Balloon Occlusion, Internal Iliac Artery, Placenta Accreta Spectrum
Conditions
Brief summary
This study aims to evaluate the efficacy and safety of bilateral internal iliac artery balloon occlusion in the management of the placenta accreta spectrum.
Detailed description
Placenta accreta spectrum (PAS) is abnormal placental adhesion beyond superficial myometrium, which includes placenta accreta, placenta increta, and placenta percreta. However, there is a desire to preserve the uterus and fertility, so alternatives to hysterectomy are needed. Presently, attempts to avoid hysterectomy include reducing intraoperative hemorrhage such as uterine compression sutures, intrauterine balloon tamponade, pelvic artery ligation, and spiral suturing of the lower uterine segment. Intrauterine balloon tamponade may increase CS scar dehiscence, uterine rupture, and infection. Combined with compression sutures, it may induce uterine necrosis. Placement of balloons in the bilateral internal iliac arteries before caesarean section can reduce uterine artery pressure and intraoperative blood loss during balloon inflation, thus temporarily blocking the main blood supply of the uterus, helping to expose the visual field, shortening the operation time during surgery, and leading to opportunities for timely adjustments to the operative plan during surgery.
Interventions
PROCEDUREConventional management
Patients will be subjected to conventional management for placenta accreta spectrum.
Patients will be subjected to bilateral internal iliac artery balloon occlusion for placenta accreta spectrum.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 to 40 years. * Women with placenta accreta spectrum based on ultrasound (US) and/or magnetic resonance imaging (MRI) findings.
Exclusion criteria
* Women with a bleeding disorder. * History of known allergy to contrast media. * Women with Impaired renal function. * Emergency cesarean section. * Women had severe attack of bleeding before the operation affecting patient's general condition. * Women had previous four or more cesarean scars. * If ultrasound (US) and magnetic resonance imaging (MRI) suspect the presence of placenta accrete preoperative, then intraoperative the placenta is found to have normal adhesion to the uterine wall, this case will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of intraoperative blood loss | Intraoperatively | The amount of intraoperative blood loss will be calculated with reference to the contents of the suction apparatus and to weight of the surgical pads and the hemoglobin concentration difference, immediate preoperative (the morning of cesarean delivery) and postoperative (immediately after cesarean delivery) hemoglobin levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of blood products units transfused | 24 hours postoperatively | Number of blood products units transfused will be recorded. |
| Hospitalization length | 28 days postoperatively | Hospitalization length will be recorded from admission till discharge from hospital. |
| Operation time | From the start till the end of surgery | Operation time will be recorded from start till end of surgery. |
| Intensive Care Unit (ICU) admission rate | 24 hours postoperatively | Intensive Care Unit (ICU) admission rate will be recorded. |
| Intraoperative complications | Intraoperatively | Intraoperative complications such as bladder injury, ureteric ligature, and uterine atony will be recorded. |
| Incidence of hysterectomy | 24 hours postoperatively | Incidence of hysterectomy will be recorded. |
Countries
Egypt
Outcome results
None listed