Trial Outcomes & Findings for Uterine Artery and Spiral Artery Doppler Parameters in Patients With Postmenopausal Bleeding (NCT NCT02822885)

NCT ID: NCT02822885

Last Updated: 2017-03-14

Results Overview

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

Recruitment status

UNKNOWN

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

two weeks

Results posted on

2017-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	70
Overall Study COMPLETED	70
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultrasonography n=70 Participants 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
Age, Customized	59.85 years STANDARD_DEVIATION 4 • n=93 Participants
Sex: Female, Male Female	70 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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)

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

Outcome measures

Outcome measures
Measure	Ultrasonography n=70 Participants 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
Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis endometrial polyp(n=17)	1.08 index Standard Deviation .33
Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis endometrial Hyperplasia(n=28)	1.22 index Standard Deviation 0.33
Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis endometrialNon-specif lesions	1.07 index Standard Deviation 0.3
Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis all endometrial benign lesions	1.14 index Standard Deviation 0.32
Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis endometrial cancer(n=10)	0.57 index Standard Deviation 0.09

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Ultrasonography n=70 Participants 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
Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis endometrial polyp(n=17)	0.62 index Standard Deviation 0.05
Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis endometrial hyperplasia(n=28)	0.68 index Standard Deviation 0.14
Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis Non-specif endometrial lesions	0.58 index Standard Deviation 0.07
Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis all benig endometrial lesions	0.64 index Standard Deviation 0.12
Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis endometrial cancer(n=10)	0.46 index Standard Deviation 0.03

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Ultrasonography n=70 Participants 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
Uterine Artery Resistive Index According to Histological Diagnosis endometrial polyp.(n=17)	0.68 index Standard Deviation 0.12
Uterine Artery Resistive Index According to Histological Diagnosis endometrial hyperplasia.(n=28)	0.79 index Standard Deviation 0.1
Uterine Artery Resistive Index According to Histological Diagnosis non specifi endometrial lesions.	0.73 index Standard Deviation 0.15
Uterine Artery Resistive Index According to Histological Diagnosis all benign endometrial lesions.	0.74 index Standard Deviation 0.13
Uterine Artery Resistive Index According to Histological Diagnosis endometrial cancer(n=10)	0.51 index Standard Deviation 0.04

PRIMARY outcome

Timeframe: 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)

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

Outcome measures

Outcome measures
Measure	Ultrasonography n=70 Participants 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
Uterine Artery Pulsatility Index According to Histological Diagnosis endometrial polyp	0.94 index Standard Deviation 0.18
Uterine Artery Pulsatility Index According to Histological Diagnosis endometrial hyperplasia	1.21 index Standard Deviation 0.31
Uterine Artery Pulsatility Index According to Histological Diagnosis un specific endometrial lesions	0.88 index Standard Deviation 0.2
Uterine Artery Pulsatility Index According to Histological Diagnosis all benign endometrial lesions	1.05 index Standard Deviation 0.29
Uterine Artery Pulsatility Index According to Histological Diagnosis endometrial cancer lesions	0.65 index Standard Deviation 0.09

PRIMARY outcome

Timeframe: 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)

Endometrial Thickness was assessed by measuring the trilaminar halo of the Endometrial Thickness by trans vaginal sonography

Outcome measures

Outcome measures
Measure	Ultrasonography n=70 Participants 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
Endometrial Thickness According to Histological Diagnosis endometrial polyp	18 millimeter Standard Deviation 3.40
Endometrial Thickness According to Histological Diagnosis endometrial hyperplasia	7.98 millimeter Standard Deviation 1.8
Endometrial Thickness According to Histological Diagnosis un specific lesions	9.56 millimeter Standard Deviation 2.5
Endometrial Thickness According to Histological Diagnosis all benign lesions	11.215 millimeter Standard Deviation 5
Endometrial Thickness According to Histological Diagnosis endometrial cancer	16.8 millimeter Standard Deviation 3.4

Adverse Events

Ultrasonography

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

dr khalid M Salama

Benha university

Phone: 01225861026

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place