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Trials / Unknown

UnknownNCT02822885

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
70 (actual)
Sponsor
Benha University · Academic / Other
Sex
Female
Age
50 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
RADIATIONUltrasonographyUltrasonographic 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

Timeline

Start date
2014-01-01
Primary completion
2016-11-01
Completion
2017-04-01
First posted
2016-07-04
Last updated
2017-03-14
Results posted
2017-03-14

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT02822885. Inclusion in this directory is not an endorsement.