Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03286998 |
Other study ID # |
110149 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 20, 2017 |
Est. completion date |
February 2021 |
Study information
Verified date |
December 2020 |
Source |
Cairo University |
Contact |
Moutaz Elsherbini, M.D. |
Phone |
(+2)01001588300 |
Email |
mizosherbini[@]yahoo.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
A total of 60 women pregnant more than 28 weeks gestation will be recruited from obstetric
outpatient clinic (faculty of medicine -Cairo University Hospital) after being diagnosed of
having placenta previa or low lying placenta by grey scale ultrasound. Placenta will be
reexamined by grey scale ultrasound & color Doppler. Sonographic parameters evaluated will
include placental location, loss of retro-placental clear zone, irregularity and thickness of
the uterine-placental interface, the smallest myometrial thickness in sagittal and transverse
planes, presence of lacunar spaces and bridging vessels & the presence of abnormal
vasculature. The sonographic findings will be compared with intraoperative ones. Hysterectomy
specimen (if any was done) will be evaluated histo-pathologically to assess the degree of
placental invasion & to confirm the accreta status. The aim of the study is to determine the
efficacy of ultrasound in predicting operative findings and associated co-morbidties among
cases of placenta accreta.
Description:
60 pregnant women with singleton living healthy fetus diagnosed as having placenta previa by
grey scale ultrasound and candidate for repeated elective cesarean section (CS) or elective
cesarean hysterectomy (if the diagnosis of placenta accreta is confirmed) will be included in
the study. Inclusion criteria include: maternal age between 20 & 40 years old, gestational
age more than 28 weeks (confirmed by a reliable date for the last menstrual period and 1st
trimester ultrasound scan), one or more cesarean section scar & the presence of placenta
previa with high possibility of being placenta accreta when scanned by grey scale ultrasound.
Women who had chronic or pregnancy induced diseases or any emergency or unplanned CS will be
excluded. Informed consents will be obtained from all patients after explanation of the aim
of the study & the potential risks. For all patients, full history will be taken followed by
complete physical examination & routine obstetric ultrasound (to confirm the presence of
placenta previa i.e. placental tissue covers the internal cervical os or within 2 cm from
it). For all Participants, the placentae will be reexamined in systematic manner by
gray-scale & color Doppler ultrasound via transabdominal and/or transvaginal approach using
Volusion Pro-V ultrasonography machine (GE Healthcare Austria GmbH, Seoul, Korea). All exams
will be done by expert sonographer & the possibility of concomitant placenta accreta will be
checked. The placenta will be scanned with adequate bladder volume to visualize the bladder-
uterine serosal interface correctly & the angle of insonation will kept as low as possible.
The presence of one or more of the following features in grey scale ultrasound will be
indicative of placenta accreta (presence of abnormal placental lacunae / complete loss of
retroplacental sonolucent zone / myometrial thinning / disruption of the uterine
serosa-bladder interface / presence of mass invading the urinary bladder). Similarly,
placenta accreta will be diagnosed by the presence of at least one of the following features
in color Doppler scan: diffuse or focal lacunar flow - sonolucent vascular lakes -
hypervascularity of the utero-vesical interface with bridging vessels connecting the placenta
to the bladder). The sonographic provisional diagnosis (i.e placenta previa, focal accreta,
accreta , increta or percreta) with the concomitant invasion of adjacent structures (e.g.,
the urinary bladder) will be documented. For all participants, termination of pregnancy will
be by elective CS or elective cesarean hysterectomy. Furthermore, operative findings as
regard the placenta and the invasion of adjacent structures will be documented. All operative
procedures will be done by senior staff obstetrician with special interest in placenta
accreta. For hysterectomy specimens, histopathological examination will be done to assess the
degree of myometrial invasion & to confirm the diagnosis of placenta accreta. Maternal
morbidities (i.e. massive bleeding with the need of blood transfusion, pelvic organ injury or
ICU admission) or mortalities will be documented. Neonatal morbidities (i.e. prematurity or
NICU admission) or mortalities will be documented. The ultrasonographic findings will be
compared to operative details and histopathological reports. The aim of the study is to
evaluate the efficacy of ultrasound in predicting operative findings and associated
co-morbidities among cases of placenta accreta.