Conservative Treatment of PAS With or Without IIL

NCT ID: NCT05232981

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-10-01

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.

Conditions

Placenta Accreta; Cesarean Hysterectomy; Pelvic Devascularization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study group

Conservative management of PAS with Ligation of the bilateral internal iliac arteries

Group Type: EXPERIMENTAL

Ligation of the bilateral internal iliac arteries

Intervention Type: PROCEDURE

opening the posterior peritoneum overlying the bifurcation of the common iliac arteries. Then careful dissection of the internal iliac artery is carried out on each side and the anterior division of the internal iliac artery is ligated 4 cm below the bifurcation of the common iliac on both sides by single ligation procedure using Vicryl 1.0 .

Re-checking of the femoral pulsation of both sides is performed. Then, the placenta is removed manually in a piecemeal manner, any remaining bleeding points from the placental site are then controlled by hemostatic sutures .

Control group

Conservative treatment with Shehata's technique and no internal iliac ligation

Group Type: ACTIVE_COMPARATOR

Shehat's technique

Intervention Type: PROCEDURE

The three-step technique (Shehata's technique) entailed 3 steps, the first step is double bilateral ligation of uterine arteries before placental separation. Uterine artery ligation is made at 2 levels. First will be done at the isthmus and second will be done 1 cm above the cesarean incision. Regarding timing of ligation , we will apply the uterine artery ligation before placental separation to minimize blood loss at the attempt of placental separation.

Placenta is separated manually either totally or in piecemeal. If manual separation failed, placenta is removed by scissors.

Application of quadruple sutures is done at the lower uterine segment to compress and secure the neovascularization in the bed of placenta.

Insertion of triple way catheter is commenced from inside the uterine incision downwards using long artery forceps or uterine sound and the pulled by the assistant from below. The catheter balloon is inflated by 50 cc saline and left for 48 hours

Interventions

Ligation of the bilateral internal iliac arteries

opening the posterior peritoneum overlying the bifurcation of the common iliac arteries. Then careful dissection of the internal iliac artery is carried out on each side and the anterior division of the internal iliac artery is ligated 4 cm below the bifurcation of the common iliac on both sides by single ligation procedure using Vicryl 1.0 .

Re-checking of the femoral pulsation of both sides is performed. Then, the placenta is removed manually in a piecemeal manner, any remaining bleeding points from the placental site are then controlled by hemostatic sutures .

Intervention Type: PROCEDURE

Shehat's technique

The three-step technique (Shehata's technique) entailed 3 steps, the first step is double bilateral ligation of uterine arteries before placental separation. Uterine artery ligation is made at 2 levels. First will be done at the isthmus and second will be done 1 cm above the cesarean incision. Regarding timing of ligation , we will apply the uterine artery ligation before placental separation to minimize blood loss at the attempt of placental separation.

Placenta is separated manually either totally or in piecemeal. If manual separation failed, placenta is removed by scissors.

Application of quadruple sutures is done at the lower uterine segment to compress and secure the neovascularization in the bed of placenta.

Insertion of triple way catheter is commenced from inside the uterine incision downwards using long artery forceps or uterine sound and the pulled by the assistant from below. The catheter balloon is inflated by 50 cc saline and left for 48 hours

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Ayman S Dawood, MD

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ayman Dawood

Tanta, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ayman Dawood, MD

Role: CONTACT

ayman.dawood@med.tanta.edu.eg

+201020972067

Facility Contacts

Nahla Elbeheiry, Msc

Role: primary

nahla.elbeheiry@med.tanta.edu.eg

+201115983165

Other Identifiers

PASIIL

Identifier Type: -

Identifier Source: org_study_id