Conservative Treatment of PAS With or Without IIL

Not Applicable

Recruiting

• Conditions: Cesarean Hysterectomy; Placenta Accreta; Pelvic Devascularization
• Interventions: Procedure: Shehat's technique; Procedure: Ligation of the bilateral internal iliac arteries

• Registration Number: NCT05232981
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-10
• Study Start: 2022-05-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Shehat's technique	Conservative treatment with Shehata's technique and no internal iliac ligation
Study group	Ligation of the bilateral internal iliac arteries	Conservative management of PAS with Ligation of the bilateral internal iliac arteries

Primary Outcome Measures

Name	Time	Method
Cesarean hysterectomy rate	6 months	The success of procedure in prevention of hysterectomy
Intraoperative blood loss	6 months	the volume of blood collected in the suction apparatus, excluding the volume of liquor collected, this will be done by meticulous recording of the blood volume in the suction apparatus before opening the uterus and then calculating the exactly added amount of liquor, so that it becomes excluded from the calculation) to the calculated volume of blood obtained from the pre and postoperative difference in weight of the towels and drapes placed beneath the patients, using the following formula: (WET Item Gram Weight - DRY Item Gram Weight¼milliliters of blood within the item) .

Secondary Outcome Measures

Name	Time	Method
Operative and postoperative complications	6 months	Any operative organ injury
Operative time	intraoperative	From skin to skin duration in minutes

Trial Locations

Locations (1)

Ayman Dawood; 🇪🇬 Tanta, Egypt