Clinical trial NCT05232981: Conservative Treatment of PAS With or Without IIL
Official title: Conservative Management of Placenta Accreta Spectrum With or Without Internal Iliac Ligation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Placenta Accreta
Cesarean Hysterectomy
Pelvic Devascularization
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the current study, the investigators aimed to compare the benefits of internal iliac ligation in placenta accreta spectrum

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Age under 35 years old.
2. Prenatally diagnosed placenta accreta .
3. Planned caesarean section ≤ 37 wks .
4. ≤ previous 3 ceserian sections .
5. Placenta accretta spectrum grade 1 , 2 ,3 .
6. Patients who want to preserve their fertility.
7. Patients who refuse hysterectomy .

Exclusion Criteria:

1. Cases with high risk of intraoperative blood loss as hemorrhagic disorders and thrombocytopenia .
2. Cases on anticoagulant therapy.
3. Patients who completed her family.
4. Hemodynamicaly unstable patients.
5. Finally cases who refused to get enrolled in the study.

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: 6 months
measure: Cesarean hysterectomy rate
timeFrame: 6 months
Secondary outcomes:
measure: Operative time
timeFrame: intraoperative
measure: Operative and postoperative complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Ayman Dawood
Study officials:
References: