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

NCT06483724 | Not Yet Recruiting

• 1 other identifier: Placenta Accreta Spectrum
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Placenta Accreta Spectrum

Outcome Measures

Primary Outcomes (17)

• 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

• 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

• 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

Study Arms (2)

Group 1 (n = 41) cervical tourniquet

EXPERIMENTAL

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

Group 2 (n=41) uterine artery ligation

EXPERIMENTAL

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

Interventions

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 .

Group 1 (n = 41) cervical tourniquet

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 .

Group 2 (n=41) uterine artery ligation

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 3, 2024
• Study Start: July 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share