Clinical trial NCT06483724: Comparison Between Cervical Tourniquet and Uterine Artery Ligation Prior to Segmental Resection Approach
Official title: Comparison Between Cervical Tourniquet and Uterine Artery Ligation Prior to the Segmental Resection Approach in Patients With Placenta Accreta Spectrum: A Prospective Interventional Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Placenta Accreta Spectrum
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: operation time
timeFrame: intraoperative
measure: repair time
timeFrame: intraoperative
measure: Estimated blood loss
timeFrame: intraoperative
measure: packed red blood cells transfusion
timeFrame: intraoperative until 24 hours after surgery
measure: fresh frozen plasma (FFP) transfusion
timeFrame: intraoperative until 24 hours postoperative
measure: Number of Participants who had Bladder injuries
timeFrame: intraoperative until 2 weeks post operative
measure: Number of Participants who had ureteral injuries
timeFrame: intraoperative until 2 weeks post operative
measure: Number of Participants who had bowel injury
timeFrame: intraoperative until 2 weeks post operative
measure: surgical site infection
timeFrame: 24 hours until 1 month after surgery
measure: urine output
timeFrame: intraoperative
measure: internal iliac artery ligation
timeFrame: intraoperative
measure: pre-operative hemoglobin
timeFrame: preoperative
measure: post-operative hemoglobin
timeFrame: postoperative within 6 hours from surgery
measure: hospital stay
timeFrame: postoperative until 10 days after surgery
measure: ICU admission
timeFrame: immediate postoperative until 5 days after surgery
measure: HDU high dependency unit admission
timeFrame: postoperative until 10 days after surgery
measure: surgical diagnosis
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: