Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05232981 |
| Other study ID # |
PASIIL |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2022 |
| Est. completion date |
October 1, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Tanta University |
| Contact |
Ayman Dawood, MD |
| Phone |
+201020972067 |
| Email |
ayman.dawood[@]med.tanta.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In the current study, the investigators aimed to compare the benefits of internal iliac
ligation in placenta accreta spectrum
Description:
This randomized control trial will be conducted at Tanta University hospital, Egypt, from
2022 to 2024. Tanta University Hospital is considered the main tertiary hospital at the
center of Nile Delta .
Cases, suspected to have PAS, are recruited from the outpatient clinic, and subsequently
transferred for ultrasonod gray scale and dopplar for assessment of placental location,
invasion and commont on the fetus .
Cases are diagnosed to have PAS by the following criteria Placenta lacunae , Loss of clear
zone , Bladder wall interruption, uterovesical hypervascularity and increased vascularity in
inferior part of lower uterine segment extending into parametrial region9 will be included in
the study. MRI will be done if ultrasonod isn't conclusive , cases with posterior placenta,
depth of placental invasion, relationship to posterior bladder wall and presence of
parametrial invasion .
All cases will be subjected to the following:
1. A written consent will be obtained from the patients after informing them about the risk
of intrapartum and postpartum hemorrhage, the need for blood transfusion, and the
possibility of hysterectomy if needed to stop massive blood loss. The consent is
approved by the medical ethical committee of Tanta University Hospital.
2. Full history taking with special attention on:
- Age of the patient .
- Obstetric History especially number of children and sex .
- Detailed history of previous deliveries and gynecological procedures.
- History of any previous surgery.
3. Full general and abdominal examination including weight, height, body mass index (BMI)
and blood pressure.
4. Routine lab investigation : CBC, coagulation profile ( PT , PTT , Bleeding time ,
Clotting time ) , ABO , RH Typing , virology .
Randamisation and Allocation :
Patients will be given aclosed envelope containing either letter C or letter I . The envelope
that opened by patient will not change allocation .
The enrolled cases will be allocated into two groups with 1:1 allocation. Group 1 :( Study
group ) include cases that will undergo bilateral internal iliac arteries ligation .
Group II :( Control group ) will undergo conservative management by three step technique
(Shehata's technique) .
Intervention
Preoperative preparation :
Planned elective CS ≤ 37 wk unless the clinical situations necessitate earlier termination of
pregnancy.
A multidisciplinary team including a two senior obstetricians, vascular surgeon , a
urologist, an anesthesiologist, and a pediatrician are involved in the operation.
Four units of cross-matched blood are prepared for each patient .Ureteric catheters will be
prepared to be used when indicated . Drugs that control bleeding will be preparedsuch as
Oxytocin, Carbetocin, Ergometrine, Misoprostol and Tranexamic acid.
All cases undergo general anesthesia by a specialized team. The operation started with
Pfannenstiel skin incision and careful dissection of urinary bladder till exposing the
uterus.
Uterine incision above placental edge will be done to avoid transplacental incision that
triggers heavy bleeding and then extraction of the baby with ecbolic administration, the
uterus with the placenta inside will be exteriorized outside the abdomen .Redissecion of U.B
will be done if previous dissection at the beginning of the surgery is insuffient.
