Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06220760 |
| Other study ID # |
US in Placenta accreta |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 20, 2024 |
| Est. completion date |
September 30, 2025 |
Study information
| Verified date |
January 2024 |
| Source |
Assiut University |
| Contact |
Arsany Medhat, MBBS |
| Phone |
01021808967 |
| Email |
arsany2012[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Using of Ultra sound in assessment of Placenta Accreta Index to predict the surgical outcomes
of Placenta accreta
Description:
Placenta accreta is a substantially life-threatening condition and one of the causes of
maternal morbidity and mortality in the world. According to study done in United Kingdom, The
estimated incidence of placenta accreta/increta/percreta was 1.7 per 10,000 maternities
overall and 577 per 10,000 in women with both a previous caesarean delivery and placenta
previa [1]. in a tertiary south Italian center, The incidence increased from 0.12% during the
1970s, to 0.31% during the 2000s [2].While in USA, the prevalence of placenta accreta was 3.7
per 1000 deliveries [3].
This increase is due to many factors. A scar of previous uterine surgery is a major risk
factor for placenta accreta. Caesarean section scar is the most common one of uterine scars
according to [4] especially in presence of placenta previa where the risk of placenta accreta
was 3%, 11%, 40%, 61%, and 67% for the first, second, third, fourth, and fifth or greater
repeat cesarean deliveries, respectively. [5] reported that both cesarean delivery morbidity
and placenta accreta were positively associated with age >30 years. Previous myomectomy,
multi parity, vigorous curettage are other risk factors as said [6]. More ever sub mucous
leiomyoma and thermal ablation are also contributing factors to Placenta accreta [7] and
lastly [8] said that uterine artery embolization is considered as a risk factor for
occurrence of placenta accreta. Contrarily, inter pregnancy interval more than 60 months was
associated with decreased risk of placenta accreta [9].
Because placenta accreta can lead to life-threatening blood loss, identification of these
high-risk patients would be helpful in management of the pregnancy in addition to enabling
the surgeon to be prepared adequately before the time of delivery. Many studies have been
done on identification of placenta accreta in the third trimester by 2D ultrasound and color
Doppler. There are many modalities for detection of placenta accreta ante natally [10] used
2D ultrasound and color doppler for detection of placenta accreta in 3rd trimester with
sensitivity and specificity; 95.24% and 94.74% respectively for ultrasound with the most
prominent feature presence of multiple lakes that represented dilated vessels extending from
the placenta through the myometrium. For Doppler, the most prominent feature was the presence
of interphase hypervascularity with abnormal vessels linking the placenta to the bladder, and
the rate was 95.24%.
As for surgery for placenta accreta, planned caesarean hysterectomy is recommended to reduce
mortality and morbidity, but fertility is lost. Antenatal diagnosis of placenta accreta
spectrum (PAS) can ensure multidisciplinary management at center of excellence which can
reduce maternal and fetal complications. This can be established by a scoring system which
provides a standardized criterion for the diagnosis and management Placenta Accreta Index
(PAI).
Instead of adhering to the conventional approach that involves an elective caesarean
hysterectomy based on antenatal imaging, more suitable approaches should be considered from
the spectrum of hemostatic and fertility-preserving options available. In our study we will
investigate if the degree of adherence is related to the PAI score. Therefore, we can predict
cases which will need conservative surgery or peripartum hysterectomy. And so that the
surgeon be preplanned to do either hysterectomy or conservative surgery
