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

Postmenopausal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02822885
• Other study ID #: sleem
• Status: Recruiting
• Phase: N/A
• First received: June 27, 2016
• Last updated: July 1, 2016
• Start date: January 2014
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Benha University
• Contact: khalid M salama
• Phone: 01225861026
• Email: dr.khalid_sleem[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhage
• Postmenopausal Bleeding
• Uterine Hemorrhage

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
Egypt	Benha university hospital?	Benha	Alqalubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

References & 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. Review. — View 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. Epub 2004 Mar 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Doppler indices of spiral arteries	The primary outcome measure is spiral artery Pulsatility index (PI)	two weeks	Yes
Primary	Doppler indices of uterine arteries	The primary outcome measures is uterine artery Pulsatility index (PI)	two weeks	Yes
Primary	Doppler parameters of spiral arteries	The primary outcome measure is spiral artery resistive index (RI)	two weeks	Yes
Primary	Doppler parameters of uterine arteries	The primary outcome measures is uterine artery resistive index (RI)	two weeks	Yes

External Links

•   Banha university