Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03054558 |
| Other study ID # |
C111 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
February 11, 2017 |
| Last updated |
April 8, 2018 |
| Start date |
December 2015 |
| Est. completion date |
April 2019 |
Study information
| Verified date |
April 2018 |
| Source |
Cairo University |
| Contact |
Sherine H Gad Allah, MD |
| Phone |
01097665573 |
| Email |
sheribehosny[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Patients with history of two or more recurrent pregnancy loss (RPL) and no history of living
babies who had performed all investigations for recurrent miscarriage (RM) including :
laboratory investigation ,trans vaginal ultrasound (TVS) ,autoimmune work up and hystroscopy
and all results were free,will be scheduled for three dimensional trans-vaginal ultrasound
(3D TVS) in the midluteal phase for measuring the impedance of uterine artery blood flow( by
two dimensional Power Doppler TVS).Also by using 3D power Doppler the sub-endometrial blood
flow will be assessed. In addition to the thickness of Junctional Zone (JZ) by using coronal
view of 3 D TVS. To be compared with patients who had at least one full term living baby
through normal vaginal delivery with no history of early pregnancy loss.
Description:
Among patients attending the Recurrent pregnancy loss outpatient clinic of kasr Al Aini
teaching hospital, Cairo University .Those meeting investigators inclusion criteria will be
selected for the study. All patients had a history of two or more consecutive, first
trimester miscarriages. Patients with two miscarriages will be included in the study since
equal frequencies of abnormal test results have been demonstrated among patients with two
miscarriages or more . Accordingly, the American College of Obstetrics and Gynecologists
states that the evaluation of couples with two consecutive miscarriages should be initiated.
All women will undergo an extensive examination ,investigations (laboratory ,TVS and
hystroscopy) in order to evaluate all known etiological factors for RPL.
Only Patients with free examination and normal investigations will be enrolled in our study.
Healthy fertile women who attended the outpatient clinic of obstetrics and gynecology in kasr
Al Aini hospital ,Cairo university,for a routine scan will be recruited for the control
group. Inclusion criteria required the absence of previous miscarriages and the presence of
at least one previous uncomplicated pregnancy. Women with a history of pelvic disease or with
abnormal findings during the ultrasound examination were excluded from the study.
The thickness and the morphology of the JZ will be evaluated on the uterine coronal view
obtained by 3D TVS. Endometrial thickness with be measured and subendometrial blood flow (
vascularization index VI ,flow index FI and vascularization flow index VFI ) will be obtained
by 3D power Doppler .
The sonographic evaluation will be performed in the midluteal phase of the cycle (18th to
22nd cycle day), to avoid possible hormonal influences, using an E8 (GE Healthcare, Zipf,
Austria) ultrasound machine equipped with a multifrequency 3D volume endovaginal probe
(2.8-10 MHz).
The examination included a 2D-TVS evaluation of the pelvic organs to exclude any
abnormalities. Transvaginal Doppler flow measurement of the impendence to uterine artery
blood flow was performed.
In order to evaluate the JZ the coronal view of the uterus will be obtained using 3D-TVS. Two
to four static grey-scale volumes of the uterus will be obtained from the sagittal plane and
from the transverse plane. The volume acquisition technique will be performed in a
standardized fashion.
Recent studies indicate that the use of these criteria allow to an assessment of the JZ
reproducible enough to be used in clinical practice. In particular: frequency, 6-9 MHz;
magnification of the uterus up to half of the screen; sweep angle, 1208; sweep velocity will
be adjusted from medium to maximum quality; 3D volume box exceeding the uterus by 1 cm on
each side.
The coronal view reconstruction technique involved placing a straight or curved line
(OmniView or rendering mode) along the endometrial stripe on the sagittal and transverse
views. The multiplanar view was then manipulated until a satisfactory coronal image is
obtained of the uterine external profile and the cavity, with bilateral visualization of the
interstitial portion of the Fallopian tube. Volume contrast imaging (VCI) is applied (2- 4 mm
slice thickness) with volume rendering (mixed light surface and gradient light). Following
acquisition, ultrasound volumes will be stored for subsequent offline analysis. On the
coronal view the JZ appears as a hypo-echoic zone around the endometrium. JZ measurements are
therefore performed only on 3D multi-planar view using VCI. Disruption and infiltration of
the hypo-echoic JZ by the hyper-echoic endometrial tissue are evaluated and the JZ thickness
is measured as the distance from the basal endometrium to the internal layer of the outer
myometrium. The minimum (JZmin), the maximum (JZmax) and the difference between the maximum
and the minimum JZ (JZmax - JZmin) thickness are assessed. The JZmax and the JZmin are
defined as the largest and smallest JZ thickness measured on a coronal or longitudinal
section at any level of the uterus (fundus or anterior, posterior or lateral walls).
