Conservative Treatment of PAS With or Without IIL

NCT05232981 | Recruiting

• 1 other identifier: PASIIL
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Placenta Accreta; Cesarean Hysterectomy; Pelvic Devascularization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Operative time

  intraoperative

• Operative and postoperative complications

  6 months

Study Arms (2)

Study group

EXPERIMENTAL

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

Procedure: Ligation of the bilateral internal iliac arteries

Control group

ACTIVE COMPARATOR

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

Procedure: Shehat's technique

Interventions

Ligation of the bilateral internal iliac arteries 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 .

Study group

Shehat's technique 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

Control group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Ayman Dawood

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Central Study Contacts

Ayman Dawood, MD

CONTACT

+201020972067; ayman.dawood@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients only will be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 10, 2022
• Study Start: May 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months
• Access Criteria: full acess

Locations

EG (1)