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

NCT02822885 | Unknown Results

• 1 other identifier: sleem
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Bleeding

Outcome Measures

Primary Outcomes (5)

• 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

  2 weeks

Study Arms (1)

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

Radiation: Ultrasonography

Interventions

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

Also known as: color Doppler ultrasonography

ultrasonography

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Endometrial thickness ≥ 5 mm measured by two-dimensional transvaginal ultrasound.
• Pap smear is negative for malignancy.

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha university hospitalا

Banhā, Alqalubia, Egypt

Location

Related Publications (2)

• 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.

  PMID: 9528912 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.

  PMID: 15016770 BACKGROUND

Related Links

• Banha university

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Results Point of Contact

• Title: dr khalid M Salama
• Organization: Benha university

dr.khalid_sleem@yahoo.com

01225861026

Study Officials

• Moharam A ABDEL HAEY, MD

  Benha University

  PRINCIPAL INVESTIGATOR

• AHMED WALEED A Mrad, MD

  Benha University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 4, 2016
• Study Start: January 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: April 1, 2017
• Last Updated: March 14, 2017
• Results First Posted: March 14, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)