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Uterine Artery and Spiral Artery Doppler Parameters in Patients With Postmenopausal Bleeding

Primary Purpose

Postmenopausal Bleeding

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasonography
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postmenopausal Bleeding

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Benha university hospitalا

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ultrasonography

Arm Description

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

Outcomes

Primary Outcome Measures

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
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.
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.
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
Endometrial Thickness According to Histological Diagnosis
Endometrial Thickness was assessed by measuring the trilaminar halo of the Endometrial Thickness by trans vaginal sonography

Secondary Outcome Measures

Full Information

First Posted
June 27, 2016
Last Updated
January 24, 2017
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT02822885
Brief Title
Uterine Artery and Spiral Artery Doppler Parameters in Patients With Postmenopausal Bleeding
Official Title
Uterine Artery and Spiral Artery Doppler Parameters in Patients With Postmenopausal Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Bleeding

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ultrasonography
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Ultrasonography
Other Intervention Name(s)
color Doppler ultrasonography
Intervention Description
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
Primary Outcome Measure Information:
Title
Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis
Description
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
Title
Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis
Description
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
Title
Uterine Artery Resistive Index According to Histological Diagnosis
Description
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
Title
Uterine Artery Pulsatility Index According to Histological Diagnosis
Description
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
Title
Endometrial Thickness According to Histological Diagnosis
Description
Endometrial Thickness was assessed by measuring the trilaminar halo of the Endometrial Thickness by trans vaginal sonography
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Endometrial thickness ≥ 5 mm measured by two-dimensional transvaginal ultrasound. Pap smear is negative for malignancy. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moharam A ABDEL HAEY, MD
Organizational Affiliation
Benha University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
AHMED WALEED A Mrad, MD
Organizational Affiliation
Benha University
Official's Role
Study Director
Facility Information:
Facility Name
Benha university hospitalا
City
Benha
State/Province
Alqalubia
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9528912
Citation
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.
Results Reference
background
PubMed Identifier
15016770
Citation
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.
Results Reference
background
Links:
URL
http://www.bu.edu.eg
Description
Banha university

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Uterine Artery and Spiral Artery Doppler Parameters in Patients With Postmenopausal Bleeding

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