Pap smear is negative for malignancy.
Exclusion criteria
1. Postmenopausal woman on hormon replacement therapy. 2. Trans-vaginal examination not possible (Vaginal stenosis or patient refusing trans-vaginal ultrasound). 3. Adnexal pathology. 4. General causes of bleeding e.g: Hemophilia , anticoagulation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis | 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 | 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 | 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 | 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 | 2 weeks | Endometrial Thickness was assessed by measuring the trilaminar halo of the Endometrial Thickness by trans vaginal sonography |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 70 |
| Total | 70 |
Baseline characteristics
| Characteristic | Ultrasonography |
|---|---|
| Age, Customized | 59.85 years STANDARD_DEVIATION 4 |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
Primary
Endometrial Thickness According to Histological Diagnosis
Endometrial Thickness was assessed by measuring the trilaminar halo of the Endometrial Thickness by trans vaginal sonography
Time frame: 2 weeks
Population: All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)~1. Endometrial polyp(N=17)~2. Hyperplasia(N=28)~3. Non-specific(N=15) B-Malignant lesion(N=10)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ultrasonography | Endometrial Thickness According to Histological Diagnosis | endometrial polyp | 18 millimeter | Standard Deviation 3.4 |
| Ultrasonography | Endometrial Thickness According to Histological Diagnosis | endometrial hyperplasia | 7.98 millimeter | Standard Deviation 1.8 |
| Ultrasonography | Endometrial Thickness According to Histological Diagnosis | un specific lesions | 9.56 millimeter | Standard Deviation 2.5 |
| Ultrasonography | Endometrial Thickness According to Histological Diagnosis | all benign lesions | 11.215 millimeter | Standard Deviation 5 |
| Ultrasonography | Endometrial Thickness According to Histological Diagnosis | endometrial cancer | 16.8 millimeter | Standard Deviation 3.4 |
p-value: <0.05t-test, 2 sided
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
Time frame: two weeks
Population: All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)~1. Endometrial polyp(N=17)~2. Hyperplasia(N=28)~3. Non-specific(N=15) B-Malignant lesion(N=10)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ultrasonography | Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis | endometrial polyp(n=17) | 1.08 index | Standard Deviation 0.33 |
| Ultrasonography | Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis | endometrial Hyperplasia(n=28) | 1.22 index | Standard Deviation 0.33 |
| Ultrasonography | Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis | endometrialNon-specif lesions | 1.07 index | Standard Deviation 0.3 |
| Ultrasonography | Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis | all endometrial benign lesions | 1.14 index | Standard Deviation 0.32 |
| Ultrasonography | Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis | endometrial cancer(n=10) | 0.57 index | Standard Deviation 0.09 |
p-value: <0.05t-test, 2 sided
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.
Time frame: two weeks
Population: All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)~1. Endometrial polyp(N=17)~2. Hyperplasia(N=28)~3. Non-specific(N=15) B-Malignant lesion(N=10)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ultrasonography | Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis | all benig endometrial lesions | 0.64 index | Standard Deviation 0.12 |
| Ultrasonography | Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis | endometrial polyp(n=17) | 0.62 index | Standard Deviation 0.05 |
| Ultrasonography | Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis | endometrial hyperplasia(n=28) | 0.68 index | Standard Deviation 0.14 |
| Ultrasonography | Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis | Non-specif endometrial lesions | 0.58 index | Standard Deviation 0.07 |
| Ultrasonography | Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis | endometrial cancer(n=10) | 0.46 index | Standard Deviation 0.03 |
p-value: <0.05t-test, 2 sided
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
Time frame: 2 weeks
Population: All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)~1. Endometrial polyp(N=17)~2. Hyperplasia(N=28)~3. Non-specific(N=15) B-Malignant lesion(N=10)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ultrasonography | Uterine Artery Pulsatility Index According to Histological Diagnosis | endometrial polyp | 0.94 index | Standard Deviation 0.18 |
| Ultrasonography | Uterine Artery Pulsatility Index According to Histological Diagnosis | un specific endometrial lesions | 0.88 index | Standard Deviation 0.2 |
| Ultrasonography | Uterine Artery Pulsatility Index According to Histological Diagnosis | endometrial hyperplasia | 1.21 index | Standard Deviation 0.31 |
| Ultrasonography | Uterine Artery Pulsatility Index According to Histological Diagnosis | all benign endometrial lesions | 1.05 index | Standard Deviation 0.29 |
| Ultrasonography | Uterine Artery Pulsatility Index According to Histological Diagnosis | endometrial cancer lesions | 0.65 index | Standard Deviation 0.09 |
p-value: <0.05t-test, 2 sided
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.
Time frame: two weeks
Population: All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)~1. Endometrial polyp(N=17)~2. Hyperplasia(N=28)~3. Non-specific(N=15) B-Malignant lesion(N=10)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ultrasonography | Uterine Artery Resistive Index According to Histological Diagnosis | endometrial cancer(n=10) | 0.51 index | Standard Deviation 0.04 |
| Ultrasonography | Uterine Artery Resistive Index According to Histological Diagnosis | endometrial polyp.(n=17) | 0.68 index | Standard Deviation 0.12 |
| Ultrasonography | Uterine Artery Resistive Index According to Histological Diagnosis | endometrial hyperplasia.(n=28) | 0.79 index | Standard Deviation 0.1 |
| Ultrasonography | Uterine Artery Resistive Index According to Histological Diagnosis | non specifi endometrial lesions. | 0.73 index | Standard Deviation 0.15 |
| Ultrasonography | Uterine Artery Resistive Index According to Histological Diagnosis | all benign endometrial lesions. | 0.74 index | Standard Deviation 0.13 |
p-value: <0.05t-test, 2 sided