Conservative Treatment of PAS With or Without IIL (PASIIL)

Conservative Management of Placenta Accreta Spectrum With or Without Internal Iliac Ligation: A Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Placenta Accreta; Cesarean Hysterectomy; Pelvic Devascularization
• Intervention / Treatment: Procedure: Ligation of the bilateral internal iliac arteries; Procedure: Shehat's technique

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayman Dawood, MD; Phone Number: +201020972067; Email: ayman.dawood@med.tanta.edu.eg

Study Locations

• Egypt
  • Tanta, Egypt
    • Recruiting
    • Ayman Dawood
    • Contact: Nahla Elbeheiry, Msc; Phone Number: +201115983165; Email: nahla.elbeheiry@med.tanta.edu.eg
    • Sub-Investigator: Nahla Elbeheiry, Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Conservative management of PAS with Ligation of the bilateral internal iliac arteries	Procedure: 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 .
Active Comparator: Control group; Conservative treatment with Shehata's technique and no internal iliac ligation	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood loss	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) .	6 months
Cesarean hysterectomy rate	The success of procedure in prevention of hysterectomy	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	From skin to skin duration in minutes	intraoperative
Operative and postoperative complications	Any operative organ injury	6 months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Accreta
• Other Study ID Numbers: PASIIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: On valuable request
• IPD Sharing Time Frame: 6 months
• IPD Sharing Access Criteria: full acess
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No