Clinical trial NCT02822885: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Postmenopausal Bleeding
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 70
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis
timeFrame: two weeks
measure: Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis
timeFrame: two weeks
measure: Uterine Artery Resistive Index According to Histological Diagnosis
timeFrame: two weeks
measure: Uterine Artery Pulsatility Index According to Histological Diagnosis
timeFrame: 2 weeks
measure: Endometrial Thickness According to Histological Diagnosis
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Benha
country: Egypt
facility: Benha university hospitalا
state: Alqalubia
Study officials:
affiliation: Benha University
name: Moharam A ABDEL HAEY, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Benha University
name: AHMED WALEED A Mrad, MD
role: STUDY_DIRECTOR
References:
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.
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.