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NCT Number: NCT06483724

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

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.

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Key information

About this study

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.

  • 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
  • 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.
  • 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.
  • 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.
  • To remove myometrial tissue, leave a margin of at least 2 cm superior to the cervical internal ostium using electrocautery or scissors.
  • The tourniquet approach achieves hemostasis, giving the operator time to assess the uterus's preservation potential.
  • To assess active bleeding, the tourniquet can be removed.
  • 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.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cervical tourniquet

Procedure

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 .

Uterine artery ligation

Procedure

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 .

Primary outcomes

  1. operation time

    Time frame: intraoperative

    recording total time of the surgery

  2. repair time

    Time frame: intraoperative

    recording length of defect repair from placental separation until uterine wall closure

  3. Estimated blood loss

    Time frame: intraoperative

    recording amount of blood loss

  4. packed red blood cells transfusion

    Time frame: intraoperative until 24 hours after surgery

    recording amount of red blood cell transfused

  5. fresh frozen plasma (FFP) transfusion

    Time frame: intraoperative until 24 hours postoperative

    recording amount of FFP transfusion

  6. Number of Participants who had Bladder injuries

    Time frame: intraoperative until 2 weeks post operative

    Number of Participants who had Bladder injuries

  7. Number of Participants who had ureteral injuries

    Time frame: intraoperative until 2 weeks post operative

    Number of Participants who had ureteral injuries

  8. Number of Participants who had bowel injury

    Time frame: intraoperative until 2 weeks post operative

    Number of Participants who had bowel injury

  9. surgical site infection

    Time frame: 24 hours until 1 month after surgery

    record the presence of wound infection

  10. urine output

    Time frame: intraoperative

    recording amount of urine output

  11. internal iliac artery ligation

    Time frame: intraoperative

    recording if the internal iliac artery ligated whether it was unilateral or bilateral

  12. pre-operative hemoglobin

    Time frame: preoperative

    recording amount of hemoglobin

  13. post-operative hemoglobin

    Time frame: postoperative within 6 hours from surgery

    recording amount of hemoglobin

  14. hospital stay

    Time frame: postoperative until 10 days after surgery

    recording duration of hospital stay after surgery

  15. ICU admission

    Time frame: immediate postoperative until 5 days after surgery

    recording the number of patients admitted to the ICU

  16. HDU high dependency unit admission

    Time frame: postoperative until 10 days after surgery

    recording the number of patients admitted to high dependency unit

  17. surgical diagnosis

    Time frame: intraoperative

    strategy to preserving the uterus when managing placenta accreta versus hysterectomy

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2024
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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