Comparison Between Cervical Tourniquet and Uterine Artery Ligation Prior to Segmental Resection Approach

Comparison Between Cervical Tourniquet and Uterine Artery Ligation Prior to the Segmental Resection Approach in Patients With Placenta Accreta Spectrum: A Prospective Interventional Study

The study will compare a modified surgical approach for preserving fertility and minimizing hemorrhage in morbidly adherent placenta during cesarean section with a cervical tourniquet against uterine artery ligation.

Study Overview

• Status: Not yet recruiting
• Conditions: Placenta Accreta Spectrum
• Intervention / Treatment: Procedure: cervical tourniquet; Procedure: uterine artery ligation

Detailed Description

Study Design and Setting This was prospective interventional study that comprised the medical data of 82 pregnant women with placenta accreta who had caesarean section. . This study will be carried out In the Department of Obstetrics and Gynecology, Minia Maternity University Hospital (MMUH) .

after being approved by the local ethical Committee; If placenta accreta was clinically verified preoperatively, all parturients were informed of the option of a hysterectomy. After receiving written, formal consent . After receiving documented formal consent. The study included all patients who had a scheduled cesarean procedure for placenta accreta. Obstetrical imaging either verified or strongly suspected the diagnosis. During the prenatal period, a senior sonographer evaluated all patients using ultrasonography and color Doppler technology. An ultrasonographic assessment was done. Each patient was evaluated for retroplacental sonolucent zones, vascular lacunas, myometrial thinning, bladder line disruption, and exophytic masses . The Color Doppler scan evaluated placental lacunar flow, hypervascularity in the vesicouterine interface, and continuous retroplacental venous complex structures. A 3D Doppler scan was used to assess hypervascularity of the uterine serosa and bladder interphase, as well as uneven intraplacental vascularization

Assessment :

To assess the effectiveness of the proposed management strategy, participants were separated into two groups. In Group 1 (n = 41), a cervical tourniquet was used systematically. In Group 2 (n=41), uterine artery ligation was performed prior to segmental resection for uterine preservation surgery

Surgical scenarios :

Across both groups: Ultrasonographic data determine whether an abdominal incision should be performed with a Pfannensteil or a vertical midline incision from under the umbilicus to above the pubic symphysis.

1. in group 1 After opening the abdominal wall, To reduce bleeding during PAS, make the uterine incision above the placenta's intrauterine borders. Before making the incision, an ultrasound check is recommended to find the uterine opening. Based on our assumptions, following the delivery of the fetus
2. investigators was extract the uterus from the abdomen by gently grasp the fundus of the uterus and pull up and forward. Release uterine appendages on both sides by shifting the uterus to the right and left.
3. An assistant slides a sterile Foley catheter (Ch 16/18 French) down to the lowest point and secures it "en bloc" around the cervix at the level of the uterosacral ligaments, approximately 3-4 cm below the incision. Then, tighten and fix it.
4. The bladder peritoneum is isolated from the uterus through complex coagulation of perforating vascular systems . This step of surgery is crucial for the rest of the treatment. Due to the fragile and unpredictable nature of the vascular network, it is important to exercise caution. The bladder peritoneum is demarcated until the cervical internal ostium. To accomplish this procedure, an assistant places a finger on the anterior fornix of the vagina to create a reference point and assure full separation.
5. To remove myometrial tissue, leave a margin of at least 2 cm superior to the cervical internal ostium using electrocautery or scissors.
6. The tourniquet approach achieves hemostasis, giving the operator time to assess the uterus's preservation potential.
7. To assess active bleeding, the tourniquet can be removed.
8. Suturing on the uterine pouches by suturing on the Uterine pouches is repaired by bringing the edges together with running sutures or using the internal os of the cervix as a natural tamponade helps produce hemostasis in the placental bed and adjacent areas.
9. This approach provides time to prepare for a blood transfusion or seek assistance. The tourniquet approach can be utilized as both a primary therapy strategy for PAS and a follow-up after placental removal and bleeding.

In another group : the same steps in group 1 in steps 1, 2 and 3 4- The bladder peritoneum is isolated from the uterus 5 - The uterine vessels were ligated in continuity at the level of the utero-vesical fold on each side.

6- the same steps in group 1 in steps 5,6, 7and 8

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed sonographically to have placenta accreta spectrum .
• Pregnancy is singleton and fetus is alive.
• Elective caesarean section done from 36 gestational weeks

Exclusion Criteria:

• Patients requesting hysterectomy
• Coexisting uterine pathology such as fibroids or gynaecological malignancies
• Patients with bleeding diathesis.
• Morbid obesity of BMI >40.
• Patients having labour pains or vaginal bleeding before scheduled intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (n = 41) cervical tourniquet; in group 1 the investigators using a sterile Foley catheter (Ch 16/18 French) down to the lowest point and secures it "en bloc" around the cervix at the level of the uterosacral ligaments, approximately 3-4 cm below the incision. Then, tighten and fix .	Procedure: cervical tourniquet; After opening the abdominal wall, To reduce bleeding during PAS, make the uterine incision above the placenta's intrauterine borders . 2-investigators extract the uterus from the abdomen 3-An assistant slides a sterile Foley catheter (Ch 16/18 French) down to the lowest point and secures it "en bloc" around the cervix 4-The bladder peritoneum is isolated from the uterus 5-To remove myometrial tissue, leave a margin of at least 2 cm superior to the cervical internal ostium using electrocautery or scissors .
Experimental: Group 2 (n=41) uterine artery ligation; in group 2the investigators ligated the uterine vessels in a continuous manner at the level of the utero-vesical fold on each side.	Procedure: uterine artery ligation; After opening the abdominal wall, To reduce bleeding during PAS, make the uterine incision above the placenta's intrauterine borders . 2-investigators extract the uterus from the abdomen 3-The bladder peritoneum is isolated from the uterus 4-The uterine vessels were ligated in continuity at the level of the utero-vesical fold on each side 5-To remove myometrial tissue, leave a margin of at least 2 cm superior to the cervical internal ostium using electrocautery or scissors .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operation time	recording total time of the surgery	intraoperative
repair time	recording length of defect repair from placental separation until uterine wall closure	intraoperative
Estimated blood loss	recording amount of blood loss	intraoperative
packed red blood cells transfusion	recording amount of red blood cell transfused	intraoperative until 24 hours after surgery
fresh frozen plasma (FFP) transfusion	recording amount of FFP transfusion	intraoperative until 24 hours postoperative
surgical site infection	record the presence of wound infection	24 hours until 1 month after surgery
urine output	recording amount of urine output	intraoperative
internal iliac artery ligation	recording if the internal iliac artery ligated whether it was unilateral or bilateral	intraoperative
pre-operative hemoglobin	recording amount of hemoglobin	preoperative
post-operative hemoglobin	recording amount of hemoglobin	postoperative within 6 hours from surgery
hospital stay	recording duration of hospital stay after surgery	postoperative until 10 days after surgery
ICU admission	recording the number of patients admitted to the ICU	immediate postoperative until 5 days after surgery
HDU high dependency unit admission	recording the number of patients admitted to high dependency unit	postoperative until 10 days after surgery
surgical diagnosis	strategy to preserving the uterus when managing placenta accreta versus hysterectomy	intraoperative
Number of Participants who had Bladder injuries	Number of Participants who had Bladder injuries	intraoperative until 2 weeks post operative
Number of Participants who had ureteral injuries	Number of Participants who had ureteral injuries	intraoperative until 2 weeks post operative
Number of Participants who had bowel injury	Number of Participants who had bowel injury	intraoperative until 2 weeks post operative

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 29, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 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: placenta accreta spectrum

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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